PACTG 1034: PROTEASE-CONTAINING AND PROTEASE-SPARING HAART REGIMENS

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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. DESIGN: Phase III, open-label, randomized SAMPLE SIZE: 240 subjects POPULATION: 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. Subjects may be nanve 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 may not have received more than a single regimen in their lifetime with the exception of ZDV monotherapy during pregnancy. Subjects must be nanve to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. STRATIFICATION: All subjects will be stratified by previous antiretroviral exposure (absolutely nanve or antiretroviral exposed). DURATION OF STUDY: Ninety-six weeks.