The University of Hawaii through support from the DAIDS Minority Infrastructure initiative (RFA 90-AI-04) has developed an adult AIDS Clinical Trials Unit (ACTU) in Honolulu on the island of Oahu for the study of therapy for HIV infection and associated opportunistic infections and malignancies in Asian/Pacific Islanders. Resources of the John A. Burns School of Medicine, the Research Centers in Minority Institutions (RCMI) Program, and the Hawaii State Department of Health are integrated to provide infrastructure for the Hawaii ACTU. The project will be directed by Dr. Margo Heath-Chiozzi who has five years of prior ACTG experience. Current procedures will be used for the conduct of clinical trials including data management, quality assurance monitoring, investigational drug management, and laboratory specimen processing. Immunologic and virologic laboratory tests will be conducted in ACTG-certified laboratories at the University of California, Los Angeles. The Hawaii ACTU plans to enroll approximately 80 patients per year in phase II/III antiretroviral studies, opportunistic infection treatment and prophylaxis studies, and Kaposi's sarcoma treatment studies. Outreach strategies will be specifically focused for statewide recruitment from Oahu and the Neighbor Islands of under-represented groups including Asian/Pacific Islanders, injection drug users, women and adolescents. The scientific capabilities of the Hawaii ACTU will be utilized to develop new protocols which examine the unique aspects of HIV-infected patients in Hawaii such as the use of antiretroviral agents in minority patients who have concurrent infections with Hepatitis B or HTLV-I. The professional development of minority investigators from Hawaii will be facilitated through participation on protocol teams and ACTG scientific and resource committees. The goal of this project is to support the adult Hawaii ACTU to participate in ACTG protocols which evaluate new therapies for HIV infection and the multiple sequelae of the immune dysfunction caused by HIV with targeted statewide recruitment of Hawaii's unique minority patients.
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