Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive
Eligibility Criteria
Inclusion Criteria: HIV-1 infected Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol. Willing to use acceptable forms of contraception Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol. Therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry Require certain medications Current alcohol or substance abuse that, in the opinion of the investigator, may interfere with the study Uncontrolled diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry Diagnosis of or suspected acute hepatitis within 30 days prior to study entry Signs or symptoms of bilateral peripheral neuropathy of Grade 2 or greater at screening Inability to tolerate oral medication Any other clinical condition that, in the opinion of the investigator, may interfere with the study In the first trimester of pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
A
B
Study-specified Antiretroviral regimen under care of HIV-trained medical doctor
Study-specified Antiretroviral regimen under care of HIV-trained primary care nurse