ACTG A5073 COMPARE ANTIRETROVIRAL THERAPY & SELF-ADMINISTERED & OBSERVED THERAPY

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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. A5073 is a randomized, phase II, open-label, 48-week, multicenter trial of 375 subjects, designed to compare the antiretroviral efficacy of two dose schedules of a potent multi-drug combination antiretroviral regimen. In one arm one component of the regimen will be given twice daily (BID, arm A) and in another arm, all components will be given once daily (QD, arm B). A5073 also seeks to determine the effect of directly observed therapy (DOT) on antiretroviral efficacy by comparing two treatment strategies for the same QD regimen: conventional, self-administered therapy (arm B) or directly observed therapy (DOT, arm C) for the first 24 weeks of the study. After week 24, subjects in arm C will self-administer all study medications through week 48 in order to examine for a possible training effect of DOT. Plasma HIV-1 RNA levels will be measured frequently throughout the study. Additional outcome measures will include safety and tolerance; quality of life and adherence indicators; and CD4+ and CD8+ T-cell responses. Population pharmacokinetics (PK) will be performed on all subjects. Adherence will be measured throughout the study using an electronic drug monitoring system. Subjects randomized to arm C will be observed for their once daily dose of study medications on a Monday-Friday schedule, and will self-administer the weekend and holiday doses.