This study is a multi-center four-arm, randomized, double blind study designed to determine the relative efficacy of two regimens of combination nucleoside antiretroviral therapy, a regimen of monthly alternating nucleoside therapy, and a triple-drug combination regimen for improving survival in HIV-infected persons with advanced disease [CD4 less 50/mm(3)]. Howard University proposes to enroll 80 patients. Patients will be randomized to one of four study arms and will be seen at study entry, week zero, and then every four weeks. The major study endpoint is survival; therefore, data will be collected until the patient's death. The patient's tolerance of the study regimen and clinical course are secondary endpoints. This trial is one of several antiviral trials for HIV that the investigators are conducting or are planning to conduct. The investigators have already enrolled 43 patients in the study, eight of which have required hospitalization (three were hospitalized twice). These eight patients accounted for 79 study-related hospital days. This study, and similar studies would benefit tremendously from a GCRC at Howard University Hospital. Resources such as skilled research nurses and pharmacists would enhance our current monitoring, drug delivery, and management systems. The presence of a GCRC would also allow us to expand our research efforts to include the conduct of phase I studies, which require careful and intensive monitoring. Another advantage of a GCRC would be the ability to perform viral cultures and other research-related tests on site, thereby promoting collaboration between laboratory and clinical research.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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