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Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
Author(s): Struble, Kimberly A*, Toigo, Theresa A*, Behrman, Rachel E*, Birnkrant,
Debra B*.
*The Food and Drug Administration, Rockville, Maryland, U.S.A.
Objective: To evaluate the proportion of women enrolled in clinical trials of investigational HIV therapies and assess factors that may influence enrollment of women.
Methods: Protocols were identified from a search of the AIDS Clinical Trials Information Service (ACTIS), a database that provides detailed information, including entry and exclusion criteria, on federally and privately sponsored clinical trials for HIV/AIDS therapies initiated between 1989-1994. Demographic and enrollment information was requested by letter from trial sponsors of all protocols.
Results: A total of 221 privately sponsored protocols were identified from the ACTIS database. Sponsors of 156 protocols provided demographic data stratified by gender. Enrollment of women in this sample ranged from 0-64% (mean 11.6%). Twenty four trials enrolled no women. All were in phase 1 or 2 of development. All 24 protocols permitted enrollment of non-pregnant women. Sixteen of 24 studies required some form of birth control, including barrier methods, abstinence, and/or oral contraceptives. Eight of 24 protocols did not specify any reproductive-related inclusion/exclusion criteria. None of the 24 protocols had laboratory-based exclusion criteria that appeared to exclude women.
Conclusion: Factors other than gender-based eligibility criteria appear to be responsible for the failure of women to enroll in this sample of HIV clinical trials. To further explore this, The Food and Drug Administration is developing an HIV investigational new drug database to assess the recruitment and to promote the retention of women in current and future HIV clinical trials.
Address: KA Struble, 5600 Fishers Lane, HFD-530, Rockville, MD U.S.A. 20857
Telephone: 1-301-827-2422 Fax: 1-301-827-2510