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To order copies of the guide, contact:

HRSA Information Center

1-888-275-ASK-HRSA (1-888-275-4772) toll free in the 

2710 Prosperity Ave, Suite 200

Fairfax, VA 22031

The Pocket Guide can also be viewed or ordered on th

HRSA HIV/AIDS Bureau website: 

http://www.hab.hrsa.gov
U.S. Department of Health and Human Services i

February 2006 Edition

A Pocket Guide to 

Adult HIV/AIDS Treatment:

Companion to 

A Guide to Primary Care of 

People with HIV/AIDS

John G. Bartlett, MD 

Professor of Medicine

Chief, Division of Infectious Diseases

Director, AIDS Service

The Johns Hopkins University School of Medicine

Baltimore, Maryland
ii A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Department of Health and Human Services

Health Resources and Services Administration

HIV/AIDS Bureau

Parklawn Building, Room 7-05

5600 Fishers Lane

Rockville MD 20857

http://www.hab.hrsa.gov

Publication date February, 2006

Acknowledgements

Richard W. Dunning, MS, MHS, edited the August 2004 edition. 

Helen Schietinger, MA, ACRN, edited subsequent updates.

Paul Pham, Pharm D, reviewed the manuscript. Cover artwork was 

created by Laura Spofford. Design and layout was done by 

Patrice Lincoln and Jim Concannon. 
U.S. Department of Health and Human Services iii

Table of Contents

References ............................................................................................................. v

Important Information for Users of This Pocket Guide ...................................vi

List of Abbreviations Used in This Pocket Guide ............................................ 1

Drug Information

Drug Table 1. Antiretroviral Agent Characteristics ................................................... 2

Drug Table 2. Antiretroviral Agents, Class Adverse Reactions .................................. 8

Drug Table 3. Antiretroviral Agents, Adverse Reactions: “Black Box” Warnings ......11

Drug Table 4. Combination Antiretroviral Therapy, Dose Adjustments .................. 12

Drug Table 5. Drug Interactions: Contraindicated Combinations ........................... 13

Drug Table 6. Drug Interactions: Nucleosides ........................................................ 14

Drug Table 7. Drug Interactions: Combinations with PIs or NNRTIs 

Requiring Dose Modifications ................................................................ 15

Antiretroviral Therapy

Adult ART Table 1. When to Start Therapy ............................................................ 17

Adult ART Table 2. Suggested Minimum Target Trough Levels ............................... 17

Adult ART Table 3. Starting Regimens for Antiretroviral Naïve Patients ................. 18

Adult ART Table 4. Advantages and Disadvantages of Antiretroviral Regimens ...... 19

Adult ART Table 5. Antiretroviral Regimens or Components 

That Are Not Generally Recommended ................................................. 20

Adult ART Table 6. Laboratory Monitoring ............................................................. 22

Adult ART Table 7. Resistance Mutations ............................................................... 23

Therapeutic Failure ............................................................................................... 25

Adult ART Table 8. Methods to Achieve Readiness to Start HAART & 

Maintain Adherence ............................................................................... 27

Adult ART Table 9. National Cholesterol Education Program: Indications 

for Dietary or Drug Therapy for Hyperlipidemia .................................... 28

Adult ART Table 10. Drug Therapy for Hyperlipidemia ......................................... 29
iv A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Pregnancy and HIV

Antiretroviral Therapy in Pregnancy ..................................................................... 30

Pregnancy Table 1. Preferred Antiretroviral Agents ............................................... 30

Pregnancy Table 2. Antiretroviral Agents: Pharmacokinetic and Toxicity Data ...... 31

Pregnancy Table 3. Antiretroviral Drugs for Delivery ............................................. 32

Pregnancy Table 4. Pregnancy Issues .................................................................... 33

Pregnancy Table 5. Clinical Scenarios and Management of Untreated 

Pregnant Patients Including C-Section ................................................... 33

Pregnancy Table 6. Clinical Scenarios and Management of Treated 

Pregnant Patients Including C-Section ................................................... 34

Pregnancy Table 7. Delivery Procedures and Therapy ........................................... 34

Prevention of HIV for Providers in Three Steps

Step 1: Screen Patients for Risk Behaviors ............................................................ 35

Step 2: Behavioral Interventions ........................................................................... 36

Step 3: Partner Counseling and Notification .......................................................... 37

Opportunistic Infections

Adult OI Table 1. 2001 USPHS/IDSA Guidelines for Prevention of 

Opportunistic Infections ........................................................................ 38

Tuberculosis and HIV ............................................................................................ 42

Adult OI Table 2. Recommended Drug Regimens for Treatment of 

Latent TB in HIV Co-infected Adults ....................................................... 43

Adult OI Table 3. Monitoring of Patients on Latent TB Prophylaxis ........................ 44

Special Considerations for TB Treatment with HIV Co-infection ............................ 45

Adult OI Table 4. Treatment of Drug-Susceptible TB .............................................. 46

Adult OI Table 5. Doses of Antituberculosis Drugs – First-line Drugs ..................... 47

Adult OI Table 6. Management of Opportunistic Infections ..............................48

Occupational HIV Postexposure Prophylaxis (PEP)

Considerations in Occupational Exposure to HIV .................................................. 52

Occupational Postexposure Table 1. Exposure Contingencies ............................... 53

Occupational Postexposure Table 2. Indications for HIV PEP ................................ 54

Management of Health Care Workers (HCWs) With Potential HIV Exposure ......... 55

Occupational Postexposure Table 3. Recommended Regimens ............................. 57

Resources for Consultation ................................................................................... 57
U.S. Department of Health and Human Services v

References: A Pocket Guide to Adult HIV/AIDS Treatment:

• The (DHHS) Guidelines for the Use of Antiretroviral Agents in 

HIV-Infected Adults and Adolescents. (The Living Document: 

October, 6 2005). Available at http://www.aidsinfo.nih.gov/guidelines.

• 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic 

Infections in Persons Infected with Human Immunodeficiency Virus. 

November 28, 2001. Available at http://www.aidsinfo.nih.gov.

• USPHS/IDSA. Treating Opportunistic Infections Among HIV-Infected 

Adults and Adolescents. MMWR Recommendations and Reports 53

(RR15):1-112, December 17, 2004. Available at http://www.aidsinfo.

nih.gov.

• Public Health Service Task Force Recommendations for the Use 

of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for 

Maternal Health and Interventions to Reduce Perinatal HIV-1 

Transmission in the United States. June 23, 2005. Available at 

http://www.aidsinfo.nih.gov.

• ATS/CDC Statement on Targeted Tuberculin Testing and Treatment 

of Latent Tuberculosis Infection. The MMWR Recommendations 

and Reports Vol. 49, No. RR-6, June 9, 2000. Available at 

http://www.cdc.gov/nchstp/tb.

• Incorporating HIV Prevention into the Medical Care of Persons 

Living with HIV: Recommendations of CDC, the Health Resources 

and Services Administration, the National Institutes of Health, and 

the HIV Medicine Association of the Infectious Diseases Society of 

America. MMWR Recommendations and Reports Vol. 52, No. RR-12, 

July 18, 2003. Available at http://www.aidsinfo.nih.gov.

• Integrating Nutrition Therapy into Medical Management of Human 

Immunodeficiency Virus. Clin Infect Dis 2003; 36; Suppl 2:S51-109.

• American Thoracic Society/Centers for Disease Control and 

Prevention/Infectious Diseases Society of America: Treatment of 

Tuberculosis, Am J Respir Crit Care Med 2003;167(4):603. Available at 

http://www.aidsinfo.nih.gov.

• Updated US Public Health Service Guidelines for the Management 

of Occupational Exposures to HIV and recommendations for 

Postexposure Prophylaxis. MMWR 2005;54:RR–9. Available at http://

www.aidsinfo.nih.gov.

• Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug 

Use, or Other Nonoccupational Exposure to HIV in the United States: 

Recommendations from the U.S. Department of Health and Human 

Services. MMWR 2005;54:RR–2. Available at http://www.aidsinfo.nih.gov.
vi A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Important Information for Users of This Pocket Guide

This document is provided as an information resource for 

physicians and other health care professionals to guide them 

in the appropriate treatment of patients with HIV/AIDS. 

Recommendations for care and treatment change rapidly, and 

opinions can be controversial; therefore, physicians and other 

health care professionals are encouraged to consult other sources, 

especially manufacturers’ package inserts, and confirm the 

information contained in these tables. The individual physician 

or other health care professional should use his/her best medical 

judgment in determining appropriate patient care or treatment 

because no single reference or service can take the place of 

medical training, education, and experience. Although these tables 

have been carefully prepared and reviewed, the author makes no 

warranty as to the reliability, accuracy, timeliness, usefulness, or 

completeness of the information. The data presented herein are 

for informational purposes only. Determination of appropriate 

treatment is the responsibility of the treating physician.
U.S. Department of Health and Human Services 1

Abbreviations Used in This Pocket Guide 

Drug Abbreviations

ABC: abacavir (Ziagen) IVIG: intravenous immune globulin

APV: amprenavir (Agenerase) LPV/r: lopinavir/ritonavir (Kaletra)

ATV: atazanavir (Reyataz) NFV: nelfinavir (Viracept)

AZT: zidovudine (Retrovir) NNRTI: non-nucleoside reverse transcriptase inhibitor

CBV: Combivir (AZT+3TC) NRTI: nucleoside reverse transcriptase inhibitor

ddI: didanosine (Videx) NVP: nevirapine (Viramune)

d4T: stavudine (Zerit) PI: protease inhibitor

ddC: zalcitabine (Hivid) RBT: rifabutin (Mycobutin)

DLV: delavirdine (Rescriptor) RTV: ritonavir (Norvir)

EFV: efavirenz (Sustiva) r: ritonavir in dose <400 mg/day

ENF: enfuvirtide (Fuzeon, T-20) SQV: saquinavir (Invirase, Fortovase)

FTC: emtricitabine (Emtriva) TPV: tipranavir (Artivus)

FTV: Fortovase (saquinavir, soft gel cap) 3TC: lamivudine (Epivir)

FPV: fosamprenavir (Lexiva) T-20: enfuvirtide (Fuzeon)

HU: hydroxyurea TDF: tenofovir (Viread)

IDV: indinavir (Crixivan) TMP-SMX: trimethoprim sulfamethoxazole

INH: isoniazid TZV: Trizivir (ABC+AZT+3TC)

INV: Invirase (saquinavir, hard gel cap) VZIG: varicella zoster immune globulin

ZDV: zidovudine (Retrovir)

Miscellaneous Abbreviations

ART: antiretroviral therapy q: every

EC: enteric coated qd: daily

HAART: highly active antiretroviral therapy qid: four times per day

IV: intravenous qm: monthly

IM: intramuscular qod: every other day

VL: viral load qw: every week

bid: twice per day soln: solution

biw: twice per week tid: three times per day

CNS: central nervous system tiw: three times per week

hs: bedtime (hour of sleep) TAMS: thymidine analogue assoc. mutations

mo: month ULN: upper limit of normal

po: by mouth
2 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Drug Information Drug Table 1. Antiretroviral Agent Characteristics (Most common and/or important toxicities are in italics.) Drug Name Form Usual Adult Dose Food Effects Renal Failure Dosing Liver Failure Dosing Toxicity (main toxicity – italics) CrCl 30-59 mL/min CrCl 10-29 mL/min CrCl < 10 or dialysis Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Abacavir (ABC, Ziagen) 300 mg tab (see also: Trizivir); 20 mg/mL po soln 300 mg bid No effect Standard Usual Hypersensitivity: fever, rash, GI sx, dyspnea§¶¶ Combivir (CBV) AZT 300 mg + 3TC 150 mg (tab) 1 bid No effect Fixed formulation not recommended Usual AZT side effects§ Didanosine 

(Videx EC; ddI)†

125, 200, 250, and 400 mg EC caps††

>60 kg <60 kg 1⁄2 hr before 

or 2 hr after mealSeparate dosing of ATV, TPV/r

>60 kg 200 mg/d <60 kg 125 mg/d

>60 kg 125 mg/d <60 kg 100 mg/d

>60 kg 125 mg/d <60 kg 75 mg/d¶

Usual

Pancreatitis, peripheral neuropathy, GI intolerance §

EC Caps 400 mg qd 250 mg qdwith TDF 250 mg/d 200 mg/d

Emtricitabine (Emtriva, FTC) 200 mg cap 200 mg qd No effect 200 mg q72 h 200 mg q96 h Usual Minimal§ HBV flare »Lamivudine (Epivir; 3TC)

150, 300 mg tab (see also: Combivir & Trizivir); 10 mg/mL po soln

150 mg bid or 300 mg qd No effect 150 mg x 1 then 100 mg/d 150 mg x 1 then 25-50 mg/kg/d Usual Minimal§ HBV flare »
U.S. Department of Health and Human Services 3

Epzicom 3TC 300 mg + ABC 600 mg 1 qd No effect Fixed formulation not recommended in renal failure Usual ABC hypersensitivity, HBV flare »Stavudine (Zerit; d4T) †

15, 20, 30, 40 mg cap 1 mg/mL po soln

Wt >60 kg: 40 mg bid Wt <60 kg: 30 mg bid No effect

>60 kg 20 mg q 12 h<60 kg 15mg q 12 h

>60 kg 20 mg q 24 h<60 kg 15 mg q 24 h

>60 kg 20 mg q 24 h<60 kg 20 mg q 24 h¶

Usual

Peripheral neuropathy, pancreatitis, lipoatrophy,ascending paresis (rare)§

Tenofovir (Viread, TDF)

300 mg tab(see also: Truvada)

300 mg qd Take with meal 300 mg q 48 hr 300 mg 2 days/wk 300 mg q 7 days¶ Usual Minimal. Renal toxicity (rare)§ HBV flare »

Trizivir (TZV)

AZT 300 mg + 3TC 150 mg + ABC 300 mg (tab)

1 bid No effect Fixed formulation not recommended in renal failure Usual

Hypersensitivity reaction (ABC), bone marrow suppression (AZT), GI Intolerance (AZT)§HBV flare »

Truvada TDF 300 mg + FTC 200 mg 1 qd No effect Fixed formulation not recommended in renal failure Usual Minimal. Renal toxicity, HBV flare »
4 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Drug Table 1. Antiretroviral Agent Characteristics – continued (Most common and/or important toxicities are in italics.) Drug Name Form Usual Adult Dose Food Effects Renal Failure Dosing Liver Failure Dosing Toxicity (main toxicity – italics) CrCl 30-59 mL/min CrCl 10-29 mL/min CrCl < 10 or dialysis Zidovudine 

(Retrovir, AZT)

100 cap, 300 mg tab (see also: Combivir & Trizivir)10 mg/mL IV soln10 mg/mL po soln

300 mg bid200 mg bid No effect 300 mg bid 300 mg qd 100 mg tid Usual

Peripheral neuropathy,stomatitis§

Protease Inhibitors (PIs)

Atazanavir (Reyataz, AZT)

100, 150, and 200 mg capsules

400 mg qd; ATV 300 mg/RTV 100 mg qd. Boosting is often preferred and is required if ATV is combined with TDF or EFV

Take with foodAvoid concurrent buffered ddl, antacids

Standard

CPS* 7-9: 300 mg qd CPS* >9: Avoid

Benign increase in indirect bilirubin, GI intolerance, transaminitis, prolongation of QTc (caution with conduction defects or drugs that do this) ‡‡

Fosamprenavir ††(FPV, Lexiva) 700 mg tabs 

1400 mg bid or 700 mg/RTV 100 mg bid or 1400 mg/RTV 200 mg qd

No effect Standard

CPS* 5-8: 700 mg bid CPS* >9: Avoid

Rash, GI intolerance, transaminitis, headache, hepatitis ‡‡
U.S. Department of Health and Human Services 5

Indinavir (IDV, Crixivan)

200, 333, 400 mg caps 

800 mg q 8h; separate buffered ddI ≥ 1 hrIDV 400 mg/RTV 400 mg bid or #IDV 800 mg/RTV 100-200 mg bid #

1 hr before or 2 hr after meal unless with RTV

Standard 600 mg q8h

GI intolerance, nephrolithiasis, transaminitis, benign increase in indirect bilirubin ‡‡

Lopinavir/ Ritonavir (LPV/r) (Kaletra)

200/50 mg tabs; LPV 80 mg + RTV 20 mg/mL po soln††

400 mg LPV + 100 mg RTV (2 tabs) bidSoln: 5 mL bid No effect Standard §§ 

Transaminitis, GI intolerance(esp diarrhea), asthenia ‡‡

Nelfinavir (NFV, Viracept)

250, 625 mg tabs50 mg/g powder

1250 mg bid or 750 mg tid

Take with high fat meal

Standard §§ 

GI intolerance,diarrhea, transaminitis‡‡

Ritonavir (RTV, Norvir) 

100 mg caps 600 mg/ 7.5 mL po soln

600 mg q12h #; separate ddI ≥ 2 h

Food improves GI tolerance

Standard §§ 

GI intolerance, paresthesia, transaminitis, taste perversion ‡‡

Saquinavir †† (SQV, Invirase)

200 mg caps500 mg tabs

SQV 1000 mg bid + RTV 100 bid ††SQV 2000 mg qd + RTV 100 mg qd †† 

Take within 2 hours of meal

Standard §§ GI intolerance, transaminitis ‡‡

Tipranavir(TPV, Apitivus) 250 mg caps 500 mg bid with RTV 200 mg bid

Take TPV and RTV with food

Standard CPS B or C: Avoid

Hepatotoxicity– monitor ALT, skin rash, GI intolerance, multiple drug interactions
6 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Drug Table 1. Antiretroviral Agent Characteristics – continued (Most common and/or important toxicities are in italics.) Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Delavirdine (DLV, Rescriptor) 100, 200 mg tabs 400 mg tid No effect Standard §§ Rash Efavirenz ††† (EFV, Sustiva) 50, 100, 200 mg caps 600 mg tabs 600 mg hs Avoid high fat meal Standard §§ CNS x 2-3 wks, rash, hepatitis, false + cannibinoid test Nevirapine (NVP, Viramune) 200 mg tabs 50 mg/5 mL po susp 200 mg qd x14 days, then 200 mg bid No effect Standard Standard; give post dialysis Avoid Rash, hepatitis, hepatic necrosis esp women with CD4 >250 in first 6 wks Fusion Inhibitors Enfuvirtide (ENF, Fuzeon, T-20) 90 mg single- use vials to be reconstituted with 1.1 mL H20 90 mg (1 mL) SQ q12h into upper arm, anterior or abdomen (rotate sites) N/A Standard Usual Dose Site reactions
U.S. Department of Health and Human Services 7

†

The combination of ddI & d4T “should be used in pregnant women only when the potential benefit clearly outweighs the potential risk.” Efavirenz should be avoided in first trimester of pregnancy and used with caution in women with reproductive potential. Avoid APV liquid in pregnancy.

†† The following are no longer available: buffered ddI, lopinovir/r 133/33 mg cap, amprenavir, or Fortovase.

‡ Drug change or dose change could be considered on a case-by-case basis noting the risk of resistance with underdosing. ** Capsule is the preferred formulation due to high propylene glycol in the po solution; po soln contraindicated in pregnancy.§ Class adverse reaction: lactic acidosis with steatosis (see Drug Table 2). Most common with d4T, ddl, and AZT.

# See Drug Table 4 for dosing recommendations when using dual PI, PI plus NRTI, or dual PI plus NNRTI.

¶ Give post dialysis * CPS=Child Pugh Score

¶¶ Registry for hypersensitivity 1-800-270-0425 §§

More frequent monitoring required. Drug change or dose change could be considered on a case-by-case basis noting the risk of resistance with underdosing.

††† Efavirenz should be avoided in first trimester of pregnancy and used with caution in women with reproductive potential. Avoid APV liquid in 

pregnancy.

‡‡

Class adverse effects include lipodystrophy with hyperglycemia, fat redistribution, hyperlipidemia, and possible increased bleeding with hemophilia. ATV does not cause hyperlipidemia. All PIs may cause elevated transaminases (see Drug Table 2).

» 3TC, FTC, and TDF: Risk of flare of chronic HBV if discontinued.
8 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Drug Table 2. Antiretroviral Agents, Class Adverse Reactions Reaction Lactic acidosis Hepatotoxicity Hyper- glycemia Fat redistribution Hyper- lipidemia Rash Definition Lactic acid >2 mmol/mL usually >5 mmol/mL Gr III = AST/ALT 5-10 X ULN GR IV = AST/ALT > 10 x ULN Fasting glucose >126 mg/dL Fat accumulation Lipoatrophy See Adult ART Table 5 DRESS* (NVP, ABC) SJS, TEN (NVP, EFV, DLV) ABC hypersensitivity Frequency 1.3% NRTI recipients with median onset at 4 mo NRTIs: d4T, ddI, AZT (lactic acidosis) PIs: (15-30%) NVP: 11% in first 6 wks in women with baseline CD4 >250; possible hepatic necrosis and death NNRTI: (8-15%) 3-17% with PIs 4-50% ABC hypersensitivity: 5-8%, 90% in 1st 6 wks EFV, NVP: 8-16% most in 1st 6 wks Agents NRTIs: d4T+ddI>d4T> ddI>AZT; rare with 3TC, ABC, FTC or TDF NRTI: Lactic acidosis with steatosis NVP: Hepatic necrosis PIs, NNRTIs: transaminitis PIs Fat accumulation: PIs Lipoatrophy: NRTIs esp d4T Also occurs without antiretrovirals PI: esp RTV; not noted with ATV and reduced frequency with FPV NNRTI: NVP > EFV & DLV PIs: FPV, increased risk with sulfa allergy NRTI: ABC*
U.S. Department of Health and Human Services 9

Risk Factors

Prolonged use NRTI (esp d4T)Female, pregnancy, obesity, ribavirin, metformin

HCV or HBV infection, ETOH, male sex NVP: baseline CD4 >250 in female, > 400 in male

Pre-existing glucose intolerance No clear risks defined

Risk for CVD: HBP, smoking, obesity, genes, prior MI/stroke, diabetes, age 

ABC: genetic predispositionNNRTI: 1st 12 wksFemale

Sx 

GI (abd pain, anorexia, nausea, vomiting), wasting, dyspnea, cardiac arrhythmias 

Most common: asymptomatic 

ALT/AST due to all PIs and 

NNRTIsNVP: may cause lethal hepatonecrosisNote: indirect bilirubin with IDV or ATV is clinically inconsequential but may cause jaundice

Polyuria, polydipsia, polyphagia, weight loss 

Fat accumulation: abd (visceral), buffalo hump, breasts, lipomasFat atrophy: face, extremities, buttocks 

Cardiovascular disease with stroke or MI/anginaTriglycerides >2000 mg/dL - pancreatitis

Common: MP rashSevere: Stevens-Johnson synd, TEN#, DRESS*NVP : hepatonecrosis with fever, rash, and/or GI sx 1st 16 wksABC hypersensitivity: ≥ 2 systems involved 1st 6 wks

Lab

Lactate >2 mmol/mL; life-threatening if >10 mmol/mL 

LFTs; liver biopsy is usually not helpful. 

Fasting glucose >126 mg/dL 

Appearance is best “lab test”, CT scan, MRI, waist and hip measurement, Bioelectric Impedence Analysis, DEXA, ultrasound 

 triglycerides cholesterol, 

LDL cholesterol

Eosinophilia: variable
10 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Drug Table 2. – continued Antiretroviral Agents, Class Adverse Reactions Reaction Lactic acidosis Hepatotoxicity Hyper- glycemia Fat redistribution Hyper- lipidemia Rash Treatment Lactate 2-5 mmol/mL + Sx -D/C NRTI if sx severe Lactate level is 5-10 mmol/mL: D/C NRTIs. Lactate >10 mmol/mL (medical emergency): D/C NRTIs + supportive care (ventilator, dialysis, IV HCO3) IV thiamine or riboflavin (?) Post recovery: use low risk NRTIs (3TC, FTC, TDF) or avoid class Hypersensitivity reactions to ABC or NVP (fever, eosinophilia, rash, systemic response usually in first 6-18 wks): D/C drug immediately and do not rechallenge Asymptomatic elevations of LFT (<10x ULN): repeat LFTs q 1-2 wks Symptomatic or elevations of LFT (>5–10x ULN) or hyperlactatemia or hypersensitivity (ABC or NVP): D/C ART or change regimen. Some “treat through” asymptomatic ALT >10x ULN. ALT may return to baseline or persist; liver biopsy usually not helpful Use standard diabetes treatment with diet and exercise Preferred hypoglycemics are metformin or thiazolidinediones D/C PI only if uncontrolled hyperglycemia D/C d4T, ddI, AZT for fat atrophy Cosmetic surgery Exercise? Change PI to ATV or NNRTI Lipoatrophy: D/C d4T NECP guidelines (pg 29): • General † • LDL cholesterol Statins • Triglycerides fibrate Most rashes do not require drug discontinuation D/C drug if blisters, bullae, mucous membranes involved, fever, elevated ALT/AST Withdraw NNRTI if severe: mucous membrane involvement (SJS); blisters or bullae, epidermal necrosis (TEN), systemic reaction (fever, arthralgia, myalgias) Treatment: IV fluids, antipyretics, pain management, care in burn unit. Role of steroids not clear. Do not rechallenge NVP and ABC: rash as component of DRESS* or ABC hypersensitivity or NVP hepatonecrosis reaction: D/C drug and supportive care Monitor During Therapy None LFTs at baseline and q 3-6 mo NVP: LFTs at wks 0,2,4,8,12,16 then q 3 mo Fasting glucose baseline, at 3-6 mo, then yearly Appearance Fasting lipid profile at baseline, at 3-6 mo post HAART initiation, then yearly. Appearance *DRESS: (Drug Rash, Eosinophilia, & Systemic Symptoms) Life threatening complication that is seen with NVP and ABC - usually in the first 6 weeks of therapy †Lifestyle changes: d/c smoking, diet, weight reduction, exercise, tx HBP and diabetes # TEN: Toxic epidermal necrolysis
U.S. Department of Health and Human Services 11

Drug Table 3. Antiretroviral Agents, 

Adverse Reactions: “Black Box” Warnings

Agent Reaction

Abacavir • Fatal hypersensitivity reactions: do not restart

• Lactic acidosis and steatosis

Amprenavir Oral soln contains large amounts of propylene glycol: avoid with renal failure, 

hepatic failure, pregnancy, & metronidazole

Atazanavir None

Delavirdine None

Didanosine 

Fatal and nonfatal pancreatitis: do not restart

Lactic acidosis with steatosis

Fatal lactic acidosis when combined with stavudine in pregnancy

Efavirenz None

Emtricitabine Lactic acidosis with steatosis

Enfuvirtide None

Indinavir None

Lamivudine 

Lactic acidosis with steatosis

Patients with HBV infection should receive only dosage and formulations 

appropriate for treatment of HIV

Lopinavir None

Nelfinavir None

Nevirapine 

Hepatotoxicity including fulminant and cholestatic hepatitis & hepatic necrosis: 

monitor intensively in first 18 wks of therapy

Severe, life-threatening skin reaction including toxic epidermal necrolysis 

(TEN), Stevens-Johnsson syndrome, etc

Do not restart if there is serious liver injury or serious drug reaction

Ritonavir Potentially serious drug interactions with nonsedating antihistamines, sedative 

hypnotics, antiarrhythmics, or ergot alkaloids

Stavudine 

Lactic acidosis with steatosis

Fatal and non-fatal pancreatitis

Fatal lactic acidosis when combined with didanosine in pregnancy

Tenofovir Lactic acidosis and steatosis; discontinuation in pts with HBV co-infection may 

cause exacerbation of acute HBV

Tipranavir Hepatotoxicity including clinical hepatitis and hepatic decompensation

Zalcitabine 

Severe peripheral neuropathy

Pancreatitis (rare)

Hepatic failure in patients with HBV infection (rare)

Lactic acidosis and steatosis

Zidovudine Hematologic toxicity: anemia & leucopenia

Lactic acidosis and steatosis
12 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Drug Table 4. 

Combination Antiretroviral Therapy, Dose Adjustments*

RTV SQV NFV FPV LPV/r ATV NVP EFV

IDV

IDV 

400+ 

RTV 400 

bid or

IDV/r 

800/ 

100-200 

bid

ND

IDV 

1200 

+ NFV 

1250 

bid

IDV-SD 

APV-SD ND NR

NVP-SD

IDV 1000 

q8h

EFV-SD

IDV- 1000 

q8h or EFV 

SD/ IDV 

800 bid/ 

RTV 200 

bid

RTV -

SQV/r 

1000/100 

or 

400/400 

bid

-

FPV/r 

1400/ 

200 qd or 

700/ 100 

bid

co-formulated

ATV/r 

300/100 

qd

NVP-SD

RTV-SD

EFV-SD

RTV-SD

SQV - -

NFVSD + 

SQV 

1200 

bid or 

SQV 

800 

tid

ND

SQV 

1000 bid 

+ LPV/rSD

SQV 1200 

+ ATV 

400 qd 

NVP-SD + 

SQV/RTV 

400/400 

bid or 

1000/100 

bid

EFV-SD + 

SQV/RTV 

400/400 

bid

NFV - - - ND ND ND NVP-SD

NFV-SD

EFV-SD

NFV-SD

FPV - - - - NR ND ND

EFV-SD

FPV/r 

1400/300 

qd or 

700/100 

bid

LPV - - - - - ND

NVP-SD

LPV/r 

533/133 

bid

EFV-SD

LPV/r 

533/133 

bid

ATV - - - - - - ND

EFV-SD 

+ ATV/r 

300/100 

qd

TPV**

* Doses are in mg; ND = Inadequate data; NR = Not recommended; SD = Standard dose;

**TPV must be combined with RTV and should not be combined with any other PI
U.S. Department of Health and Human Services 13

Drug Table 5. 

Drug Interactions: Contraindicated Combinations

Class Contraindicated 

Agent ART Agents Alternatives

Ca++ channel blocker Bepridil RTV, ATV, FPV, TPV -

Antiarrythmics 

Flecainide, 

Propafenone RTV, LPV/r, TPV -

Amiodarone, quinidine RTV, IDV, TPV

Lipid lowering Simvastatin, Lovastatin All PIs, DLV 

Pravastatin or 

Fluvastatin, possibly 

Atorvastatin, 

Rosuvastatin

Antimycobacterials

Rifampin All PIs; all NNRTIs 

except EFV Use Rifabutin*

Rifabutin DLV, SQV (unless used 

with RTV) -

Rifapentine All PIs, NVP, DLV, EFV Rifampin or rifabutin

Antihistamine Astemizole, 

Terfenadine All PIs, DLV, EFV 

Loratadine, 

Fexofenadine, 

Cetirizine, or 

Desloratidine

Antineoplastics Irinoteacan ATV -

GI 

Cisapride All PIs, DLV, EFV 

- H2 blockers, proton 

pump inhibitors DLV, ATV

Neuroleptic Clozapine RTV -

Pimozide All PIs -

Psychotropic 

Midazolam† 

Triazolam All PIs, DLV, EFV Temazepam, 

Lorazepam Alprazolam DLV

Ergot alkaloids Ergotamine All PIs, DLV, EFV Consider Sumatriptan

Herbs St. John’s wort All PIs & EFV, DLV, NVP Alternative 

antidepressants

Miscellaneous Fluticasone RTV and all RTV/PI 

combinations

* See Drug Table 7, pg 14 for Rifabutin and antiretroviral dose adjustments

† Midazolam may be used with caution as a single dose given for a procedure
14 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Drug Table 6. 

Drug Interactions: Nucleosides

Drug AZT d4T ddI TDF

Methadone 

AZT AUC 43%; 

no dose change; 

monitor for AZT 

toxicity

d4T 27%; 

no dose change - 

No change in 

methadone or 

TDF levels

ddI - Magnifies toxicity 

Use with caution - 

ddI 44% 

Pt >60 kg: 250 

mg/d (ddI) 

Pt <60 kg: 200 

mg/d (ddI)

Ribavirin 

Inhibits AZT 

activation; avoid 

if possible

No data Magnifies ddI 

toxicity; avoid No data

ATV - - 

ddI EC: separate 

dosing due to 

food restrictions

Avoid concomitant 

use unless ATV 

combined with 

RTV

Cidofovir 

Ganciclovir 

Valgancyclovir

Ganciclovir + 

AZT marrow 

toxicity

Monitor CBC

- -

Combinations 

may decrease 

CrCl

LPV/r No data No data No data

TDF AUC 34% 

Standard doses 

and monitor for 

TDF toxicity

TPV

AZT AUC

31–42%

Right dose? 

- TPV Cmin 44% 

with ddI EC

Separate by 2 hrs
U.S. Department of Health and Human Services 15

Drug Table 7. 

Drug Interactions: Combinations with 

PIs or NNRTIs Requiring Dose Modifications

Class Agent ART

Antifungal 

Ketoconazole 

IDV: IDV 600 mg tid

RTV, LPV/r: Ketoconazole ≤ 200 mg/d, FPV ≤ 400 mg/d

NVP: Not recommended

Voriconazole 

Current use with RTV (≥ 400 mg/d) or EFV is 

contraindicated; no data for NNRTIs, NFV, ATV, TPV, FPV, 

LPV/r but bidirectional interaction anticipated; Monitor for 

toxicity; IDV is OK

Itraconazole IDV and TPV: itraconazole dose ≤ 200 mg or monitor 

levels

Oral 

contraceptives -

Additional method of contraception recommended with: 

RTV, NFV, EFV, LPV/r, NVP, FPV. (IDV & ATV are OK)

No data for SQV

Anticonvulsants 

Phenobarbital, 

Phenytoin, 

Carbamazepine

Avoid carbamazepine + IDV and phenytoin + LPV; 

all other combinations of NNRTIs or PIs & designated 

anticonvulsants should be given with caution and 

monitoring of anticonvulsant levels or consider 

valproic acid

Methadone -

NVP and EFV may decrease methadone substantially; 

monitor for withdrawal 

IDV has no interaction; other PIs may cause modest 

decrease in methadone levels and require monitoring for 

withdrawal 

Methadone decreases buffered ddI levels - consider ddI 

EC (no interaction).

Antibiotics Clarithromycin 

RTV, LPV/r, TPV, DLV: Decrease clarithromycin dose in 

renal failure.

EFV, ATV: Consider alternative (e.g. azithromycin)

Erectile 

dysfunction

Sildenafil PIs + DLV: ≤ 25 mg q48 h

Vardenafil PIs + DLV: ≤ 2.5 mg/d

Tadalafil PIs + DLV: ≤ 10 mg q72 h
16 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Drug Table 7. – continued

Drug Interactions: Combinations with 

PIs or NNRTIs Requiring Dose Modifications

Class Agent ART

Antimycobacterials

Rifabutin 

FPV 1400 mg bid + RBT 150 mg/d or 300 mg 3x/wk

ATV 400 mg/d + RBT 150 mg qod or 150 mg 3x/wk

EFV 600 mg/d + RBT 450-600 mg/d or 600 mg 3x/wk 

IDV 1000 mg q 8h + RBT 150 mg/d or 300 mg 3x/wk

LPV/r 400/100 mg + RBT 150 mg qod or 3x/wk

NFV 1000 mg tid + RBT 150 mg/d or 300 mg 3x/wk

NVP standard + RBT standard

RTV 600 mg bid + RBT 150 mg qod or 150mg 3x/wk

RTV (maintain usual dose) + PI (standard dose) + 

RBT 150 mg qod or 3x/wk

Rifampin 

All PIs & NNRTIs contraindicated except EFV using 

standard doses of rifampin; consider EFV daily dose of 

800 mg qd

Lipid Lowering 

Lovastatin, 

Simvastatin Avoid PIs and DLV; no data for EFV and NVP

Atorvastatin 

Atorvastatin levels 480%–SQV/RTV, 70%–NFV, 9x–TPV, 

150%–FPV, 590%–LPV/r; 43% EFV; 

No data–IDV, ATV, NVP

Pravastatin Levels pravastatin 33%–LPV/r, 50% SQV/RTV; 

No data for other PIs or NNRTIs

Miscellaneous 

Theophylline RTV: Monitor theophylline levels

Warfarin RTV, DLV, EFV: Monitor INR closely if given with any PI or 

NNRTI

Trazedone RTV: lowest dose + monitor CNS signs

Desipramine RTV: Consider desipramine dose reduction

Grapefruit juice IDV , SQV

Ca channel 

blockers

ATV, FPV, RTV: contraindicated 

Others: dose titration of 

Ca channel blockers + EKG monitoring

Diltiazem All PIs: Reduce diltiazem dose 50% + monitor EKG

ABC 

Antacids

TPV ABC levels 35–45%; ABC dose? 

ATV and TPV levels ; give PI 2 hrs before or 1 hr after

PPI ATV: Avoid PPI
U.S. Department of Health and Human Services 17

Antiretroviral Therapy

Adult ART Table 1. 

When to Start Therapy*

Clinical Category CD4+ Count Viral Load Recommendation

Symptomatic (AIDS or 

severe symptoms) Any value Any value Treat

Asymptomatic, AIDS CD4+ < 200/mm3 Any value Treat

Asymptomatic CD4+ > 200/mm3

but < 350/mm3 Any value 

Offer treatment, 

but consider patient 

readiness, probability 

of adherence, potential 

side effects, and 

prognosis based on 

CD4 count, CD4 slope, 

and HIV viral load

Asymptomatic CD4+ > 350/mm3 > 100,000 c/mL 

Consider therapy 

or observe (Data 

inconclusive for either 

alternative)

Asymptomatic CD4+ > 350/mm3 < 100,000 c/mL Defer therapy and 

observe

* There are special considerations for pregnant women; consult Pregnancy Tables 1-3

Adult ART Table 2. 

Suggested Minimum Target Trough Levels

Drug Concentration

APV 400 mg/mL

IDV 100 mg/mL

LPV 1000 mg/mL

NFV 800 mg/mL

RTV 2100 mg/mL

SQV 100-250 mg/mL

EFV 1000 mg/mL

NVP 3400 mg/mL
18 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult ART Table 3. 

Starting Regimens for Antiretroviral Naïve Patients

NRTI-Based Regimens # of pills per day

Preferred Regimens 

efavirenz + (lamivudine or emtricitabine) + 

(zidovudine or tenofovir DF) – except for pregnant 

women or women with pregnancy potential

2–3

Alternative Regimens 

• efavirenz + (lamivudine or emtricitabine) + 

(didanosine or stavudine or abacavir) - except 

for pregnant women or women with pregnancy 

potential

2–4

• nevirapine + (lamivudine or emtracitabine) 

+(zidovudine or abacavir or tenofovir or 

stavudine* or didanosine) (Avoid in women 

with baseline CD4>250 and men with baseline 

CD4 > 400)

3–6

PI-Based Regimens # of pills per day

Preferred Regimens lopinavir/ritonavir + (lamivudine or emtricitabine) 

+ zidovudine 6–7

Alternative Regimens 

• atazanavir + (lamivudine or emtricitabine) 

+ (zidovudine or stavudine* or abacavir or 

didanosine) or (tenofovir + ritonavir)

3–6

• fosamprenavir + (lamivudine or emtricitabine) + 

(zidovudine or stavudine* or abacavir or tenofovir 

or didanosine)

5–8

• fosamprenavir/ritonavir + (lamivudine or 

emtricitabine) + (zidovudine or tenofovir or 

didanosine or stavudine* or abacavir)

5–8

• indinavir + ritonavir† + (lamivudine or 

emtricitabine) + (zidovudine or tenofovir or 

didanosine or stavudine* or abacavir)

7–12

• nelfinavir + (lamivudine or emtricitabine) 

+ (zidovudine or stavudine* or tenofovir or 

didanosine or abacavir)

5–8

• saquinavir (Invirase) + ritonavir + (lamivudine 

or emtricitabine) + (zidovudine or stavudine* or 

tenofovir or didanosine or abacavir)

7-15

• lopinavir/ritonavir + (lamivudine or emtricitabine) 

+ (stavudine* or abacavir or tenofovir or 

didanosine)

5-7

Triple NRTI Regimen – 

As Alternative to PI- or NNRTI-based regimens # of pills per day

Alternative Regimens • abacavir + lamivudine + zidovudine 2

* Stavudine is associated with higher rates of lipoatrophy and mitochondrial toxicity than other NRTIs

† Low-dose (100-400 mg) ritonavir
U.S. Department of Health and Human Services 19

Adult ART Table 4. 

Advantages and Disadvantages of Antiretroviral Regimens

Advantages Disadvantages

NNRTIs

Class– less lipodystrophy

Save PI option

Extensive experience

Low genetic barrier to resistance

Class resistance / Drug interactions

High rate of rash reactions

EFV

Potent

Low pill burden qd

Once daily dosing 

CNS toxicity

Teratogenic in first trimester

NVP Extensive experience in pregnancy

No food effect

ADR: hepatotoxicity + rash

Contraindicated in women with baseline CD4 

count >250

PI Class– extensive experience

Save NNRTI option

ADR– lipodystrophy

Multiple drug interactions

GI intolerance

ATV

Once daily dosing

Low pill burden

No hyperlipidemia

ADR: Jaundice + PR interval prolongation

Drug interaction with TDF and EFV

LPV/r Potency

Coformulated with RTV

ADR: GI intolerance

Reduced levels in pregnancy

FPV/r

Low pill burden

No food effect

Once daily dosing

ADR: skin rash

IDV/r No food requirement

bid dosing with RTV boosting

ADR: Nephrolithisis

Requirement for po fluid

NFV Substantial experience in pregnancy

ADR: diarrhea

High rate virologic failure

Food requirement

SQV/r Improved GI tolerance with Invirase ADR: GI intolerance

NRTIs

AZT/ 3TC/ ABC

Coformulated

No food effect

Preserves PI and NNRTI options

Higher rate of virologic failure if used alone

ADR: ABC hypersensitivity

NRTI pairs

AZT/ 3TC*

Extensive experience

Coformulated

No food effect

ADR: GI intolerance + narrow suppression 

(AZT)

HBV flare when 3TC stopped

d4T/ 3TC* No food effect

Once daily

ADR of d4T **

HBV flare when 3TC stopped

TDF/ 3TC* or 

FTC

Well tolerated

Once daily 

TDF + FTC coformulated

HBV flare when TDF, 3TC, or FTC stopped

ddI/ 3TC* Once daily

ADR: ddI**

Food effect

HBV flare when 3TC stopped

ABC/ 3TC*

Once daily

No food effect

Coformulated

ADR: ABC hypersensitivity

HBV flare when 3TC stopped

* FTC is similar to 3TC; has longer intracellular half life and has less extensive experience

** ADRs- d4T lipoatrophy, lactic acidosis, peripheral neuropathy; ddI- peripheral neuropathy, pancreatitis 

and lactic acidosis
20 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult ART Table 5. 

Antiretroviral Regimens or Components That Are 

Not Generally Recommended

Rationale Exception

Antiretroviral Regimens Not Recommended

Monotherapy 

• Rapid development of resistance

• Inferior antiretroviral activity when 

compared to combination with three or 

more antiretrovirals

Pregnant women with 

HIV-RNA <1,000 

copies/mL using 

zidovudine monotherapy 

for prevention 

of perinatal HIV 

transmission

Two-agent drug 

combinations

• Rapid development of resistance

• Inferior antiretroviral activity when 

compared to combination with three or 

more antiretrovirals

For patients currently on 

this treatment, it may be 

reasonable to continue 

if virologic goals are 

achieved

ABC + TDF + 3TC as a 

triple NRTI regimen High rate of virologic failure and resistance No exception

TDF + ddI + 3TC High rate of virologic failure and resistance No exception

TDF + ddI + NNRTI High rate of virologic failure

Possible reduced CD4 response No exception

Antiretroviral Components Not Recommended As Part of 

Antiretroviral Regimen

Saquinavir hard gel 

capsule (Invirase) as 

single PI

• Poor oral bioavailability (4%)

• Inferior antiretroviral activity when 

compared to other protease inhibitors

No exception

d4T + ddI Reports of serious, even fatal, cases of lactic 

acidosis with hepatic steatosis 

When no other 

antiretroviral options 

are available and 

potential benefits 

outweigh the risks*

ATV + IDV Potential for additive hyperbilirubinemia No exception

FTC + 3TC No potential benefit No exception

Efavirenz in pregnancy Teratogenic in nonhuman primate 

When no other 

antiretroviral options 

are available and 

potential benefits 

outweigh the risks*
U.S. Department of Health and Human Services 21

Adult ART Table 5. – continued

Antiretroviral Regimens or Components That Are 

Not Generally Recommended

Rationale Exception

Antiretroviral Components Not Recommended As Part of 

Antiretroviral Regimen (continued)

Amprenavir oral 

solution in: 

• pregnant women

• children <4 yr old

• patients with renal or 

hepatic failure

• patients treated with 

metronidazole or 

disulfiram

Oral liquid contains large amount of the 

excipient propylene glycol, which may be 

toxic in the patients at risk

No exception

d4T + ZDV Antagonistic No exception

ddC + d4T or 

ddC + ddI Additive peripheral neuropathy No exception

ATV + IDV Additive hyperbilirubinemia No exception

FTC + 3TC Similar agents; no potential benefit No exception

Hydroxyurea 

• Decreases CD4 count

• Augments d4T- and ddI-associated side 

effects, such as pancreatitis & peripheral 

neuropathy

• Inconsistent evidence of improved viral 

suppression

• Contraindicated in pregnancy (Pregnancy 

Category D)

No exception

Not Recommended As Part of Initial Antiretroviral Regimen

DLV Modest antiretroviral effect *

RTV as single PI GI intolerance *

d4T + ddI Increased peripheral neuropathy, lactic 

acidosis, and pancreatitis *

NFV + SQV High pill burden of 16-22 caps/day *

TPV Tested and approved only for salvage *

* Reasonable to use in unusual circumstances
22 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult ART Table 6. 

Laboratory Monitoring

• Baseline tests, CBC, chemistry profile including liver and renal 

function tests, PAP smear for female patients, Toxoplasma gondii IgG, 

VDRL (or RPR), anti-HCV, anti-HBc, and PPD (if no prior positive, see 

TB tables)

• Confirm HIV Ab+ if not documented

• Viral load at baseline (x2) and 2-8 wks after initiating therapy or 

new regimen, then every 3-4 months, clinical event, or significant 

(3x or >0.5 log10 c/mL) change in VL

• CD4 count at baseline and then every 3-6 months

• Antiretroviral agent toxicity (see Drug Table 2, pg 8)

• Resistance tests

Recommended

- Virologic failure within 4 weeks of stopping ART

- Suboptimal suppression

- Acute HIV infection 

Consider

- Chronic HIV infection, before therapy

Not Usually Recommended

- After discontinuation of drugs for more than 4 weeks

- Viral load <1,000 c/mL
U.S. Department of Health and Human Services 23

Adult ART Table 7. 

Resistance Mutations*

Drug Major † Minor †

Protease Inhibitors

IDV 46 IL, 82 AFT, 84 V 10 IRV, 20 MR, 24 I, 32 I, 36 I, 54 V, 

71 VI, 73 SA, 77 I, 90 M

NFV 30 N, 90 M 10 FI, 36 I, 46 IL, 71 VL, 77 I, 82 

AFTS, 84 V, 88 DS

RTV 82 AFTS, 84 V 10 FIRV, 20 MR, 32 I, 33 F, 36 I, 46 IL, 

50 V, 54 VL, 71 VT, 77 T, 90 M

SQV 48 V, 90 M 10 IRV, 54 VL, 71 VT, 73 S, 77 I, 82 

A, 84 V

FPV 50 V, 84 V 10 FIRV, 32 I, 46 IL, 47 V, 54 LVM, 73 

S, 82 AFST,90 M

LPV/r 32 I, 47 VA, 82 AFTS

10 FIVR, 20 MR, 24 I, 31 I, 33 F, 46 

IL, 50 V, 53 L, 54 VLAMTS, 63 P, 71 

VT, 73 S, 90 M

ATV 50 L, 84 V, 88 S

10 IFV, 16 E, 20 RMI, 24 I, 32 I, 33 

IFV, 36 ILV, 46 I, 48 V, 54 LVMT, 60 

E, 62 V, 71 VITL, 73 CSTA, 82 A, 90 

M, 93 L

TPV 33 I, 82 LT, 84 V

10 IV, 13 V, 20 MR, 35 G, 36 I, 43 T, 

46 L, 47 V, 54 AMV, 58 E, 69 K, 74 P, 

83 D, 90 M, 46 I, 54 V

* Adapted from IAS-USA Topics HIV Med 2005; 13:125. See http://www.iasusa.org

† Major: usually develop first; associated with decreased drug binding; Minor: also contribute 

to drug resistance; may affect drug binding in vitro less than primary mutations. Use of Major

and Minor designations for NRTIs and NNRTIs has been suspended.
24 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult ART Table 7. – continued

Resistance Mutations*

Drug Codon Mutations

Nucleosides and Nucleotides

AZT 41 L, 44 D, 67 N, 70 R, 118 I, 210 W, 215 YF, 219 Q

d4T 41 L, 44 D, 65 R, 67 N, 70 R, 118 I, 210 W, 215 YF, 219 QE

3TC 65 R, 184 VI

FTC 65 R, 184 VI

ddI 65 R, 74 V

ABC 65 R, 74 V, 115 F, 184 V

TDF 65 R

Multinucleoside A- Q 151 M 62 V, 75 I, 77 L, 116 Y, 151 M

Multinucleoside B 69 insertion 41 L, 67 N, 69 insert, 70 R, 210 W, 215 YF, 219 QE

Multinucleoside TAMS 41 L, 67 N, 70 R, 210 W, 215 YF, 219 QE

NNRTIs

NVP 100 I, 103 N, 106 AM, 108 I, 181 CI, 188 CLH, 190 A

DLV 103 N, 106 M, 181 C, 188 L, 236 L

EFV 100 I, 103 N, 106 M, 108 I, 181 CI, 188 L, 190 SA, 225 H

Multi-NNRTI resistance 103 N, 106 M, 188 L

Multi-NNRTI resistanceaccumulation 100 I, 106 A, 181 CI, 190 SA, 230 L

* Adapted from IAS-USA Topics HIV Med 2005; 13:125. See http://www.iasusa.org
U.S. Department of Health and Human Services 25

Therapeutic Failure

Definitions

Virologic Failure:

• Failure to achieve VL <400 c/mL by 24 wks or <50 c/mL by 48 

wks. Note: Most patients will have a decrease in VL of ≥1 log10 c/mL 

at 1–4 weeks

• Viral suppression followed by repeated positive viral load

Immunologic Failure:

Failure to increase CD4 count 25-50 cells/mm3 during first year 

Note: Mean increase is about 150 cells/mm3 in a year with HAART in 

treatment naïve patients

Clinical Failure: 

Occurrence or recurrence of HIV-related event ≥ 3 months after start 

of HAART 

Note: Must exclude immune reconstitution syndromes

Management of Regimen Failure

Assessment

• Adherence: Address cause and/or simplify regimen

• Tolerability

- Change one drug within class

- Change classes; e.g. PI-based HAART vs NNRTI-based HAART

• Pharmacokinetic Issues
26 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Therapeutic Failure – continued

Virologic Failure

Definition: 

1) HIV RNA > 400 c/mL (VL) after 24 weeks of treatment 

2) VL > 50 c/mL after 48 weeks of treatment 

3) Viral load detectable after achieving undetectable (viral rebound) VL 

indicating failure should be confirmed; “Blips” (isolated VL values of 

50–1,000 c/mL) do not constitute failure if unconfirmed

Assessment:

• Review treatment history and prior resistance tests

• Access adherence, intolerance and pharmacokinetic issues (food/

fasting requirements, drug interactions, malabsorption)

• Distinguish between limited, intermediate, and extensive prior 

treatment and drug resistance

• The viral load that defines an indication for therapeutic intervention 

is in the range of 400–5000 c/mL; The threshold of 400 may result 

in multiple drug exposures and limited access to resistance tests 

(since a threshold of 1000 c/mL is often required to do the test); a 

delay to a threshold of 5000 c/mL risks accumulation of multiple 

resistance mutations including class resistance

• Perform resistance tests while the patient is receiving the failed 

regimen or within 4 weeks of stopping it

• Identify 2–3 active drugs for the next regimen; two active drugs are 

essential for viral supression

• If no resistance is demonstrated: consider continuation with 

emphasis on adherence, possibly with therapeutic drug monitoring

• With low level viremia (< 5000 c/mL) and limited drug exposure 

consider boosting a PI, or intensification by adding a nucleoside or 

change therapy

• With intermediate or extensive prior drug exposure, consider 

an agent with a new mechanism of action (enfuvertide) usually 

combined with a PI including TPV or an experimental drug such 

as TMC 114

• With extensive treatment failures, multiple resistance mutations and 

no available regimens likely to achieve virologic goals: the goal of 

therapy is to preserve immune function and avoid HIV-associated 

complications; HIV therapy should be continued
U.S. Department of Health and Human Services 27

Adult ART Table 8.

Methods to Achieve Readiness to Start HAART 

& Maintain Adherence

Patient-related

• Negotiate a plan or regimen that the patient understands and to 

which she or he commits

• Take time needed, >2 visits, to ensure readiness before 1st prescription

• Recruit family, friends, peer and community support

• Use memory aids: timers, pagers, written schedule, pill boxes/

medication organizers

• Plan ahead: keep extra meds in key locations, obtain refills

• Use missed doses as opportunities to prevent future misses

• Active drug and alcohol use and mental illness predict poor adherence; 

race, sex, age, educational level, income, and past drug use do not

Provider/Health Team-related

• Educate patient re: goals of therapy, pills, food effects, and 

side effects

• Assess adherence potential before HAART; monitor at each visit

• Ensure access at off-hours and weekends for answering questions 

or addressing problems

• Utilize full health care team; ensure med refills at pharmacy

• Consider impact of new diagnoses and events on adherence

• Provide training updates on adherence for all team members 

and utilize team to reinforce adherence

• Monitor adherence and intensify management in periods of 

low adherence

• Educate volunteers, patient-community representatives

Regimen-related

• Avoid adverse drug interactions

• Simplify regimen re: dose frequency, pill burden, 

and food requirements

• Inform patient about side effects

• Anticipate and treat side effects
28 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult ART Table 9. 

National Cholesterol Education Program: 

Indications for Dietary or Drug Therapy for Hyperlipidemia

Coronary Heart 

Disease Risk 

Status

Goal Threshold for 

Diet Rx

Threshold for 

Drug Rx

No CHD & 0-1 Risks* LDL <160 mg/dL LDL ≥160 mg/dL 

LDL >190 mg/dL (LDL 

160-190 Drug therapy 

optional)

No CHD & ≥ 2 Risks* LDL <100 mg/dL LDL ≥130 mg/dL 

10 Yr CHD Risk 

<10% ‡

LDL > 160 mg/dL

10 Yr CHD Risk 10-

20% ‡

LDL >130 mg/dL

CHD or CHD 

equivalent:

• Clinical ASCVD †

• Diabetes mellitus

• Multiple Risk Factors 

conferring 10 Yr risk 

of CHD of >20% ‡

LDL < 70 mg/dL LDL ≥100 mg/dL 

LDL >130 mg/dL 

(100-129 mg/dL: drug 

optional)

Triglycerides are an independent consideration

 • For patients with serum triglycerides >500 mg/dL the primary goal is reduction of triglycerides 

to prevent pancreatitis and reduce risk of CHD

• For patients with serum triglycerides 200 - 499 mg/dL reduction of non-HDL cholesterol 

becomes a secondary goal after reaching LDL goal

Adapted from: JAMA 2001; 285:2486-2497; updated NCEP – Circulation 2004; 110:227.

Editors Note: This table is a basic condensation of complex guidelines. Readers are encouraged 

to consult and use the tools available on the NHLBI web site: http://www.nhlbi.nih.gov/

guidelines/cholesterol/

* CHD Risk Factors: Age (men >45 years; women >55 yrs or premature menopause without 

estrogen replacement); hypertension, current smoking, history of cardiovascular disease in first 

degree relative (<55 years for male relative and <65 years for female relative), or serum HDL 

cholesterol <40 mg/dL. If high HDL (>60 mg/dL) subtract one risk factor.

† Atherosclerotic cardiovascular disease (ASCVD) includes peripheral artery disease, symptomatic 

carotid artery disease, and abdominal aortic aneurysm.

‡ Calculation of 10 year risk of CHD requires tables which may be found in the JAMA 

2001;285:2486 or the NHLBI website: http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm
U.S. Department of Health and Human Services 29

Adult ART Table 10. 

Drug Therapy for Hyperlipidemia 

(Recommendations of the ACTG [Dube MP et al, CID 2000; 31:1216])

Lipid Problem Preferred Alternative Comment

Isolated high LDL Statin* Fibrate† 

Start low doses and 

titrate up; with PIs 

watch for myopathy 

High cholesterol and 

triglycerides Statin* or fibrate† Start one and add other

Combination may 

increase risk of 

myopathy

Isolated high 

triglycerides Fibrate† Statin* 

Combination may 

increase risk of 

myopathy

NOTE:

Optimal management of hyperlipidemia should begin with specific risk factor reduction 

interventions such as: low-fat diet; regular exercise; moderation of alcohol intake; smoking 

cessation, blood pressure control, and diabetes control (where applicable). The likelihood of 

success with drug therapy for hyperlipidemia is substantially reduced in the absence of such 

interventions.

* Statin: Pravastatin 20 mg/day (max. 40 mg/day), fluvastatin 20-40 mg/day, or atorvastatin 

10 mg/day. Use particular caution when giving LPV/r or NFV with Atorvastatin; also 

see Table 5. Drug Interactions: Contraindicated Combinations.

† Fibrate: Gemfibrozil 600 mg bid ≥ 30 minutes before meal or Fenofibrate tablets (e.g. Tricor) 

160 mg qd Micronized fenofibrate (capsules) 67mg qd to start, max. dose 201 mg qd
30 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Pregnancy and HIV

Antiretroviral Therapy in Pregnancy

Continually updated recommendations: 

 US Department of Health and Human Services. Public Health 

Service Task Force Recommendations for Use of Antiretroviral 

Drugs in Pregnant HIV-1-Infected Women for Maternal Health and 

Interventions to Reduce Perinatal HIV Transmission in the U.S.

November 17, 2005. Available at: http://aidsinfo.nih.gov.

Recommendation for antiretroviral drugs in pregnancy:

 All pregnant women with HIV infection should be treated.

Goal of therapy: 

 VL < 1000 c/mL

Regimen:

 See Pregnancy Table 1

Pregnancy Table 1. 

Preferred Antiretroviral Agents

NRTI Class

• Preferred: AZT/3TC

• Alternates: ddI, FTC, d4T, ABC

• Insufficient data: TDF

• Not recommended: ddC

NNRTI Class

• Preferred: NVP (if baseline CD4 is < 250/mm3)

• Not recommended: EFV and DLV

PI Class

• Recommended: NFV (1250 mg bid), SQV/r (1000/100 mg bid)

• Alternatives: IDV, LPV/r, RTV

• Insufficient data: APV, FPV, ATV, TPV

Entry Inhibitor Class

• Insufficient data: ENF
U.S. Department of Health and Human Services 31

Pregnancy Table 2. 

Antiretroviral Agents: Pharmacokinetic and Toxicity Data*

Agent FDA cat.** Experience in Pregnancy

Nucleoside/nucleotide reverse transcriptase inhibitors

ABC C No studies; concern for hypersensitivity

ddI B Well tolerated; usual pharmacokinetics; concern for lactic acidosis; 

avoid ddI + d4T

FTC B No studies

3TC C Well tolerated; usual pharmacokinetics

d4T C Well tolerated; usual pharmacokinetics; concern for lactic acidosis; 

avoid ddI + d4T

TDF B No studies; animal studies show bone abnormalties

ddC C No studies; teratogenic in animals 

ZDV C Well tolerated; preferred agent

Non-nucleoside reverse transcriptase inhibitor

DLV C No studies

EFV D Teratogenic; 4/142 birth defects; avoid in 1st trimester

NFV C Well tolerated; contraindicated as initial Rx with CD4 > 250; single 

dose with labor causes high rates of resistance

Protease inhibitors

APV C No studies; oral solution is contraindicated

ATV B No studies; theoretical concern for elevated indirect bilirubin

FPV C No studies

IDV C Low levels and theoretical concern for elevated indirect bilirubin

LPV/r C No studies

NFV B Well tolerated; extensive experience; use 1250 mg bid

RTV B No studies

SQV B Levels are low: use SQV: RTV 800/100 mg bid or 1000/100 mg bid

TPV C No studies

* June 23, 2005

** Pregnancy categories: A=Controlled studies show no risk

B=No evidence of risk in humans 

C=Risk cannot be excluded

D=Positive evidence of risk
32 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Pregnancy Table 3. 

Antiretroviral Drugs for Delivery

A. ACTG 076 Protocol (Should be used as part of ART regimen in all 

pregnant women, if possible)

Antepartum: AZT 300 bid or 200 tid po, wk 14 until delivery

Intrapartum: AZT IV 2 mg/kg over first hr then 1 mg/kg/hr until delivery

Postpartum: (Infant): AZT syrup 2 mg/kg po q 6h (or 1.5 mg/kg q 6h IV) x 6 wks

B. Regimen for 2nd & 3rd Trimesters

Standard ART, but:

• Include AZT * according to 076 protocol

• Treat based upon maternal clinical/immunologic status but avoid: EFV, HU, AZT & d4T, d4T & 

ddI, APV solution

• Previously untreated pregnant women with VL <1000 c/mL and CD4 >350 cells/mm3 may be 

treated with AZT monotherapy, AZT + 3TC, or HAART

C. Choices for Untreated Women Presenting In Labor and Their Infants

NVP: 200 mg po onset labor; Infant: single 2 mg/kg po at 48-72 hrs

AZT: 600 mg po onset labor and 300 mg po q3h until delivery PLUS 3TC 150 mg po onset labor 

and 150 mg po q12h until delivery; Infant: AZT 4mg/kg po q12h PLUS 3TC 2mg/kg po q12h 

for 7 days

AZT: 2mg/kg IV bolus then 1mg/kg/hr IV infusion until delivery; Infant: AZT 2mg/kg po q6h for 

6 wk (ACTG 076 Protocol)

NVP + AZT: NVP:200 mg po onset labor PLUS AZT 2mg/kg IV bolus then 1 mg/kg/hr IV infusion 

until delivery; Infant: NVP single 2 mg/kg po at 48-72 hrs PLUS AZT 2mg/kg po q6h for 6 wk

* Unless unacceptable side effects or toxicity or requires d4T-containing regimen

** AZT & d4T: pharmacologic antagonism; do not use together. APV oral solution (only) is 

contraindicated in pregnancy because it contains large quantities of propylene glycol, which 

cannot be metabolized in pregnancy. d4T & ddI: concerns about lactic acidosis; use only when 

other NRTIs have failed or caused unacceptable side effects/toxicity (New Engl J Med 1999; 

340:1723). EFV, HU: concerns about teratogenicity or birth defects; EFV: avoid in pregnancy.

Drug Information 

A listing of antiretroviral drugs with information pertinent to their use in pregnancy may be found 

in Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in 

Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal 

HIV-1 Transmission in the United States, Table 3.
U.S. Department of Health and Human Services 33

Pregnancy Table 4. 

Pregnancy Issues

Adverse Drug Reactions (ADR)

Generally, pregnant women are at the same risk of ADRs as non-pregnant individuals, but some 

ADRs may be more common because of pregnancy-related physiologic changes: anemia (iron & 

folate deficiency), nausea & vomiting (esp in 1st trimester), amniotransferase elevation. PIs may 

exacerbate pregnancy-related risk of hyperglycemia and NRTIs (especially d4T/ddI) increase risk 

of lactic acidosis.

Risk for Perinatal HIV Transmission

Viral load in plasma & genital tract (most significant), primary infection or late stage HIV, low 

CD4 count, STDs/other co-infections, pre-term delivery, increasing duration of membrane 

rupture, placental disruption, invasive fetal monitoring or assessment, vaginal delivery, and lack 

of AZT prophylaxis. 

Post-Partum Risk

Breast feeding: not recommended in U.S.

Pregnancy Table 5. 

Clinical Scenarios and Management of 

Untreated Pregnant Patients Including C-Section

Scenario 1: No prior ART

• Standard lab and clinical care

• HAART for VL > 1000 c/mL

• Include the 3–part 076 protocol (see Pregnancy Table 3A)

• Consider delay initial therapy until after 1st trimester

Scenario 2: Currently receiving ART

• Continue therapy, but include AZT according to 076 protocol (see Pregnancy Table 3A)

• Option to stop in 1st trimester 

Scenario 3: Woman in labor no prior therapy—options are:

• Intrapartum AZT and 6–week course for neonate

• AZT/3TC during labor and 3 weeks for neonate

• Single dose NVP intrapartum and single dose for infant

• Two–dose NVP and intrapartum AZT and 6 weeks AZT for newborn

Scenario 4: Woman has delivered

• Discuss HIV detection and implications

• Offer AZT to infant

• The mother should be evaluated for HIV management 
34 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Pregnancy Table 6. 

Clinical Scenarios and Management of 

Treated Pregnant Patients Including C-Section

Time of 

Presentation Recommended Management

Early In Pregnancy 

(<36 Weeks)

• Continue ART with standard monitoring, but:

o May consider discontinuation during 1st trimester: all drugs 

should be stopped and restarted simultaneously to reduce risk of 

resistance

o Include AZT if tolerated; see cautions for antiretrovirals, 

Pregnancy Table 3 footnotes

Late In Pregnancy 

(≥ 36 Weeks)

• Continue antiretroviral therapy including AZT without interruption 

during labor and delivery

• VL >1,000 copies/mL: Counsel that C-section is likely to reduce the 

risk of transmission to infant, but counsel about risks and benefits of 

all choices

C-Section Planned But 

Presents in Labor or With 

Ruptured Membranes

• Initiate ACTG 076 Protocol, Intrapartum in Pregnancy Table 3A

• Rapid progression of labor: vaginal delivery

• If long labor anticipated: consider C-section after loading dose of 

AZT or give pitocin to expedite delivery

Pregnancy Table 7. 

Delivery Procedures and Therapy

Procedure Therapy

Cesarean Section 

• Schedule for 38 wk

• If on ART, IV AZT starting 3 hrs before C-section and continue all 

other antiretroviral drugs with the exception of d4T

• Infant: Use ACTG 076 Protocol, Postpartum (infant) 

In Pregnancy Table 3A

Vaginal Delivery 

• If on ART give IV AZT with initiation of labor and continue all other 

antiretroviral drugs with the exception of d4T

• Avoid rupture of membranes, fetal scalp electrodes, forceps delivery, 

and vacuum extractor

• Infant: If TREATED mother, use ACTG 076 Protocol, Postpartum

(infant) in Pregnancy Table 3A

 If UNTREATED mother, use treatment from Pregnancy Table 3C

which matches maternal regimen

Antiretroviral Pregnancy Registry: www.APRegistry.com

1011 Ashes Dr, Wilmington NC 28405

Telephone: 800-258-4263

Fax: 800-800-1052
U.S. Department of Health and Human Services 35

Prevention of HIV for Providers in Three Steps

Step 1: Screen Patients for Risk Behaviors

• Behaviors and clinical factors associated with HIV, other STDs, and 

IV drug use (every visit)

• STD symptoms: most are asymptomatic (every visit)

• Pregnancy

• Screening tests

Patients Test

Routine

• All patients • Syphilis serology: RPR or VDRL*

• All women • Trichomonas wet mount or culture

• All women ≤ 25 years 

and sexually active • Cervical specimen for C. trachomatis

Consider

• All men and women not 

included above

• Screening for GC and C. trachomatis by 

urethral (men) or cervical (women) specimen 

or first catch urine for NAAT*

• Anal receptive sex • Anal swab for GC culture and, if available, 

for C. trachomatis

• Oral receptive sex • Pharyngeal culture for GC

• Possible pregnancy • Pregnancy test

* Repeat RPR or VDRL annually. Consider repeating screening tests for N. gonorrhea

and C. trachomatis annually or more frequently if sexually active, if screening 

previous test positive, or other high risk
36 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Step 2: Behavioral Interventions

• Prevention messages should be provided with each visit

• Communicate factors that influence transmission and risk 

reduction; i.e. abstinence, sex with condoms, sex exclusively with 

HIV-infected person(s). If sex with persons with unknown or 

negative serologic status, stress proper condom use.

• IDU

Stop using drugs

Enter substance abuse treatment

If patient continues to use drugs:

- Never reuse or share needles, water, or drug preparation 

equipment

- Use only syringes from reliable sources (pharmacies)

- Use new syringe; if not possible-boil or disinfect with bleach 

(http://www.cdcnpin.org)

- Use sterile water to prepare drugs; otherwise use tap water

- Use new or disinfected cooker and new cotton

- Clean injection site with new alcohol swab

- Safely dispose of needle

• Per act relative risks of HIV transmission

- Condom vs no condom: 1:20

- Compared to insertive vaginal sex: receptive vaginal sex 2:1, 

receptive anal sex 10:1, insertive fellatio 1:10, insertive anal 

sex 1.3:1, receptive fellatio 1:5 (STD 2002;29:38)

Note: Risks for condom use and acts are multiplicative; 

e.g, for the ratio for anal sex without a condom vs vaginal 

insertive sex with a condom is 100:1

• Viral load: each log10 reduction in viral load reduces probability of 

transmission 2.5 fold.

• Non-occupational postexposure prophylaxis: not endorsed by 

CDC due to “uncertain effectiveness.”

• HAART recipients: decreases in VL probably reduces but risk 

transgression in behavior eliminates this benefit; with structured 

treatment interruption, warn patient that viral load increases as 

does risk of transmission
U.S. Department of Health and Human Services 37

Step 3: Partner Counseling and Notification

• Laws: Follow local and state laws for reporting sex and 

needlesharing partners

• Initial Visit: Ask if all sex and needlesharing partners have been 

notified

• Follow-ups: Ask about new sex or needlesharing partners who 

have not been notified

• Referrals: All contacts should be referred to the Health 

Department; arrange for notification and testing without 

identifying source; patients who elect not to notify partners should 

be referred to the Health Department to conduct these activities
38 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Opportunistic Infections Adult OI Table 1. 2001 USPHS/IDSA Guidelines for Prevention of Opportunistic Infections Pathogen Episode Indication* First Choice Alternatives Comment Strongly Recommended P. carinii 10 & 20 Primary CD4 < 200 or CD4 % <14, thrush, hx AIDS defining illness or FUO Secondary Hx PCP unless immune reconstitution: see comment TMP-SMX 1 DS/d † or TMP-SMX 1 SS/d † Dapsone 100 mg/d or Dapsone 50 mg/d + pyrimethamine 50 mg/wk + leucovorin 25 mg/wk or Dapsone 200 mg + pyrimethamine 75 mg + leukovorin 25 mg/wk or Aerosol pentamidine 300 mg/mo or Atovaquone 1500 mg/d or TMP-SMX 1 DS† 3x /wk Immune reconstitution recommendations: Discontinue primary & secondary prophylaxis if CD4 >200 cells/mm3 for ≥ 3 mos Restart Prophylaxis: Restart prophylaxis if CD4 decreases to <200 cells/mm3 Tuberculosis See Adult OI Tables 2 and 3
U.S. Department of Health and Human Services 39 Toxoplasmosis 

10

+ anti-Toxoplasma lgG and CD4 <100 cells/mm3

TMP- SMX 1 DS † qd

TMP- SMX 1 SS† qd orDapsone 50 mg/d + pyrimethamine 50 mg/wk + Leucovorin 25 mg/wk orDapsone 200 mg/wk + pyrimethamine 75 mg/wk + Leucovorin 25 mg/wk orAtovaquone 1500 mg/d ± pyrimethamine 25 mg/d + Leucovorin 10 mg/d

Immune reconstitution recommendations:Discontinue if CD4 >200 cells/mm3for ≥ 3 mosRestart Prophylaxis:CD4 falls to <100-200 cells/mm3

20

Toxo tx unless immune reconstitution: see comment

Sulfadiazine 500-1000 mg qid +Pyrimethamine 25-50 mg/d +Leucovorin 10-25 mg/d

Clindamycin 300-450 mg q 6-8 hr + Pyrimethamine 25-50 mg/d+ Leucovorin 10-25 mg/d orAtovaquone 750 mg q 6-12 hr + Pyrimethamine 25 mg/d + Leucovorin 10 mg/d

Immune reconstitution recommendations:Discontinue if HAART 6-12 mos, CD4 >200 cells/mm3, and asymptomaticRestart Prophylaxis:CD4 falls to <200 cells/mm3

Mycobacterium avium complex 10 CD4 <50 cells/mm3

Azithromycin 1200 mg/wkClarithromycin 500mg bid

Rifabutin‡300 mg/d orAzithromycin 1200 mg / wk + Rifabutin‡ 300 mg/d

Immune reconstitution recommendations:Discontinue if CD4 >100 cells/mm3for ≥ 3 mo

20 Hx MAC disease 

Clarithromycin 500 mg bid +Ethambutol 15 mg/kg/d ±Rifabutin‡ § 300 mg/d

Azithromycin 500 mg/d +Ethambutol 15 mg/kg/d ±Rifabutin‡ 300 mg/d

Immune reconstitution recommendations:Discontinue if CD4 >100 cells/mm3 x >6 mo and Rx 12 mo and asymptomatic
40 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006 Adult OI Table 1. – continued 2001 USPHS/IDSA Guidelines for Prevention of Opportunistic Infections Pathogen Episode Indication* First Choice Alternatives Comment Varicella 10 Chickenpox /shingles exposure + susceptible (no history of disease and varicella seronegative) VZIG 5 vials (6.25 mL) IM <96 h post exposure Acyclovir has been removed from OI prophylaxis guidelines due to lack of documented efficacy Cryptococcosis 20 Hx Cryptococcal meningitis Fluconazole 200 mg po qd Amphotericin B 0.6-1.0 mg/kg iv qw-tiw or itraconazole 200 mg capsule po qd Immune reconstitution recommendations: Discontinue if CD4 >100 X 6 mo and completed initial Rx and asymptomatic Cytomegalovirus 20 Prior end-organ disease Extra ocular: ganciclovir 5 mg/kg/day IV 5-7 days/wk, valganciclovir 900 mg/d, or foscarnet 90mg/kg IV qd or cidofovir 5 mg/kg q 2 weeks For retinitis: ganciclovir sustained release implant q 6-9 months plus valganciclovir 900mg/d or ganciclovir or foscarnet (above doses) Cidofovir 5 mg/kg IV qow with probenecid 2 grams po 3 hours before the dose followed by 1 gram po 2 hours after the dose, and 1 gram po 8 hours after the dose (total of 4 grams) or Fomivirsen 1 vial (330μg) injected into the vitreous, then repeated every 2-4 wks ¶ or Valganciclovir 900 mg po qd Immune reconstitution recommendations: Discontinue if CD4 >100-150 X 6 mo + no active disease + negative ophthal exam
U.S. Department of Health and Human Services 41

Generally Recommended

S. pneumoniae 10 All Patients with CD4 > 200 Pneumovax None 

Immune reconstitution:Consider reimmunization if CD4 increases to >200 and initial immunization was given when CD4 <200

Hepatitis B 10 Susceptible- (anti-HBc negative) HBV vaccine series NoneInfluenza 10 All patients Influenza vaccine

Rimantidine 100 mg bidAmantadine 100 mg bidOseltamivir 75 mg qd

Hepatitis A 10

Susceptible- (antiHAV neg) and antiHCV positive Hepatitis A vaccine series None

* Indication is separately defined for:

10 = Primary: No prior infection with this pathogen20 = Secondary: Prior infection with this pathogen

† SS= Single strength tablet, DS=double strength tablet‡ Dose adjusted for concurrent PI/NNRTI§ Rifabutin reduces levels of clarithromycin by 50% (consider azithromycin if RBT is used)¶ Added Rx needed to protect the contralateral eye and other organ systems
42 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Tuberculosis and HIV

Latent TB and HIV Co-infection Candidates For Testing

• All HIV-infected patients without prior positive PPD test upon entry 

into HIV care

• Repeat testing annually for HIV-infected patients at risk of acquiring 

TB who have no prior positive tests

• All HIV-infected patients with prior negative skin test who are 

discovered to be contacts of pulmonary cases

Indications For Treatment of Latent Tuberculosis Infection 

(MMWR 2000;49 RR-6)

• Positive PPD (≥ 5 mm induration) plus no prior completed 

prophylaxis or treatment for TB disease

• Recent contact with TB case (Recent contacts who are initially TST 

negative should have TST repeated 12 weeks after last exposure to 

TB case; those placed on prophylaxis should be discontinued if PPD 

negative at 12 weeks)

• History of inadequately treated TB that healed

Patients meeting skin test positivity criteria should be 

evaluated to rule out active TB disease before initiating 

treatment
U.S. Department of Health and Human Services 43

Adult OI Table 2. 

Recommended Drug Regimens for Treatment of Latent TB in HIV Co-infected Adults

Regimen Adult Dosage (max) Criteria for Completion Comments

Preferred Regimens

All patients INH daily for 9 mos 300 mg qd + pyridoxine 50 mg qd 270 doses within 9 mos (up to 12 mos with interruptions)

INH may be administered concurrently with NRTIs, PIs, or NNRTIs; contact with provider monthly

INH twice-weekly for 9 mos 900 mg + pyridoxine 100 mg 2x/wk 76 doses within 9 mos (up to 12 mos with interruptions)

Acceptable alternative for HIV-infected adults; DOT must be used with twice weekly dosing

Alternative Regimen 

Contacts of isoniazid-resistant, rifampin-susceptible TB RIF daily for 4 mos† 

RIF 10 mg/kg (600 mg) RBT is alternative if patient is receiving HAART*

120 doses within 6 mos

8 week regimen: PZA + RIF 

No longer recommended due to excessive hepatotoxicity including 7 deaths (not in persons known to have HIV co-infection) MMWR2003;52:735

Abbreviations: INH = isoniazid, RIF = rifampin, RBT= rifabutin, PZA = pyrazinamide, DOT = 

directly observed therapy

* See Drug Table 7 for RBT & PI/NNRTI dose adjustments† May not be used with patients taking PI/NNRTI with the exception of RTV/SQV, RTV, or EFV
44 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult OI Table 3. 

Monitoring of Patients on Latent TB Prophylaxis

Latent TB Regimen Monitoring

All patients 

• Initial clinical evaluation

• Educate patients about side effects associated with LTBI treatment

• Advise to stop treatment and promptly seek medical evaluation if 

these occur

INH 

• Contact with patient monthly; LFTs at baseline and 3 mo* and 

with hepatitis sx

• Include careful questioning about side effects and a brief physical 

examination checking for evidence of hepatitis or other side 

effects

Rifampin or 

rifabutin + PZA

• Clinic visits at 2,4,6, & 8 wks; CBC & LFTs at baseline, 2,4, & 6 

wks or with symptoms†

• Include careful questioning about side effects and a brief physical 

examination checking for evidence of hepatitis or other side 

effects

* INH: D/C if ALT 5X ULN or symptoms plus ALT ≥ 3X ULN

† Rifampin/rifabutin + PZA: D/C if ALT ≥ 5X ULN or if symptoms plus any abnormal LFTs
U.S. Department of Health and Human Services 45

Special Considerations for TB Treatment with HIV Co-infection

Treatment of Tuberculosis Disease

 American Thoracic Society/Centers for Disease Control and 

Prevention/Infectious Diseases Society of America: Treatment 

of Tuberculosis Am J Respir Crit Care Med 2003;167(4):603

Special Treatment Notes

 PREGNANCY: INH regimens preferred for pregnant women. 

Some experts would use RIF plus PZA as alternate regimen in 

HlV-infected pregnant women. PZA should be avoided during 

first trimester.

MDR-TB Exposure

 Expert consultation is recommended for persons who are likely 

to be infected with INH and RIF (multidrug) resistant-TB and at 

high risk of reactivation.

ART/TB Treatment Interactions

* Rifabutin should not be used with hard-gel saquinavir (as sole PI) 

or delavirdine.

Rifampin/Rifabutin 

 See Drug Table 7

Identical for General Population Except:

• CD4 <100/mm3: Continuation phase should be daily or 3x/week; once weekly 

rifapentine regimen should not be used

• Positive cultures at 2 months: “Strongly consider” 7 month continuation phase 

(total 9 mo)

• In absence of prior HIV therapy and CD4 < 350/mm3: delay antiretroviral drugs 

for 4-8 weeks

• RIF may be used with 2 NRTIs + EFV, RTV + SQV (Invirase or Fortovase) or 

AZT/3TC/ABC

• Rifabutin combined with other PIs and NNRTI requires dose adjustment of both;

See: www.cdc.gov/nchstp/tb/ or www.medscape.com/updates/quickguide

• When starting NNRTI or PI in patient receiving RIF, substitute rifabutin 2 weeks prior 

to NNRTI or PI to give a 2 week washout period for RIF

• Paradoxical reaction: Frequency is 7-36%; clinical features: high fever, increased 

adenopathy, CNS lesions, pulmonary infiltrates and pleural effusions; treatment: 

symptomatic; if severe give prednisone 1 mg/kg and reduce dose at 1-2 weeks
46 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult OI Table 4. 

Treatment of Drug-Susceptible TB

Drugs Phase 1 (8 weeks) Phase 2*: regimen, doses, 

minimal duration

INH

RIF

PZA

EMB

8 weeks

• 7 d/wk for 8 wks (56 doses) or

• 5 d/wk for 8 wks (40 doses)

• INH/RIF 7 d/wk for 18 weeks (126 doses) or

• INH/RIF 5 d/wk for 18 weeks (90 doses) or

• INH/RIF 2x/wk for 18 weeks ( 36 doses)

INH

RIF

PZA

EMB

2 wk/6 week

7 d/wk, for 2 wks (14 doses), then 

2x/week for 6 wks (12 doses)

INH/RIF 2x/wk for 18 weeks (36 doses)

INH

RIF

PZA

EMB

8 weeks

3 x/week for 8 weeks (24 doses) INH/RIF 3x/week for 18 weeks (54 doses)

INH

RIF

EMB

8 weeks

• 7 d/week for 8 wks (56 doses)

• 5 d/week for 8 wks (40 doses)

• INH/RIF 7 d/week for 31 weeks (217 doses) 

or

• INH/RIF 5 d/wk for 31 weeks (155 doses) or

• INH/RIF 2x/wk for 31 weeks (62 doses)

INH = isoniazide, RIF = rifampin, RPT = rifapentine, PZA = pyrazinamide, EMB = ethambutol

* Patients with cavitation at baseline and positive cultures at 2 months should receive 31 week 

continuation phase for total of 9 months
U.S. Department of Health and Human Services 47

Adult OI Table 5. 

Doses of Antituberculosis Drugs – First-line Drugs

Drug Daily l/wk 2x/wk 3x/wk

INH 5 mg/kg (300)* 15 mg/kg (900) 15 mg/kg (900) 15 mg/kg (900)

RIF 10 mg/kg (600) - 10 mg/kg (600) 10 mg/kg (600)

RPT - - 10 mg/kg (600) -

PZA (wt)

40-55 kg

56-75 kg

76-90 kg

1 gm

1.5 gm

2.0 gm

-

-

-

2.0 gm

3.0 gm

4.0 gm

1.5 gm

2.5 gm

3.0 gm

EMB (wt)

40-55 kg

56-75 kg

76-90 kg

800 mg

1200 mg

1600 mg

-

-

-

2000 mg

2800 mg

4000 mg

1200 mg

2000 mg

2400 mg

*Dose in mg/kg and (usual dose in mg)
48 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult OI Table 6. 

Management of Opportunistic Infections

(MMWR 2004; 53 RR 15)

Bartonella: Treat ≥ 3 mo

• Preferred: erythromycin 500 mg qid po or IV or doxycycline 100 mg bid po or IV x ≥ 3 mo

• Alternative: azithromycin 600 mg/d po or clarithromycin 500 mg bid po x ≥ 3 mo

• Note: If relapse: treat lifelong; CNS: Use IV or po doxycycline

Candida Thrush: Treat 7–14 days

• Preferred: clotrimazole troches 10 mg po 5x/d or Nystatin susp 5 mL qid or 

pastilles 4–5 x/d or fluconazole 100 mg po/d; all 7–14 days

• Fluconazole–refractory: Itraconazole oral solution ≥ 200 mg/d po or 

amphotericin B 0.3 mg/kg/d IV

• Recurrent disease: Consider chronic fluconazole or itraconazole

Candida Esophagitis: Treat 14–21 days

• Preferred: Fluconazole 100 mg/d (up to 400 mg/d) po or IV x 14–21 days

• Alternative: Itraconazole oral soln 200 mg/d, capsofungin 70 mg IV x 1, then 50 mg/d 

x 7 days or amphotericin B 0.3–0.7 mg/kg/d or voricomazole 200 mg/d po or IV or 

liposomal amphotericin 3–5 mg/kg/d

Candida Vaginitis: Treat 3–7 days

• Preferred: Topical azole (clotrimazole, butoconazole, miconazole, ticonazole, terconazole) 

x 3–7 days or topical nystatin or fluconazole 150 mg x 1 day or itraconazole 200 mg bid 

x 1 day or 200 mg/d x 3 days

• Recurrent: Daily topical azole

Cryptococcoisis: Treat lifetime unless immune reconstitution

• Acute phase: Amphotericin B 0.7 mg/kg/d IV + flucytosine 25 mg/kg qid po x 14 days

• Consolidation phase: Fluconazole 400 mg/d po x 8 weeks

• Chronic maintenance phase: Fluconazole 200 mg/d po until CD4 > 

100–200/mm3 x ≥ 6 mo

• Alternative — Acute phase: Amphotericin B 0.7 mg/kg/d x 14 days (without 5FC) or

fluconazole 400–800 mg po or IV qd ± flucytocine 25 mg/kg/ qid po

• Alternative — Consolidation phase: Itraconazole 200 mg bid po 

• Alternative — Chronic maintenance phase: Itraconazole 200 mg/d po until CD4 > 

100–200/mm3 x ≥ 6 mo

• Note: Drain CSF if OP > 200 mL H2O

Cryptosporidiosis

• Preferred: Symptomatic treatment + HAART

• Alternatives: Nitazoxanide 500 mg po bid or paromomycin 25–35 mg/kg/d in 2–3 doses
U.S. Department of Health and Human Services 49

Adult OI Table 6. – continued

Management of Opportunistic Infections

(MMWR 2004; 53 RR 15)

Cytomegalovirus retinitis

• Immediate sight-threatening lesions: Intraocular implant + valganciclovir 900 mg/d po

• Peripheral lesions: Valganciclovir 900 mg bid po x 14–21 days, then 900 mg/d

• Alternative: Ganciclovir 5 mg/kg q 12h IV x 14–21days, then 5 mg/kg/d or foscarnet 60 

mg/kg IV q 8 h x 14–21 days, then 90–120 mg/kg/d single dose x 14 days or cidofovir 

5 mg/kg/d weekly x 2 IV or 1 hr x 2 wks, then 5 mg/kg IV every other wk; patient must be 

hydrated with ≥ 1 L saline prior to cidofovir and receive probenecid 2 gm 3 hrs prior to 

cidofovir and 1 gm at 2 and 8 hrs after or fomivirsen intravitreal infections (relapses only)

• Maintenance therapy:

- Preferred: Valganciclovir 900 mg po qd or foscarnet 90–120 mg/kg/d IV until: inactive 

disease, CD4 > 100–150 mm3 x 6 mo and consultation with ophthalmologist

- Implant: Need replacement q 6–8 mo if CD4 < 100–150/mm3

- Alternative: Maintenance ganciclovir, cidofovir

• Immune reconstitution uveitis (IRU): periocular steroids or short course systemic steroids

CMV esophagitis or colitis

• Preferred: Ganciclovir or foscarnet IV x 21–28 days or until symptoms resolve; 

valganciclovir po is appropriate if symptoms are not severe

• Maintenance: Not necessary except if there are relapses

CMV pneumonia

• Indication to treat: Histologic evidence of disease and failure to respond to other pathogens

CMV neurologic disease

• Preferred: Ganciclovir + foscarnet IV (above doses) until improvement 

• Maintenance: Lifetime

Hepatitis B

• Indication for treatment: HBV:(HbeAg pos or HBV DNA >105/mL) + (liver disease by 

histopathology or ALT > 2x ULN)

• HBV + HAART:

- Preferred: TDF/FTC or TDF/3TC

- Alternative: (3TC or FTC) + adefovir or entecavir

- Preferred eAg pos: Peginterferon x 48 weeks

• HBV without HAART: Adofovir, entecavir or peginterferon
50 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Adult OI Table 6. – continued

Management of Opportunistic Infections

(MMWR 2004; 53 RR 15)

Hepatitis C

• Indications to treat: HCV RNA > 50 IU/mL, liver biopsy showing fibrosis or inflammation, 

no contraindications, stable HIV and (?) CD4 > 200/mm3

• Preferred: Peginterferon alfa2a 180ug or peginterferon alfa 2b 1.5 mg/kg, each SC q 9 

weekly + ribavirin 400 mg bid po x 48 weeks

Herpes simplex: Moderate or severe mucocutaneous

• Preferred: Acyclovir 5 mg/kg q 8 h IV, then famciclovir 500 mg bid po or valacyclovir 1 gm 

bid po or acyclovir 400 mg tid po until lesions heal

• Acyclovir resistant: Foscarnet 120–200 mg/kg/d IV in 2–3 doses or cidofovir 5 mg/kg 

weekly until clinical response

Herpes zoster

• Dermatomal: Famciclovir 500 mg tid po or valciclovir 1 gm tid po x 7–10 days

• Extensive cutaneous or visceral: Acyclovir 10 mg/kg q 8 h IV until response

Microsporidiosis

• Preferred: HAART + symptomatic treatment

• Enterocytozoon bieneusi (80% of diarrheal disease due to microsporidia): Fumagillin 60 

mg/d po

• Non-enterocytozoon bieneusi (20% of diarrheal disease): Albendazole 400 mg po bid until 

CD4 > 200/mm3

• Disseminated disease: Itraconazole 400 mg/d, albendazole 400 mg bid (Brachiola or 

Trachipleistophora)

Mycobacterium avium

• Preferred: Clarithromycin 500 mg bid po plus ethambutol 15 mg/kg/d po ± rifabutin 300 

mg/d po until treatment ≥ 12 mo + asymptomatic + CD4 > 100/mm3 ≥ 6 mo

• Alternative: Azithromycin 500–600 mg/d po in place of clarithromycin

• Alternative “3rd drug”: ciprofloxacin 500–750 mg bid po or levofloxacin 500 mg/d po or 

amikacin 10–15 mg/kg/d IV

• Immune reconstitution: Moderately severe — NSAIDs; severe or persistent — prednisone 

20–40 mg/d x 4–8 weeks

Mycobacterium tuberculosis (see Adult OI Tables on tuberculosis)
U.S. Department of Health and Human Services 51

Adult OI Table 6. – continued

Management of Opportunistic Infections

(MMWR 2004; 53 RR 15)

Pneumocystis jiroveci (also known as Pneumocystis carinii)

• Preferred: TMP–SMX 15–20 mg TMP/kg/d IV in 3–4 daily doses or 2 DS tid po x 21 days

• Alternative (IV therapy): Pentamidine 3–4 mg/kg IV infused over 1 hr or dapsone 100 

mg/d po + TMP 15 mg/kg/d (3 daily doses) or primaquine 15–30 mg (base)/d po + 

clindamycin 600–900 mg q 6–8 h IV or 300–450 mg q 6–8 po or atovaquone 750 mg bid 

po (with food)

• PaO2 < 70 mm/Hg room air or A–a gradient: Day 1–5 40 mg bid; Day 6–10 40 mg/d; 

Day 11–21 20 mg/d

• Maintenance

- Preferred: TMP–SMX 1 DS/d or 1 DS bid po

- Alternative: Dapsone 100 mg/d po or dapsone 50 mg/d + pyrimethamine 50 mg/wk 

po + leucovorin 25 mg/wk po or aerosolized pentamidine 300 mg q mo or atovaquone 

1500 mg/d po; All until CD4 > 200/mm3 x ≥ 3 mo

Toxoplasmosis

• Preferred: Pyrimethamine 200 mg/d po x 1 then 50 mg/d (<60 kg) or 75 mg/d (> 60 

kg) plus sulfadiazine 1000 mg q 6 h po (< 60 kg) or 1500 mg q 6 h po (> 60 kg) plus 

leucovorin 10–20 mg/d po (up to 50 mg/d) x ≥ 6 weeks

• Alternative: Pyrimethamine and leucovorin (above doses) plus

 1) Clindamycin 600 mg q6 h IV or po or

 2) Atovaquone 1500 mg bid po or

 3) Azithromycin 900–1200 mg/d po

 4) TMP–SMX 5 mg/kg TMP bid IV or atovaquone 1.5 gm bid po (with meals)

• Maintenance

- Preferred: Sulfadiazine 500–1000 mg qid po + leucovorin 10–25 mg/d

- Alternative:

 1) Clindamycin 300–400 mg q 6–8 h plus pyrimethamine 25–50 mg/d + 

leucovorin 10–25 mg/d

- 2) Atovaquone 750 mg q 6–12 h ± pyrimethamine 25 mg/d + leucovorin 10 mg/d 

Continue until CD4 ≥ 100/mm3, continue maintenance until CD4 >200/mm3 x ≥ 6 months
52 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Occupational HIV Postexposure Prophylaxis (PEP) 

Considerations in Occupational Exposure to HIV

PEP Guidelines

 Updated US Public Health Service Guidelines for the Management 

of Occupational Exposures to HIV and Recommendations for 

Postexposure Prophylaxis. MMWR Recommendations and Reports. September 30, 2005; 54 (RR-9):1. Available at http://www.cdc.gov/mmwr/

Risk of HIV transmission

 The risk of transmission continues to be related to exposure to 

infectious material and the source of that material. Exposure is 

defined as either percutaneous injury with a contaminated sharp 

object or exposure of mucous membranes or nonintact skin (skin 

that is abraded, chapped or with dermatitis) to infectious material. 

The current understanding of exposure contingencies is summarized 

in Occupational Postexposure Table 1.

 The risk of HIV transmission (without prophylaxis) is 0.3% (3/1,000) 

from percutaneous injury and 0.09% (9/10,000) from mucocutaneous 

exposure. The following are associated with increased risk of 

transmission: device (needle) with visible blood, needle placed in 

artery or vein, deep injury, large volume, high viral load.

Efficacy of PEP

 The efficacy of AZT monotherapy prophylaxis is estimated to be 

80% in retrospective case control series. To date there have been 

only six recorded prophylaxis failures associated with occupational 

exposures in the US.
U.S. Department of Health and Human Services 53

Occupational Postexposure Table 1.

 Exposure Contingencies

Exposure Element Explanation

Material

Blood or bloody body fluid Established risk of transmission with 

occupational exposure

CSF; pleural pericardial, peritoneal, amniotic 

and vaginal fluids; semen

Theoretical risk of transmission

Urine, stool, nasal secretions, sputum, tears, 

vomitus (if not bloody)

Not potentially infectious

Type of Exposure

Percutaneous

Not severe

More severe

Solid needle or superficial injury, etc.

Large bore hollow needle, deep injury, or 

visible blood on needle/device

Mucocutaneous

Small volume

Large volume

Few drops

Major splash

Source of Infectiousness

HIV positive

Low risk

High risk

HIV positive and asymptomatic, 

viral load < 1500 c/mL

HIV positive and symptomatic, AIDS, acute 

retroviral syndrome, or known high viral load 

Source unknown For example, deceased source person with 

no samples available for HIV testing
54 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Occupational Postexposure Table 2. 

Indications for HIV PEP

Source

Type of Exposure

Percutaneous Muscocutaneous

Not Severe* More Severe* Small Volume* Large Volume*

HIV Positive

Low Risk*† 2 drugs ≥ 3 drugs 2 drugs 2 drugs

High Risk*† 3 drugs ≥ 3 drugs ≥ 3 drugs ≥ 3 drugs

Source Unknown

— None or 

2 drugs‡

None or 

2 drugs‡

None or 

2 drugs‡

None or 

2 drugs‡

* See Occupational Postexposure Table 1 for explanation

† HIV resistance is a concern get expert consultation

‡ PEP is optional based on discussion of risk:benefit
U.S. Department of Health and Human Services 55

Management of Health Care Workers (HCWs) 

With Potential HIV Exposure

The importance of rapid action in the event of a potential exposure 

cannot be over-emphasized since PEP, if warranted, needs to be 

initiated within hours.

Assessment

Documentation of the nature and degree of the exposure and the 

HIV status of the source patient need to be identified. Rapid testing 

of previously untested source patients is valuable in determining the 

need for PEP. The need for PEP and potential number of drugs may 

be determined by using Table 2.

Initiation of HIV PEP

 Initiate PEP as soon as possible, preferably within hours after 

exposure, and continue for 4 weeks. From a practical point of 

view, PEP should be initiated if the source person is HIV-infected 

or thought to be infected, especially if the results of HIV serology 

likely to be delayed. PEP may be discontinued if the source is 

determined to be uninfected. The current recommended PEP 

regimens are listed in Table 3.

 The following drugs are not recommended because of the 

potential for adverse events: abacavir, delavirdine, zalcitabine, 

didanosine with stavudine, and nevirapine. During pregnancy 

efavirenz should be avoided because of the risk of teratogenic 

effects and the combination didanosine with stavudine because 

of toxicity concerns. Additionally, indinavir should be avoided 

because of side effects in the newborn. 

 Health care workers taking PEP report adverse reactions at the 

rate of 17–47%. The most frequently reported reactions were 

nausea — 27%, malaise and fatigue — 23%. Of 503 HCW who 

prematurely (<28 days) stopped PEP, 24% did so because of 

adverse reactions. Regardless, the HCW should be advised on the 

need to complete the 4–week course of PEP.
56 A Pocket Guide to Adult HIV/AIDS Treatment – February, 2006

Management of Health Care Workers (HCWs) 

With Potential HIV Exposure – continued

Expert Consultation

 Consultation with an expert in HIV exposures and PEP is 

encouraged especially in the following instances:

• Initiation of PEP is delayed to > 24–36 hrs post-exposure

• The status of the source patient is unknown

• The HCW is currently pregnant or is breastfeeding

• The source patient is known to have a resistant HIV strain

• There are toxicity problems in the initiated regimen

Monitoring

• Re-evaluate HCW at 72 hours, especially if additional 

information becomes available about the status of the source

• HIV serology testing should be conducted at baseline, and then 

at 6 weeks, 12 weeks, and 6 months after exposure; if the 

HCW experiences hepatitis C seroconversion after exposure, 

HIV serology should be conducted 12 months after exposure

• Tests for HIV (P24 Ag or HIV PCR) in HCW are not routinely 

recommended due to high rates of false positives; these tests 

should be done if there are symptoms compatible with the 

acute retroviral syndrome

• Toxicity monitoring

Laboratory: CBC, liver and renal function tests at baseline and 

at 2 weeks; HCWs given indinavir should also have urinanalysis 

monitoring for crystalluria and hematuria

 Self Report: HCWs should be advised to report rash, fever, back 

or abdominal pain, dysuria, blood in urine, and symptoms of 

hyperglycemia; they should also be counseled on the possibility 

of drug interactions and advised to report these should they occur

Prevention Warnings

 HCW with exposure to HIV should be counseled on measures to 

prevent secondary transmission including: avoidance of blood or 

tissue donations; pregnancy and breastfeeding, especially in the 

first 6–12 weeks; and the use of condoms for sexual transmission.

Seroconversions

 Report any Seroconversion to your local Health Department.
U.S. Department of Health and Human Services 57

Occupational Postexposure Table 3. 

Recommended Regimens

2 Drug Regimen 3 Drug Regimen

Lamivudine or emtricitabine plus

 zidovudine, stavudine or 

tenofovir

Two nucleosides plus

Preferred: lopinavir/ritonavir

Alternates: atazanavir, fosamprenavir, ritonavir boosted 

indinavir, ritonavir boosted saquinavir or nelfinavir*

* Consider EFV if PI resistance in source and HCW has no pregnancy risk

Resources for Consultation

 The following resources are available for consultation regarding HIV PEP:

• PEPline: http://www.ucsf.edu/hivcntr

Telephone: 1-888-448-4911

• HIV Pregnancy registry: http://www.apregistry.com/index.htm

Telephone: 1-800-258-4263, email —registry@nc.crl.com

• FDA (for reporting unusual or severe toxicity to antiretroviral 

agents) at http://www.fda.gov/medwatch

Telephone: 1-800-332-1088

• Report HIV infections in HCP and failures of PEP to local 

Health Department. 

• HIV/AIDS Treatment Information Service: http://aidsinfo.nih.gov
A Pocket Guide to Adult HIV/AIDS Treatment

provides treatment information in table form

for easy reference in clinical settings:

AIDSInfo: http://www.aidsinfo.nih.gov

National HIV/AIDS Clinical Consultation Center War

1-800-933-3413

(toll free in the U.S.)

Drug Information ...................... Pages 2-16

Adult ART Tables .................... Pages 17-29

Pregnancy Tables ................... Pages 30-34

Prevention for Providers ....... Pages 35-37

Adult OI Tables ....................... Pages 38-51

Occupational PEP .................. Pages 52-58

Recommendations for HIV care and treatme

are complex and change rapidly. In addition 

to the Pocket Guide and A Guide to Primary 

Care of People with HIV/AIDS, which the Pock

Guide supports, consult the following resour

provided by the U.S. Department of Health 

and Human Services for frequently updated 

HIV treatment information: