CLINICAL TRIAL: ACTG A5164:IMMEDIATE VS DELAYED ART FOR HIV-INFECTED PATIENTS WI

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a trial from the ACTG to measure the impact of immediate versus delayed initiation of antiretroviral therapy (ART). Protease-based ART is associated with an immune reconstitution inflammatory syndrome. Little about this syndrome is clear. Nor is it clear what the timing of immune reconstitution should be after an AIDS-defining opportunistic infection (OI). This study hypothesizes that initiating ART during the course of treatment of an acute OI will lead to a more rapid recovery from the disease. The primary objective is to compare the outcomes of those with immediate to those with delayed ART with regard to a) survival without AIDS progression and undetectable plasma HIV levels; b) survival without AIDS progression and detectable HIV-1; and c) AIDS progression and death. The secondary objectives look at changes in CD4, safety, quality of life, clinical outcomes of the OI, and the development of ARV resistance in the groups. This is a 48-week study of 282 subjects presenting with a treatable AIDS-defining infection or pneumonia. They are randomized into an Immediate Treatment Group (with ART starting within 2 weeks) or a Deferred Treatment Group (where ART is initiated no earlier than 4 weeks and no later than 32 weeks after starting treatment for the OI). The ART will consist of Kaletra, stavudine, and 1 or 2 additional drugs. A substudy will look at the pharmacokinetics of Kaletra during and after the OI. As there is no consensus on how to treat those with an acute OI with ART, testing the issue of immediate versus delayed (12 weeks) treatment is of clinical significance. Subjects continue to be recruited for this study. No results are available yet.