COMPARE TWICE DAILY POTENT ANTIRETROVIRAL 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. The study for HIV-infected subjects will compare the safety and efficacy of self-administered once daily, twice daily, and once daily supervised dosing of three anti-HIV drugs. Two nucleoside reverse transcriptase inhibitor drugs and one combination protease inhibitor will be provided to subjects in pill containers with electronic monitoring devices to record the time and date of each opening of the container. Subjects will be randomized to one of three study arms. All subjects will take emtricitabine (FTC) and stavudine (d4T XR) once daily. Those in group A will also take Kaletra twice daily and those in group B will take Kaletra once daily. Group C subjects will also take Kaletra once daily, but under direct supervision for the first 6 months. A total of 375 subjects will be enrolled. Subjects will have up to 13 visits over 48 weeks. Evaluations will include laboratory testing, physical exams, medical and medication histories, and questionnaires.