The Clinical Core of the UAB CFAR was established in 1988 to provide a bridge between patients attending the AIDS Outpatient Clinics (1917 Clinic and the Family Clinic) and the basic scientists working in the laboratories of the Center. The Center provides support to investigators through a clinical database, a clinical specimen repository, clinical trials, and ongoing programs in clinical pharmacology. The clinical database maintains quality assured clinical data on all outpatients seen in both the adult and children's HIV Outpatient Clinics. Baseline demographics along with critical clinical information is stored in a centralized computer. Blood specimens are collected on a periodic basis and stored in a central specimen repository. This repository has a computerized record of every specimen collected over the five years of clinical core's existence, yielding easy retrievability of specimens desired for a specific basic science or clinical science study. The specific objectives of the Core are to: (1) establish and maintain effective communication between clinical and basic scientists in order to develop multidisciplinary collaborative projects which study the nature and pathogenesis of HIV disease; (2) provide clinical specimens from well-characterized patients to basic science investigators through the establishment of a clinical specimen repository which is linked to a computerized database; (3) conduct state-of-the-art clinical trials on novel therapeutic agents and regimens for HIV-related disorders; (4)link the clinical trials effort with development of novel markers of anti-retroviral activity, new approaches in investigative pharmacology, and the discovery of new agents through an ongoing drug discovery program and experimental therapeutics program. The Clinical Core has been extremely successful, providing service to 46 CFAR investigators on over 100 specific projects. The Center has conducted 46 clinical trials, focusing on primary infection (369 patients enrolled), opportunistic infections (222 patients enrolled), and nutritional/cytokine studies (66 patients enrolled). These studies have encompassed the full range of trial designs from Phase I early pharmacokinetic studies to Phase III multicentered clinical efficacy trials. Future directions include the establishment of a Vaccine Evaluation Unit, an Outpatient Dental Facility for the Study of HIV-related oral disease, to modify the clinical database to provide a foundation for studies in behavioral science, and to develop a Women's Clinic for studies of HIV- related disease occurring in this population.
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