The Miami staff has successfully designed, conducted, analyzed and reported results of numerous HIV clinical trials including those related to Kaposi's sarcoma; addressed issues about study design including surrogate marker use; successfully enrolled a large number of patients in clinical trials, including patients with Kaposi's sarcoma, women and minority patients; and helped develop the research agenda and operations of the ACTG. The Miami staff has participated in 92 HIV clinical trials involving antiretrovirals, antimicrobials, biologic response modifiers and cytotoxic chemotherapeutics, including 17 Kaposi's sarcoma studies. This effort includes participation in phase I-Ill studies. The Miami unit will enroll 30 patients per year in Consortium studies; the majority of whom will have Kaposi's sarcoma. At least 3 patients will be women and 50% will be minority patients. A broad spectrum of patients will be available, including those with minimal cutaneous disease, moderate to severe cutaneous disease, documented visceral disease and those with no prior therapy. This will be supported by an internal computer tracking and information system, research medical records, data management and quality assurance, and case management to enhance the recruitment of women and minority patients and retention and compliance. All ambulatory studies will be conducted in a clinical research facility with the capacity do to phase I-III studies, administer intravenous medications and which has on site a research pharmacy, phlebotomy suite, accession laboratory, specimen storage capacity, computer and data entry facilities and medical records facilities. The Miami unit also has two strong core resources, 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 Retrovirology Laboratory has the capacity to perform quantitative and qualitative viral cultures, p24 antigen assays, MT-2 cell assays, plasma RNA PCR and genotypic and phenotypic resistance studies, including cloning and sequencing. Finally, the Miami staff will be actively involved in the Consortium, and assist with the development and implementation of it's scientific agenda, the development and implementation of concept sheets and protocol data management and quality control programs and interactions with pharmaceutical sponsors.
| Krown, Susan E; Lee, Jeannette Y; Lin, Lan et al. (2006) Interferon-alpha2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: an AIDS malignancy consortium phase I trial. J Acquir Immune Defic Syndr 41:149-53 |
| Noy, Ariela; Scadden, David T; Lee, Jeannette et al. (2005) Angiogenesis inhibitor IM862 is ineffective against AIDS-Kaposi's sarcoma in a phase III trial, but demonstrates sustained, potent effect of highly active antiretroviral therapy: from the AIDS Malignancy Consortium and IM862 Study Team. J Clin Oncol 23:990-8 |
| Miles, Steven A; Dezube, Bruce J; Lee, Jeannette Y et al. (2002) Antitumor activity of oral 9-cis-retinoic acid in HIV-associated Kaposi's sarcoma. AIDS 16:421-9 |
