The Miami ACTG has successfully designed, implemented and participated in all aspects of clinical trials research through the ACTG; successfully enrolled a large number of patients in these trials, including women and minority patients; and helped develop and establish the research goals and priorities of the ACTG. The Miami ACTG will continue to actively participate in the design, implementation, conduct, analyses and presentation of ACTG clinical trials. 150 patients will be enrolled in the first year and 210-250 patients from previous yrs enrollment will be followed. It is anticipated that 10-20% of the patients enrolled will be women and 45-55% will be minority patients. Approximately 55% of the patients will be enrolled in primary infection studies, 30% in opportunistic infection studies, 14% in HIV-related malignancy studies and 1% in neurology studies. Thus, approximately 60% of the patients will be enrolled in phase III studies and 40% in phase I/II studies. This effort is supported by an internal computer tracking and information system; an internal research medical records system; a data management and on site quality assurance program; and a case management program designed to increase enrollment of women and minorities and to enhance adherence. All ambulatory ACTG clinical trials will be conducted in a new clinical research facility with an on site research pharmacy, phlebotomy suite, and reference laboratory with specimen storage capacity. The investigators have designed and participated in over 30 single or multicenter studies and have considerable expertise in HIV clinical trials. The Miami ACTG has two strong core resources, virology and immunology, which will add to its ability to evaluate virologic markers, quantitative viral assays, drug resistance, leukocyte markers and soluble factors with clinical outcome.
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