CLINICAL TRIAL: PACTG 390: ANTIRETROVIRAL REGIMENS AND TREATMENT-SWITCHING STRAT

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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 phase II/III randomized, open-label study of combination antiretroviral regimens and treatment-switching strategies in antiretroviral na¿ve children >30 days and <18 years of age. This pediatric ACTG (AIDS) study will address two major questions: 1) Is initial antiretroviral therapy consisting of 2 nuclear reverse transcriptase inhibitors (NRTI) plus a protease inhibitor equivalent to 2 NRTI plus a non-nuclear reverse transcriptase inhibitor (NNRTI), as measured by the change in viral load between the entry level and the value after 4 years of treatment? 2) Should subjects experiencing a virologic relapse switch to a new regimen at a viral load of 1,000 copies/ml or after the viral load has increased to 30,000 copies/ml? In the second regimen, subjects will receive 2 new NRTI plus either an NNRTI or a protease inhibitor, whichever they had not received in the initial regimen. Stratification will be done by age (<3 years, >3 years), perinatal exposure to antiretroviral therapy, and site (American vs. European). The analysis will consist of intent-to-treat analyses with an analysis of covariance for the various factors in different arms. 256 subjects will be enrolled.