Please select the eligibility criteria that correspond to the clinical trial below.
Title: Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
Brief Summary: In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. Data suggest that aggressive management of HIV infection, which includes Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and mortality. On the other hand, the use of HAART for patients with TB may cause severe complications due to drug-drug interactions, and occasionally a temporary exacerbation of symptoms. These reactions may be particularly severe when HAART is started soon after the start of TB treatment.

The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts.


Options:
A: Inclusion Criteria:

* Aged 16 and more
* Member of a household in the designated cluster within the Hlabisa sub-district of KwaZulu Natal in South Africa
* Able and willing to give written informed consent for trial participation and/or HIV counselling and testing
B: Inclusion Criteria:

* All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

* None.
C: Note: Participants who enrolled in this study prior to Version 3.0 will be offered and allowed to switch to FTC/TDF if they wish. However, participants under the age of 18 cannot receive FTC/TDF through this study.

Inclusion Criteria for Step 1:

* HIV-1 infected
* Currently being treated for OI (including Pneumocystis carinii pneumonia \[PCP\]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex \[MAC\]; cytomegalovirus \[CMV\] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry.
* Able to take oral medications
* Parent or guardian willing to provide informed consent, if applicable
* Willing to use acceptable methods of contraception

Exclusion Criteria for Step 1:

* Any ART within 8 weeks prior to study entry
* 31 or more days of any ARV within 6 months prior to entry
* History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons
* Systemic cancer chemotherapy within 30 days prior to study entry
* Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma)
* Investigational ARV agents at study entry
* Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion
* Anticipated use of certain medications
* Kidney failure requiring dialysis
* Current drug or alcohol use that, in the opinion of the study official, would interfere with the study
* Treatment for current, first-treated, and diagnosed OI or BI for more than 14 days prior to study entry
* Known resistance to ART that prohibits administration of an effective ART regimen
* Current OI has recurred within 90 days prior to study entry. Recurrent BIs are not excluded.
* Pregnant or breastfeeding
D: Inclusion Criteria:

* Age 18 or over
* Positive HIV test result
* CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
* Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
* Naive to ART
* TB treatment started less than one week prior enrolment
* Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause)
* Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom.

Exclusion Criteria:

* Suspected TB with negative AFB
* Pregnant or breastfeeding women
* Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
* Unable and/or unlikely to comprehend and/or be adherent to the protocol
* Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial

Answer: D