P1034 10

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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. The study is a multicenter Phase III, open-label, randomized clinical trial that will compare two HAART strategies in HIV-1 infected adolescents (i) the effects of a PI-based HAART regimen versus an NNRTI-based HAART regimen on virologic outcome and (ii) the effects of therapeutic drug monitoring (TDM) versus no TDM on virologic outcome. HIV-infected adolescents, regardless of route of infection, who are 13 to 23 years of age with HIV RNA >10,000 copies/ml and for whom antiretroviral treatment is felt to be indicated by a subject's primary care provider will be enrolled after consent is obtained. Eligible subjects may be na¿ve to antiretroviral therapy, or may have received a single regimen of combination therapy, consisting of NRTIs with or without a single PI (except lopinavir). They however may not have received more than a single regimen in their lifetime with the exception of ZDV monotherapy during pregnancy, and they must be na¿ve to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. Another component of the study will examine therapeutic drug monitoring (TDM) in the cohort. Subjects will be randomized to TDM or no TDM arm at the time of randomization. For the two randomized comparisons of PI-containing HAART regimen versus PI-sparing regimen and TDM versus no TDM, the primary endpoint is the rate of virologic suppression while on the assigned study therapy between 24 and 48 weeks after randomization.