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 is a randomized, phase II, three arm, open-label study to compare twice daily and once daily potent antiretroviral therapy and to compare self-administered therapy or therapy administered under direct observation. Each subject will be followed on the study for 48 weeks.This study will enroll 375 subjects: 150 in each of the self-administered treatment arms, and 75 in the DOT arm. The population will consist of HIV-infected subjects who are antiretroviral naive, and who have plasma HIV-1 RNA levels 2000 copies/mL. To ensure balance among the three arms, subjects will be stratified based on screening plasma HIV-1 RNA levels: < 100,000 copies/mL and 100,000 copies/mL. Subjects will be randomized into one of three treatment arms: arm A (BID), arm B (QD), or arm C (QD/DOT). The primary specific aims of this study are to compare the ability of a potent antiretroviral regimen to achieve a sustained virologic response in HIV-1 infected subjects through week 48 when given twice daily and when given once daily, to compare the ability of a potent antiretroviral regimen to achieve a sustained virologic response in HIV-1 infected subjects through week 24 when self-administered and when administered under direct observation, and to evaluate the safety and tolerance of the study regimens. The secondary objectives of this study are to evaluate the treatment response by exploring the impact of a number of different composite virologic and treatment endpoint definitions at weeks 24, 48, and over time, to determine whether antiretroviral activity at weeks 4 and 8 correlates with virologic suppression through week 48, to determine LPV/r trough concentrations (Cmin) in the BID and QD arms, when given in conjunction with d4T XR and FTC, to determine if LPV/r Cmin correlates with virologic suppression at weeks 4 through 48, to evaluate the relationship between adherence and LPV/r Cmin, to monitor unexpected accumulation of LPV/r in subjects receiving QD treatment, to compare LPV/r Cmin in the DOT and non-DOT arms and to determine whether LPV/r PK variability is greater in the non-DOT arm, to compare the virologic resistance mutation profile patterns at the time of virologic failure among subjects in the BID and QD study regimens, to compare CD4+ and CD8+ T-cell responses between BID and QD dosing schedules and between DOT and non-DOT treatment strategies, to evaluate adherence to a DOT program and its impact on virologic response through week 48, to compare the impact of BID and QD dosing schedules and DOT and non-DOT treatment strategies on quality of life parameters and treatment adherence, to explore whether DOT treatment for the first 24 weeks has an effect on quality of life and adherence to study treatment between weeks 24 and 48, to evaluate subject attitude to DOT (for subjects in Arm C), and to explore the feasibility of DOT strategies in a multicenter AACTG trial.
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