To order copies of the guide, contact:

HRSA Information Center

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

2710 Prosperity Ave, Suite 200

Fairfax, VA 22031

The Pocket Guide can also be viewed or ordered on the 

HRSA HIV/AIDS Bureau website: 

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

August 2004 Edition

A Pocket Guide to 

Adult HIV/AIDS Treatment:

Companion to 

A Guide to Primary Care of 

People with HIV/AIDS People with HIV/AIDS

A Guide to Primary Care of 

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 – August, 2004

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 August 2004

Acknowledgements

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

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 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 ............................................................................ 10

Drug Table 4. Combination Antiretroviral Therapy, Dose Adjustments ...................11

Drug Table 5. Drug Interactions: Contraindicated Combinations ........................... 12

Drug Table 6. Drug Interactions: Nucleosides ........................................................ 13

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

Requiring Dose Modifi cations ................................................................ 14

Antiretroviral Therapy

Adult ART Table 1. When to Start Therapy ............................................................ 16

Adult ART Table 2. Suggested Minimum Target Trough Levels ............................... 16

Adult ART Table 3. Starting Regimens for Antiretroviral Naïve Patients ................. 17

Adult ART Table 4. Advantages and Disadvantages of Antiretroviral Regimens ...... 18

Adult ART Table 5. Antiretroviral Regimens or Components 

That Are Not Generally Recommended ................................................. 19

Laboratory Monitoring .......................................................................................... 21

Adult ART Table 6. Resistance Mutations ............................................................... 22

Therapeutic Failure ............................................................................................... 24

Methods to Achieve Readiness to Start HAART & Maintain Adherence .................. 27

Adult ART Table 7. National Cholesterol Education Program: Indications 

for Dietary or Drug Therapy for Hyperlipidemia .................................... 29

Adult ART Table 8. Drug Therapy for Hyperlipidemia ........................................... 30
iv A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Pregnancy and HIV

Pregnancy Table 1. Antiretroviral Drugs in Pregnant Women ................................ 31

Pregnancy Table 2. Pregnancy Issues .................................................................... 32

Pregnancy Table 3a. Antiretroviral Agents: Pharmacokinetic and 

Toxicity Data ......................................................................................... 33

Pregnancy Table 3b: Antiretroviral Agents: Recommendations for Use ................. 34

Pregnancy Table 4. Clinical Scenarios and Management of Untreated 

Pregnant Patients Including C-Section ................................................... 35

Pregnancy Table 5. Clinical Scenarios and Management of Treated 

Pregnant Patients Including C-Section ................................................... 36

Pregnancy Table 6. Delivery Procedures and Therapy ........................................... 36

Prevention of HIV for Providers in Three Steps

Prevention of HIV for Providers in Three Steps ..................................................... 37

Opportunistic Infections

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

Opportunistic Infections ........................................................................ 40

Tuberculosis and HIV ............................................................................................ 44

Adult OI Table 2. Recommended Drug Regimens for Treatment of 

Latent TB in HIV Co-infected Adults ....................................................... 45

Adult OI Table 3. Monitoring of Patients on Latent TB Prophylaxis ........................ 46

Treatment of Tuberculosis Disease ........................................................................ 47

Adult OI Table 4. Treatment of Drug-Susceptible TB .............................................. 47

Adult OI Table 5. Doses of Antituberculosis Drugs – First-line Drugs ..................... 48

Adult OI Table 6: Special Considerations for TB Treatment 

with HIV Co-infection .................................................................48
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: August, 

2004). Available at http://www.aidsinfo.nih.gov/guidelines/

• 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic 

Infections in Persons Infected with Human Immunodefi ciency Virus. 

November 28, 2001. 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, 2004. 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/.

• Sexually Transmitted Diseases Treatment Guidelines 2002. May 10, 

2002. MMWR Recommendations and Reports, Vol. 51 / No. RR-6. 

Available at http://www.cdc.gov/std/treatment/rr5106.pdf.

• 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 

Immunodefi ciency 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 HBV, HCV, and HIV and recommendations 

for postexposure prophylaxis. MMWR 2001;60RR-11. Available at 

http://www.cdc.gov.
vi A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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 confi rm 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 ( amprenavir (Agenerase Agenerase) LPV/r: lopinavir/ritonavir (Kaletra)

ATV: atazanavir (Reyataz) NFV: nelfi navir (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) 3TC: lamivudine (Epivir)

FTV: Fortovase (saquinavir, soft gel cap) T-20: enfuvirtide (Fuzeon)

FPV: fosamprenavir (Lexiva) TDF: tenofovir (Viread)

HU: hydroxyurea TMP-SMX: trimethoprim sulfamethoxazole

IDV: indinavir (Crixivan) TZV: Trizivir (ABC+AZT+3TC)

INH: isoniazid VZIG: varicella zoster immune globulin

INV: Invirase (saquinavir, hard gel cap) 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 – August, 2004 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; Videx EC; ddI)†

25, 50, 100, 150, 200 mg buffered tabs 125, 200, 250, and 400 mg EC caps

>60 kg <60 kg 1⁄2 hr before 

or 2 hr after mealSeparate dosing of IDV, RTV, DLV, ATV

>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 §

Tabs 400 mg qd or 200 mg bid 250 mg qd or 125 mg bidEC Caps 400 mg qd 250 mg qdIf tabs must take 2 for proper buffering

Emtricitabine (Emtriva, FTC) 200 mg cap 200 mg qd No effect 200 mg q72 h 200 mg q96 h Usual Minimal§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§

Epzicom 3TC 300 mg + ABC 600 mg 1 qd 1 qd No effect Fixed formulation not recommended in renal failure Usual ABC hypersensitivity

Footnotes for Drug Table 1 can be found on page 7
U.S. Department of Health and Human Services 3

Stavudine (Zerit; d4T) †

15, 20, 30, 40 mg cap; 75, 100 mg XR cap (not available)1 mg/mL po soln.

Wt >60 kg: 40 mg bid or 100XR qd Wt <60 kg: 30 mg bid or 75XR qd No effect

>60 kg-20 mg q 12 h<60 kg15mg q 12 h

>60 kg-20 mg q 24 h<60 kg-20 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 300 mg qd Take with meal 300 mg 48 hr 300 mg 2 days/wk 300 mg q 7 days¶ Usual Minimal. Renal toxicity (rare)§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)§

Truvada TDF 300 mg + FTC 200 mg 1 qd No effect Fixed formulation not recommended in renal failure Usual Minimal. Renal toxicityZalcitabine (Hivid; ddC)

0.375, 0.75 mg tab 0.75 mg tid No effect Standard 0.75 mg bid .75 mg qd Usual

Peripheral eripheral Pneuropathy, stomatitis§

Zidovudine (Retrovir, AZT)

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

300 mg bid 200 mg tid No effect 300 mg bid 300 mg qd 100 mg tid 200 mg bid

Anemia, neutropenia,headache, asthenia, GI intolerance§
4 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004 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 Protease Inhibitors (PIs) Amprenavir (APV, Agenerase) 50, 150 mg caps 15 mg/mL po soln ** >50 kg: 1200 mg bid (caps) or 1400 mg bid (po soln.) or APV 600 mg/RTV 100 mg bid or 1200 mg/200 mg qd# <50 kg: 20mg/kg bid (caps) max 2400 mg daily total <50 kg: 1.5mL/kg bid (soln) max 2800 mg daily total Avoid high fat meal Standard No data CPS* 5-8: 450 mg bid CPS* 9-12: 300 mg bid GI intolerance, rash, oral paresthesias, hepatitis ‡‡ Atazanavir 

(Reyataz, ATV)

100, 150, and 200 mg capsules

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

Take with food. Avoid concurrent buffered ddl, antacids.

Standard

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

Benign increase in indirect bilirubin, GI intolerance, 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, 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, benign increase in indirect bilirubin ‡‡

Lopinavir/ Ritonavir (LPV/r) (Kaletra)

LPV 133.3 mg + RTV 33.3 mg (cap); LPV 80 mg + RTV 20 mg/mL po soln

400 mg LPV + 100 mg RTV (3 caps) bid Soln: 5 mL bid

Take with food Standard §§ 

GI Intolerance (esp. diarrhea), asthenia ‡‡

Nelfi navir (NFV, Viracept)

250, 625 mg tabs 50 mg/g powder

1250 mg bid or 750 mg tid

Take with high fat meal

Standard §§ Diarrhea ‡‡

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, hepatitis, taste perversion ‡‡

Saquinavir (SQV) Fortovase (FTV) Invirase (INV)

200 mg caps

FTV – 1200 mg tid or with RTVSQV 400 + RTV 400 bid or SQV 1000 mg bid + RTV 100 bid ††SQV 1600 mg qd + RTV 100 mg qd †† 

(FTV): Take with large meal unless combined with RTV

Standard §§

GI intolerance, (Invirase preferred) hepatitis ‡‡
6 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004 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 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Delavirdine (DLV, Rescriptor) 100, 200 mg tabs 400 mg tid Separate buffered ddI or antacid ≥ 1 hr No effect Standard §§ Rash, hepatitis Efavirenz ††† (EFV, Sustiva) (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 fi rst 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, bacterial pneumonia
U.S. Department of Health and Human Services 7

†

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

†† Invirase generally preferred when taken with ritonavir. Invirase not recommended as sole PI.

‡ Drug change or dose change could be considered on a case-by-case basis noting the risk of resistance with underdosing. ** APV caps and solution NOT interchangeable on mg per mg basis. 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 pg 8). Most common with d4T, ddl, and AZT.

# See Drug Table 4, pg 11 for dosing recommendations when using dual PI, PI plus NRTI, or dual PI plus NNRTI.

¶ Give post dialysis * Child Pugh Score

¶¶ Registry for hypersensitivity 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 fi rst 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 hepatitis (see pg 8).
8 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004 Drug Table 2. Antiretroviral Agents, Class Adverse Reactions Reaction Lactic acidosis Hepatotoxicity Hyperglycemia Fat redistribution Hyperlipidemia Rash Defi nition Lactic acid >2 mmol/mL usually >5 mmol/mL • Gr III = AST/ALT 5-10 X ULN • GR IV = ADT/ALT > 10 x ULN Fasting glucose >126 mg/dL Fat accumulations, Lipoatrophy See Adult ART Table 5 Frequency 1.3% NRTI recipients with median onset at 4 mo. • NRTIs: d4T, ddI, AZT (lactic acidosis) • PIs- (15-30%) esp. RTV (dose related) • NVP - 11% in fi rst 6 wks in women with baseline CD4 >250; possible hepatic necrosis and death • NNRTI: NVP-hepatotoxicity (15%); EFV (8%) 3-17% with PIs 4-50% NNRTI: 8-16% Agents NRTIs d4T+ddI>d4T> ddI>AZT; rare with 3TC, ABC, FTC or TDF All antiretrovirals; most common - NVP and RTV 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 - APV, increased risk with sulfa allergy. NRTI - ABC* Risk Factors Prolonged use NRTI (esp d4T) Female, pregnancy, obesity, ribavirin, metformin HCV or HBV infection, ETOH, male sex NVP - high baseline CD4, female Pre-existing glucose intolerance No clear risks defi ned Risk for CVD - HBP, smoking, obesity, genes, prior MI/stroke, diabetes, age NNRTI - 1st 12 wks Female
U.S. Department of Health and Human Services 9

Sx 

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

Asymptomatic or sx of hepatitis.Note: indirect bilirubin with IDV or ATV is inconsequential

Polyuria, polydipsia, polyphagia, weight loss 

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

Cardiovascular disease with stroke or MI/angina.Triglycerides >2000 mg/dL - pancreatitis

Common - MP rashSevere -Stevens-Johnson synd, TEN,# DRESS *

Lab

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

LFTs; liver biopsy is usually not helpful. 

Fasting glucose >126 mg/dL 

CT scan, MRI Waist: Hip, Bioelectric Impedence. DEXA, Ultrasound

triglyceridescholesterol, & LDL 

cholesterol

Eosinophilia - variable

Treatment 

Lactate 2-5 mmol/mL + Sx -D/C NRTI if sx severeLactate level is 5-10 mmol/mL - D/C NRTIs.Lactate >10 mmol/mL (medical emergency) - D/C NRTIs + supportive care: ventilator, dialysis, IV HCO3IV thiamine or ribofl avin (?)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 fi rst 6 wks): D/C drug immediately and do not rechallengeAsymptomatic elevations of LFT (<10 X ULN): repeat LFTs q 1-2 wksSymptomatic or elevations of LFT (>10 X ULN) or hyperlactatemia or hypersensitivity (ABC or NVP): change regimen.

Use standard diabetes treatment with diet and exercise.Preferred hypoglycemics are: metformin or thiazolidinediones.D/C PI only if uncontrolled hyperglycemia 

No established RxExercise?Change PI to ATV or NNRTILipoatrophy- d/c d4T

NECP guidelines (pg 29):• General †• LDL cholesterol 

Statins

• Triglycerides Fibrate

Most rashes do not require drug discontinuation.Withdraw NNRTI if severe; may tolerate other NNRTI EFV).

Monitor During Therapy

None LFTs at baseline and q 

3 mo NVP–LFTs at wks 0,2,4,8,12 then q 3 mo

Fasting glucose baseline, at 3-6 mo, then yearly. 

Appearance Fasting lipid profi le 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 fi rst 6 weeks of therapy.†Lifestyle changes: d/c smoking, diet, weight reduction, exercise, tx HBP and diabetes.# TEN: Toxic epidermal necrolysis
10 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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, & with 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 w/ steatosis

Enfuvirtide None

Indinavir None

Lamivudine Lactic acidosis with steatosis. Patients with HIV infection should receive only 

dosage and formulations appropriate for treatment of HIV.

Lopinavir None

Nelfi navir None

Nevirapine 

Hepatotoxicity including fulminant and cholestatic hepatitis & hepatic necrosis: 

monitor intensively in fi rst 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

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
U.S. Department of Health and Human Services 11

Drug Table 4. 

Combination Antiretroviral Therapy, Dose Adjustments*

RTV SQV NFV APV 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

IDV 600 

bid

LPV/r-SD

NR

NVP-SD

IDV 1000 

q8h

EFV-SD

IDV- 1000 

q8h

RTV -

SQV/r 

1000/100 

or 

400/400 

bid

NFV 

500-

750+ 

RTV

APV/r 

600/100 

bid or 

1200/200 

qd

co-form.

ATV/r 

300/100 

qd

NVP-SD

RTV-SD

EFV-SD

RTV-SD

SQV - -

NFVSD + 

SQV 

1200 

bid

ND

SQV 

1000 bid 

+ LPV/rSD

SQV 1600 

+

ATV 300+

RTV 100 

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

APV - - - -

APV 

600-750 

bid + 

LPV/r 

533/133 

bid

NR ND

EFV-SD

APV-600 

bid + RTV 

100 bid

FPV

FPV/r 

1400/ 

200 

qd or 

700/100 

bid; see 

EFV

ND - - 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

* Doses are in mg; ND = Inadequate data; NR = Not recommended; SD = Standard dose
12 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Drug Table 5. 

Drug Interactions: Contraindicated Combinations

Class Contraindicated 

Agent ART Agents Alternatives

Ca++ channel blocker Bepridil RTV, APV, ATV -

Antiarrythmics 

Flecainide, 

Propafenone RTV, LPV/r, FPV -

Amiodarone, quinidine RTV

Lipid lowering 

Simvastatin, Lovastatin All PIs, DLV 

Pravastatin or 

Fluvastatin, possibly 

Atorvastatin, 

Rosuvastatin

Atorvastatin NFV, LPV Pravastatin or 

Fluvastatin

Antimycobacterials

Rifampin

All PIs except SQV + 

RTV; 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, or 

Oxazepam†† Alprazolam DLV

Ergot alkaloids Ergotamine All PIs, DLV, EFV -

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

antidepressants

* 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.

†† Reviewer opinion
U.S. Department of Health and Human Services 13

Drug Table 6. 

Drug Interactions: Nucleosides

Drug AZT d4T ddI TDF

Methadone AZT AUC 40%;

no dose change

d4T 27%; 

no dose change

ddI 61% 

consider 

ddI dose or use 

ddI EC

No data

ddI - Magnifi es toxicity. 

Use with caution. - ddI 44% 

consider ddI dose 

reduction.

Ribavirin 

Inhibits AZT 

activation. Avoid 

if possible

No data Magnifi es ddI 

toxicity; avoid. No data

ATV - - 

Buffered ddl 

- take ATV 2 hr 

before or 1 hr 

after ddl. ddl EC 

- separate dosing 

due to food 

restrictions.

Avoid concomitant 

use unless ATV 

combined with 

RTV.

IDV - - Buffered ddI 

– take 1 hr apart -

Cidofovir 

Ganciclovir 

Valgancyclovir - - -

Combinations 

may decrease 

CrCl
14 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Drug Table 7. 

Drug Interactions: Combinations with 

PIs or NNRTIs Requiring Dose Modifi cations

Class Agent ART

Antifungal 

Ketoconazole 

IDV– IDV 600 mg tid

RTV, LPV/r–Ketoconazole ¡Ü200 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, APV, FPV, 

LPV/r; IDV is OK

Itraconazole IDV dose + 600 mg tid (unless boosted); Itraconazole 

dose ≤ 200 mg bid

Oral 

contraceptives -

Additional method of contraception recommended with: 

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

No data – SQV. DLV ethinyl estradiol by 20%

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 decrease methadone levels and require monitoring 

for withdrawal. Methadone decreases buffered ddI levels 

- consider ddI EC (no interaction).

Antibiotics Clarithromycin 

RTV, LPV/r, DLV – Decrease clarithromycin dose in renal 

failure.

EFV, ATV – Consider alternative to Clarithromycin (e.g. 

Azithromycin)

Erectile 

dysfunction

Sildenafi l PIs + DLV: ≤ 25 mg q48 h

Vardenafi l PIs + DLV: ≤ 2.5 mg/d

Tadalafi l PIs + DLV: ≤ 10 mg q48 h
U.S. Department of Health and Human Services 15

Drug Table 7. – continued

Drug Interactions: Combinations with 

PIs or NNRTIs Requiring Dose Modifi cations

Class Agent ART

Antimycobacterials

Rifabutin 

APV 1200 mg bid + RBT 150 mg/d or 300 mg 3x/wk

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

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

RTV (any dose) + PI RBT 150 mg qod or 3x/wk

Rifampin 

All PIs & NNRTIs contraindicated except RTV+SQV, or EFV 

using standard doses of rifampin; with EFV consider EFV 

daily dose of 800 mg qd.

Lipid Lowering 

Lovastatin, 

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

Atorvastatin PI and DLV: use with caution and monitor.

Pravastatin No dose change- RTV, SQV, LPV/r. No data-IDV, NFV, APV, 

and 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

Atazanavir

Antacids + buffered meds – give ATV 1 hr before 

or 2 hrs after

H2 receptor antagonist – separate dosing by 12 hrs

Ca channel blockers – dose titration + EKG monitoring

Diltiazem – Reduce diltiazem dose 50% + monitor EKG
16 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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 

especially if VL is 

>20,000 c/mL, but 

controversial †

Asymptomatic CD4+ > 350/mm3 > 55,000 c/mL 

Consider Therapy 

or Observe † Data 

inconclusive for either 

alternative

Asymptomatic CD4+ > 350/mm3 < 55,000 c/mL Defer therapy and 

observe

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

† Patient readiness, probability of adherence, and prognosis based on CD4 count and HIV load 

need to be considered

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
U.S. Department of Health and Human Services 17

Adult ART Table 3. 

Starting Regimens for Antiretroviral Naïve Patients

NRTI-Based Regimens # of pills per day

Preferred Regimens 

efavirenz + lamivudine + (zidovudine or 

tenofovir DF or stavudine) – except for pregnant 

women or women with pregnancy potential

3–5

Alternative Regimens 

• efavirenz + (lamivudine or emtricitabine) + 

didanosine or abacavir - except for pregnant 

women or women with pregnancy potential

3–5

• efavirenz + emtricitabine + (zidovudine or 

tenofovir or stavudine*) - except for pregnant 

women or women with pregnancy potential

3

• nevirapine + (lamivudine or emtracitabine) 

+(zidovudine or stavudine* or didanosine) 

(Note: High incidence of symptomatic hepatitis 

with NVP in women with baseline CD4>250 

and men with over 400)

4–5

PI-Based Regimens # of pills per day

Preferred Regimens lopinavir/ritonavir + lamivudine + (zidovudine 

or stavudine) 8–10

Alternative Regimens 

• atazanavir + (lamivudine or emtricitabine) + 

(zidovudine or stavudine* or abacavir) 4-5

• fosamprenavir + (lamivudine or emtricitabine) 

+ (zidovudine or stavudine* or abacavir) 6-8

• fosamprenavir/ritonavir + (lamivudine or 

emtricitabine) + (zidovudine or stavudine* or 

abacavir)

6-8

• indinavir + ritonavir† + (lamivudine or 

emtricitabine) + (zidovudine or stavudine* or 

abacavir)

8-11

• nelfi navir + (lamivudine or emtricitabine) + 

(zidovudine or stavudine* or abacavir) 6–7

• saquinavir (sgc or hcg) + ritonavir + 

(lamivudine or emtricitabine) + (zidovudine or 

stavudine* or abacavir)

14-16

• lopinavir/ritonavir + emtricitabine + 

(zidovudine or stavudine* or abacavir) 8-9

Triple NRTI Regimen – 

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

Alternative Regimens • abacavir + lamivudine + (zidovudine or 

stavudine*) 2-6

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

NRTIs.

† Low-dose (100-400 mg) ritonavir
18 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Adult ART Table 4. 

Advantages and Disadvantages of Antiretroviral Regimens

Advantages Disadvantages

NNRTIs Class— less lipodystrophy

Save PI option

Low genetic barrier to resistance

Class resistance / Drug interactions

EFV Potent

Low pill burden qd, no food effect

CNS toxicity

Teratogenic

NVP Extensive experience in pregnancy

ADR- hepatotoxicity + rash

Contraindicated in women with baseline CD4 

count >250

PI Class— extensive experience

Save NNRTI option

ADR— lipodystrophy

Multiple drug interactions

ATV

Once daily dosing

Low pill burden

No hyperlipidemia

ADR-Jaundice + PR prolongation

Drug interaction with TDF

LPV/r Potency

Coformulated with RTV

ADR-GT intolerancy

Food requirement

Minimal experience in pregnancy

FPV/r

Low pill burden

No food effect

Once daily dosing

ADR- skin rash

IDV/r No food requirement ADR-Nephrolithisis

Requirement for po fl uid

NFV Substantial experience in pregnancy

High

ADR- diarrhea

High rate virologic failure

Food requirement

SQV/r No food effect ADR- GI intolerance

High pill burden

NRTIs

AZT/ 3TC/ 

ABC

Coformulated

No food effect

Preserves PI and NNRTI options

Higher rate of virologic failure

ADR- ABC hypersensitivity

NRTI pairs

AZT/ 3TC*

Extensive experience

Coformulated

No food effect

ADR-GI intolerance + narrow suppression 

(AZT)

d4T/ 3TC* No food effect

Once daily ADR of d4T **

TDF/ 3TC* Well tolerated

Once daily TDF + FTC coformulated Food requirement

ddI/ 3TC* Once daily ADR- ddI**

Food effect

ABC/ 3TC*

Once daily

No food effect

Coformulated

ADR- ABC hypersensitivity

* 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
U.S. Department of Health and Human Services 19

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

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 benefi ts 

outweigh the risks*

ATV + IDV Potential for additive hyperbilirubinemia No exception

FTC + 3TC No potential benefi t No exception

Efavirenz in pregnancy Teratogenic in nonhuman primate 

When no other 

antiretroviral options 

are available and 

potential benefi ts 

outweigh the risks*
20 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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; and

• patients treated with 

metronidazole or 

disulfi ram

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 benefi t 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

APV as single PI Pill burden of 16 caps/day. *

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 *

* Reasonable to use in unusual circumstances.
U.S. Department of Health and Human Services 21

Laboratory Monitoring

• Baseline tests: CBC, chemistry profi le including liver and renal 

function tests. Toxoplasma gondii IgG, VDRL (or RPR), anti-HCV, 

anti-HBc, PPD (If no prior positive - see TB tables), and PAP smear 

for female patients.

• Confi rm 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 signifi cant 

(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

- Suboptimal suppression

- Acute HIV infection 

Consider

- Chronic HIV infection, before therapy

Not Usually Recommended

- After discontinuation of drugs

- Viral load <1,000 c/mL
22 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Adult ART Table 6. 

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, 

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

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

73 S, 90 M

LPV/r

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

IL, 47 VA, 50 V, 53 L, 54 VLAMTS, 71 

VT, 73 S, 82 AFTS, 90 M

ATV 50 L

10 IFV, 20 RMI, 24 I, 32 I, 33 IFV, 36 

ILV, 46 I, 48 V, 54 V, 71 V, 73CSTA, 82 

A, 84 V, 88 S, 90 M

TPV 33 I, 82 AFLT, 84 V, 90 M 10 IV, 20 MLT, 46 I, 54 V

Multi PI 

resistance 46 IL, 82 AFTS, 84 VAC, 90 M

* Adapted from IAS-USA Topics HIV Med 2003; 11:215. See http://www.iasusa.org.

† Major - usually develop fi rst; associated with decreased drug binding; - usually develop first; associated with decreased drug binding; Minor - also contribute - 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. designations for NRTIs and NNRTIs has been suspended.
U.S. Department of Health and Human Services 23

Adult ART Table 6. – 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 44 D, 65 R, 118 I, 184 VI

FTC 65 R, 184 V/I

ddC 65 R, 69 D, 74 V, 184 V

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, 44 D, 67 N, 69 insert, 70 R, 210 W, 215 YF, 219 QE

Multinucleoside TAMS 41 L, 44 D, 67 N, 70 R, 118 I, 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 2003; 11:215. See http://www.iasusa.org.
24 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Therapeutic Failure

Defi nitions

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 fi rst 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
U.S. Department of Health and Human Services 25

Therapeutic Failure – continued

Virologic Failure

• Resistance tests if VL >500-1,000 c/mL (see page 22)

• Options for empiric regimen change:

Initial Regimen New Regimen

NNRTI + 2 NRTIs 2 NRTIs (selected by resistance tests) + PI ± RTV

PI ± RTV + 2 NRTIs 2 NRTIs (selected by resistance tests) + NNRTI

3 NNRTIs 

• 2 NRTIs (selected by resistance tests) + NNRTI or

• 2 NRTIs (selected by resistance tests) + PI ± RTV

• NNRTI + PI ± RTV

• NRTIs (selected by resistance tests) + NNRTI + PI ± RTV

Specifi c Treatment Scenarios

• Limited prior treatment with VL ≤ 5,000 c/mL: consider 

intensifi cation

• Limited prior treatment with single drug resistance: consider single 

drug change or change entire regimen

• Limited prior treatment with and resistance to >1 drug: consider 

change of class (PI NNRTI or NNRTI PI)

• Prior treatment with no resistance: consider non-adherence; if 

treatment interrupted – resume regimen and test resistance at 2-4 

wks.

• Extensive prior treatment: continue failed treatment if there are 

few or no alternative treatment options.
26 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Therapeutic Failure – continued

Novel Strategies

• Therapeutic drug monitoring (optional; not supported by data)

• Retreating with prior drugs (optional; not supported by data)

• Empiric multidrug regimens (mega-HAART with up to 3 PIs and/or 

2 NNRTIs) (not generally recommended)

• Structured treatment interruption (not generally recommended)

• New agents such as enfuvirtide (T20) or drugs available only 

on treatment IND or therapeutic trials (optional; effi cacy 

supported by data)
U.S. Department of Health and Human Services 27

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 refi lls

• 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 refi lls 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
28 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Methods to Achieve Readiness to Start HAART 

& Maintain Adherence – continued

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
U.S. Department of Health and Human Services 29

Adult ART Table 7. 

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 - 499mg/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 fi rst 

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
30 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Adult ART Table 8. 

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 fi brate† 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 specifi c 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), fl uvastatin 20-40 mg/day, or atorvastatin 

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

see Table 6. Drug Interactions: Contraindicated Combinations able 6. Drug Interactions: Contraindicated Combinations.

† Fibrate: Gemfi brozil 600 mg bid ≥ 30 minutes before meal or Fenofi brate tablets (e.g. Tricor) 

160 mg qd Micronized fenofi brate (capsules) 67mg qd to start, max. dose 201 mg qd.
U.S. Department of Health and Human Services 31

Pregnancy and HIV

Pregnancy Table 1. 

Antiretroviral Drugs in Pregnant Women

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 fi rst 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: pharm. antagonism; do not use together. APV oral solution (only) is 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 ( August 30, 2002), Table 2.
32 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Pregnancy Table 2. 

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 defi ciency), 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 -plasma & genital tract (most signifi cant), 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.
U.S. Department of Health and Human Services 33

Pregnancy Table 3a. 

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 C Teratogenic; 4/142 birth defects. Avoid in 1st trimester.

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

dose with labor may cause 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 data

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

* June 23, 2004

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

B=No evidence of risk in humans 

C=Risk cannot be excluded
34 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Pregnancy Table 3b: 

Antiretroviral Agents: Recommendations for Use*

Class Recommendation Drugs

NRTIs

Preferred AZT, ETC

Alternatives ddI, FTC, d4T, ABC

Inadequate data TDF

Not recommended ddC, d4T, ddI

PIs

Recommended NFV, SQV/r

Alternatives IDV, LPV/r, RTV

Inadequate data APV/r, ATV, APV, FPV

NNRTIs

Recommended NVP (caution with baseline CD4 > 250)

Not recommended EFV, DLV

* June 23, 2004

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

B=No evidence of risk in humans

C=Risk cannot be excluded
U.S. Department of Health and Human Services 35

Pregnancy Table 4. 

Clinical Scenarios and Management of 

Untreated Pregnant Patients Including C-Section

Time of 

Presentation Recommended Management

Early In Pregnancy 

(<36 Weeks)

• Standard clinical, immunologic and virologic evaluation, and 

resistance testing (same as other pts).

• If VL >1,000 or CD4 <350, HAART with AZT (076 Protocol); 

but consider delaying ART until after 10-12 wks gestation; some 

authorities delay initiating ART in fi rst trimester due to concerns for 

antiretroviral agents at the time of organogenesis. This risk is not 

established with the possible exception of EFV. See also, Pregnancy 

Table 1 footnotes.

• VL <1,000 and CD4 >350, consider AZT monotherapy (076 

Protocol), AZT +3TC, or HAART after the fi rst trimester for 

prevention of perinatal transmission [J Infect Dis 2001; 183:539]

• Monitor VL and CD4+ to plan for delivery

Late In Pregnancy 

(≥36 Weeks)

• Standard clinical, immunologic and virologic evaluation, and 

resistance testing

• If VL >1,000 or CD4 <350, HAART with AZT (076 Protocol); 

see cautions, Pregnancy Table 1 footnotes.

• VL <1,000 and CD4 >350, consider AZT monotherapy (076 

Protocol), AZT +3TC, or HAART for prevention of perinatal 

transmission; [J Infect Dis 2001; 183:539]

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

risk of transmission to infant, but counsel about risks and benefi ts of 

all choices.

Labor 

• Initiate therapy (See Pregnancy Table 1C, above for Untreated 

Women Presenting In Labor)

• Postpartum immunologic and virologic evaluation of mother for ART.

• Infant should undergo diagnostic testing for HIV to determine need 

for ongoing ART.

Postpartum 

• Initiate the 6 wk neonatal AZT protocol preferably within 6-12 hours 

of delivery.

• Infant should undergo diagnostic testing to determine need for ART.

• The mother should undergo evaluation to determine indications for 

ongoing ART.
36 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Pregnancy Table 5. 

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 1. 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 benefi ts of 

all choices.

C-Section Planned But 

Presents in Labor or With 

Ruptured membranes

• Initiate ACTG 076 Protocol, Intrapartum in Table 1, above

• 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 6. 

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 Table 1, Above.

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 Table 1.A., above.

If UNTREATED mother use treatment from Table 1.C., above 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 37

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

• All women

• All women ≤ 25 years 

and sexually active

• Syphilis serology - RPR or VDRL*

• Trichomonas wet mount or culture

• Cervical specimen for C. trachomatis

Consider

• All men and women not 

included above

• Anal receptive sex

• Oral receptive sex

• Possible pregnancy

• Screening for GC and C. trachomatis by 

urethral (men) or cervical (women) specimen 

or fi rst catch urine for NAAT*

• Anal swab for GC culture and, if available, 

for C. trachomatis

• Pharyngeal culture for GC.

• 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.
38 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

Step 2: Behavioral interventions

• Prevention messages should be provided with each visit

• Communicate factors that infl uence 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 benefi t. With structured 

treatment interruption, warn patient that viral load increases as does 

risk of transmission.
U.S. Department of Health and Human Services 39

Step 3: Partner counseling and notifi cation

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

needlesharing partners.

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

notifi ed.

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

have not been notifi ed.

• Referrals: All contacts should be referred to the Health Department; 

arrange for notifi cation and testing without identifying source. 

Patients who elect not to notify partners should be referred to the 

health department to conduct these activities.
40 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004 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 defi ning 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 Footnotes for Adult OI Table ! are on page 43
U.S. Department of Health and Human Services 41 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 25mg /wk orDapsone 200 mg/wk + pyrimethamine 75 mg/wk + Leucovorin 25/wk orAtovaquone 1500 mg/d ± pyrimethamine 25 mg/d + Leucovorin 10 mg/d

Immune reconstitution recommendations:Discontinue if CD4 >200 cells/mm3for ≥ 3 mos

Restart 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/

Immune reconstitution recommendations:Discontinue if HAART 6-12 mos, CD4 >200 cells/mm3, and asymptomatic.Restart 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
42 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004 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 effi cacy 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 q.d. 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 43

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 NoneInfl uenza 10 All patients Infl uenza vaccine

Rimantidine 100 mg bidAmantadine 100 mg bidOseltamivir 75 mg qd

Hepatitis A 10 Susceptible- (anti-HAV neg) and anti-HCV 

positive

Hepatitis A vaccine series None

* Indication is separately defi ned for:

10 = Primary: No prior infection with this pathogen 20 = 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.
44 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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 45

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 w/ 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 table next page for RBT & PI/NNRTI dose adjustments.† May not be used with patients taking PI/NNRTI with the exception of RTV/SQV, RTV, or EFV.
46 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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.

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 

fi rst 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 Adult ART Table 6, pg 22
U.S. Department of Health and Human Services 47

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

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 week (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.
48 A Pocket Guide to Adult HIV/AIDS Treatment – August, 2004

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

1,200 mg

1,600 mg

-

-

-

2,000 mg

2,800 mg

4,000 mg

1,200 mg

2,000 mg

2,400 mg

*Dose in mg/kg and (usual dose in mg).

Adult OI Table 6: 

Special Considerations for TB Treatment with HIV Co-infection

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 in 7-36%; clinical features - high fever; increased adenopathy, 

CNS lesions, pulmonary infi ltrates and pleural effusions. Treatment is symptomatic; if severe 

give prednisone 1 mg/kg and reduce dose at 1-2 weeks.

A Pocket Guide to Adult HIV/AIDS Treatment

provides treatment information in table format 

for easy reference in clinical settings:

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

National HIV/AIDS Clinical Consultation Center Warmline: 

1-800-933-3413

(toll free in the U.S.)

Drug Tables ............................... Pages 2-15

Adult ART Tables .................... Pages 16-30

Pregnancy Tables ................... Pages 31-36

Prevention for Providers ...............Page 37

Adult OI Tables ....................... Pages 38-48

Recommendations for HIV care and treatment 

are complex and change rapidly. In addition 

to the Pocket Guide and A Guide to Primary 

Care of People with HIV/AIDS, which the Pocket 

Guide supports, consult the following resources 

provided by the U.S. Department of Health 

and Human Services for frequently updated 

HIV treatment information: