The Miami ACTU staff have successfully designed, conducted and participated in all aspects of HIV clinical trials; addressed critical questions about the treatment of HIV infection including early treatment intervention and combination therapies; addressed critical questions about study design including the use of surrogate markers; successfully enrolled a large number of patients in clinical trials, including women and minority patients; and helped develop the research agenda and priorities of the ACTG. The Miami ACTU staff have participated in 90 HIV clinical trials, including the evaluation of antiretrovirals, antimicrobials, biologic response modifiers and cytotoxic chemotherapeutics. This effort has encompassed participation in phase I-III studies. More recently, the Miami ACTU staff have been involved in the assessment of viral load, viral phenotype and drug resistance in assessing long-term clinical outcome in patients with advanced and early HIV disease (ACTG 116A, 175 and 241), and designed the first study in the ACTG to stratify for viral phenotype in order to evaluate potential treatment differences in patients with syncytium inducing versus non-syncytium inducing viruses (ACTG 259). The Miami ACTU will enroll 100 patients per year in ACTG studies and follow each year an additional 120 patients who were enrolled in previous years. Through case management and community outreach programs, approximately 20% of the patients to be enrolled will be women and 60% will be minority patients. A diversity of patients including those at all stages of HIV disease, those who are antiretroviral naive and experienced, and those with a wide variety of opportunistic infections and Kaposi's sarcoma will be available. Recent collaborations with Neurology will make available patients with neurologic complication of HIV. Our clinical trials effort is supported by an internal computer tracking and information system, a research medical records system, data management and quality assurance, and case management to enhance the recruitment of women and minority patients and to enhance retention and compliance in clinical trials. All ambulatory studies will be conducted in a clinical research facility with the capacity to do phase I-II studies and which has an on-site research pharmacy, phlebotomy suite with accession laboratory, specimen storage capacity, computer and data entry facilities, medical records facilities, and conference room. In addition, the Miami ACTU has two strong core resources, including a Clinical Immunology and Retrovirology Laboratory. The Clinical Immunology Laboratory has the capacity to do monoclonal analyses of leukocyte phenotypes, serum and plasma soluble markers, lymphocyte and monocyte mRNA RT PCR, lymphocyte proliferation and lymphocyte cytotoxicity. The Clinical Immunology staff has expertise in adoptive cell transfer and cell therapies. The Retrovirology Laboratory has the capacity to receive, process, store and ship specimens and perform qualitative culture, quantitative cell dilution microculture, MT-2 assay, serum/plasma p24 antigen and ICD quantitations, drug susceptibility, detection of RT mutation 215 by selective PCR, detection of RT mutations by direct DNA sequence analysis of PCR amplified products, HIV-1 RNA quantitation, HIV-1 DNA PCR, quantitation of cell-free infectious virus by plasma dilution microculture and culture assays to quantitate levels of HIV-1 neutralizing antibody and antibodies to specific HIV proteins by radioimmune assay. The Miami ACTU will be actively involved in the ACTG, including the development and implementation of its scientific agenda, data management and quality control programs and interactions with pharmaceutical sponsors.
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