AEGiS-07IAC: Women and minorities have less access to AIDS drug trials.

7th International AIDS Conference

Florence, Italy — June 16-21, 1991

Women and minorities have less access to AIDS drug trials.

Int Conf AIDS 1991 Jun 16-21; 7:460 (abstract no. W.D.4291)
D'Eramo JE, Kirschenbaum DZ, McCarthy M, Davis T; AIDS Treatment Resourcces (ATR), New York, NY - USA

OBJECTIVE: To determine whether women, African-Americans, Latinos and intravenous drug users (IVDU's) were less likely to be enrolled in certain AIDS Clinical Trial Group (ACTG) protocols than white males and to determine whether they were concentrated at certain trial sites.

METHODS: Demographic analysis of data gathered from National Institute of Allergy & Infectious Diseases (NIAID) demographic statistics of enrollment by site and ACTG protocol, and the Centers for Disease Control (CDC) AIDS surveillance data.

RESULTS: Of 11,696 adults enrolled in trials, almost all women, African-Americans, Latinos and people with a history of intravenous drug use (IVDU) were enrolled in only 11 of 107 trials. Most sites were enrolling primarily white males with other populations concentrated at just a few sites. The national ACTG enrolled 93.3% men, 6.7% women, 76.5% white, 10.2% African-American, 12.1% Latino and 11.8% IVDUs as of Dec. 18, 1990 at 33 adult ACTG sites. As of Nov. 30, 1990, the CDC reports AIDS cases to be 90.2% men, 9.8% women, 54.9% white, 28.3% African-American, 15.9% Latino and 28.5% IVDUs. 11 (of 107) trials with 48.3% of ACTG enrollment (adults) accrued 78.1% of the women, 74.3% of the African-Americans, 68.8% of the Latinos and 76.3% of the IVDUs. These trials were 4 large AZT trials (002, 016, 019, 020), 3 large ddI trials (116, 117, 118), 2 PCP prophylaxis trials (021, 081), 1 PCP treatment trial (031) and 1 fungal prophylaxis trial (981). Of 33 sites, 15 enrolled over 20 women. The women at these 15 sites account for 71.0% of all women enrolled in ACTG trials. 9.8% of CDC-defined AIDS cases are women, and only 7 sites had female enrollment over that percent. 14 sites had enrolled over 40 African-Americans. The African-Americans at these 14 sites account for 66.2% of all African-Americans enrolled in ACTG trials. Only 1 site had over 28.3% (the percent of cumulative CDC defined AIDS cases who are African-American) of their enrollees who were African-American. Enrollment of Latinos and IVDU's was also examined.

CONCLUSION: Women and minorities have much less access to ACTG trials by protocol. Most sites fail to enroll these populations in proportion to the incidence of AIDS in these respective communities.

Keywords: AEGIS, Anti-HIV Agents, Whites, Blacks, Hispanic Americans, Acquired Immunodeficiency Syndrome, Clinical Trials, Caucasoid Race, Substance Abuse, Intravenous, Centers for Disease Control and Prevention (U.S.), Demography, Zidovudine, Didanosine, Incidence, Human, Female, Male, Adult, ICA7
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