AIDS ASSOCIATED MALIGNANCIES CLINICAL TRIALS

Project: Research project

Description

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.
StatusFinished
Effective start/end date9/30/957/31/00

Funding

  • National Institutes of Health: $223,778.00
  • National Institutes of Health: $187,434.00
  • National Institutes of Health
  • National Institutes of Health

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Acquired Immunodeficiency Syndrome
Clinical Trials
Kaposi's Sarcoma
Neoplasms
Lymphocytes
Allergy and Immunology
Skin Diseases
Medical Records
Operations Research
HIV
Forms and Records Control
Polymerase Chain Reaction
Phlebotomy
Computer Systems
Case Management
Patient Compliance
Plasma Cells
Research
Information Systems
Quality Control

ASJC

  • Medicine(all)