The University of Hawaii plans to develop the infrastructure for an AIDS Clinical Trials Unit (ACTU) to study potential therapies for Human Immunodeficiency Virus (HIV) infection and AIDS-related opportunistic infections in Asian/Pacific Islanders and intravenous drug users (IVDUs) infected with HIV. Resources of the University of Hawaii John A. Burns School of Medicine, the NIH-funded Research Centers in Minority Institutions (RCMI)-AIDS Program and the Hawaii State Department of Health will be integrated as a foundation for developing the Hawaii ACTU. The project will be directed by Dr. Margo Heath-Chiozzi who has two years of prior ACTG experience as a co-investigator at the Beth Israel Hospital subunit of the Harvard/Boston City Hospital (BCH) ACTU. The professional and support staff necessary to conduct HIV clinical research will be recruited and trained. The main Hawaii ACTU facilities will be developed at Leahi Hospital, a chronic care community hospital which is a joint facility of the University of Hawaii and the Department of Health. Existing clinical facilities will be utilized at Leahi, Queen's Medical Center which cares for the majority of indigent HIV-infected patients on Oahu, and Kapiolani Medical Center for Women and Children where HIV-infected women and children receive care. Data management, quality assurance, laboratory specimen processing, and investigational drug management capabilities will be developed in collaboration with existing ACTG resources. A Hawaii ACTU Community Advisory Board will be established to address psychosocial and ethnocultural barriers to protocol participation by minorities and will serve as a major recruiting resource for minority patients. A pilot ACTG protocol will be implemented in collaboration with the Beth Israel subunit of the Harvard/BCH ACTU and NIAID. The ultimate goals of this project are to develop new protocols which examine the unique aspects of HIV-infected patients in Hawaii and to demonstrate sufficient clinical trials expertise to compete for regular cooperative support for the conduct of ACTG research.
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