This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study hypothesizes that immediate antiretroviral therapy (ART), initiated within approximately 2 weeks after initiation of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV-1-infected participants being treated for TB by at least 40% by week 48 when compared to deferred ART, initiated at least 8 weeks after initiation of TB treatment. This is a randomized, open-label study to determine whether the strategy of immediate [within approximately 2 weeks after starting treatment for tuberculosis (TB)] versus deferred (8-12 weeks after start of TB treatment) initiation of ART reduces mortality and AIDS-defining events in participants being treated for TB. There will be two steps and two arms in this study. All participants will enter Step 1 within 2 weeks after starting therapy for TB and be randomized either to receive ART within 3 days after enrollment ('immediate' group; Arm A) or to have ART deferred ('deferred' group; Arm B). Participants in the deferred group will enter into Step 2 8-12 weeks after starting TB therapy, when they are about to initiate ART. The primary study endpoint is the proportion of participants who have survived without AIDS progression by week 48. The objectives are as follows: To characterize and predict potential immune reconstitution syndrome. To evaluate the effect of ART on tolerance of TB treatment. To evaluate the effect of immediate versus deferred ART on TB treatment outcome. The pharmacologic objectives will be to determine whether the 600-mg dose of EFV results in adequate PK drug exposure in the presence of rifampin treatment and to investigate the associations between EFV or NVP trough concentrations, virologic response, and toxicities.
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