HIV/AIDS Clinical Trials
& Women

Written by David Mariner with help from Mark Baker, Catherine McCartin, and Claire Rappoport

What We Know

• Women make up one quarter of the population estimated to be living with HIV OR AIDS in the United States, or approximately 200,000 to 225,000 women. ¹

• Women comprise a growing share of new AIDS cases each year. The proportion of AIDS cases among women has more than tripled since 1986 from 7% to 23%. ²

• Women of color are disproportionately impacted. Although African American woman represent only 13% of the US female population, they account for almost two-thirds of new AIDS cases report among woman in 1999. Similarly, Latinas accounted for 18% of new cases among women in 1999, but only 11% of the US Population. ³

Women and Clinical Trials

• Before 1993, women were often excluded from clinical trials. Researchers often cited concerns about pregnancy not wanting to cause harm to a fetus. In 1993, however, the Food and Drug Administration said woman could no longer be kept out of trials.

• Women are still underrepresented in HIV/AIDS clinical trials. One analysis of 49 antiretroviral therapy trials conducted between 1990 and 2000 showed an average of 12.25% of women in trials. ⁴

• Eligibility criteria may make it more difficult for woman to enter into clinical trials. The Women's Independent Health Study is currently the largest database of women with HIV in the United States, with over 2,600 HIV positive and HIV negative women. Over 80% of the WIHS trial participants, however, would be ineligible to participate in a typical AACTG trial due to illness, concomitant medications, and psychiatric conditions. ⁵

Gender Differences

• Because there has not been as much research, there is a lot we don't know about women and HIV. Some areas that are of particular interest to woman include: hormone levels, lipodystrophy, gynecological care, and bone loss. For more information, an excellent brochure 'Treatment Issues for Women' is available from the AIDS Community Research Initiative (www.acria.org)

The Role of the Community

• In many studies, women must agree to use birth control if they have sex with men. Pregnant or nursing women usually can't join a trial of an untested drug because it is not known if the drug might harm the baby.

• Some women think they must have an abortion if they become pregnant while in a study; this is not true.

• Every clinical trial has requirements about who can join. If a woman meets these requirements, she can join.

1. Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, July 2000; Centers for Disease Control and Prevention, HIV/AIDS Surveillance Report, Year-End Edition, Vol. 11, No. 2, 1999
2. Centers for Disease Control and Prevention, HIV/AIDS Surveillance Report, Year-End Editions, 1986, 1999
3. Centers for Disease Control and Prevention, HIV/AIDS Surveillance Report, Year-End Edition, Vol 11, No 2, 1999; Urban Institute estimates of the March 200 Current Population Survey, US Bureau of the Census for the Kaiser Family Foundation.
4. MA Pardo, MT Ruiz, A Gimeno, L Navarro, A Garcia, MV Tarazona, MT AZNAR, Gender Bias in clinical trials of AIDS Drugs, presented at the Fourteenth International AIDS Conference, July 2002.
5. R. Greenblatt, Natural History of HIV-1 Infection in Women - - Findings from the Women's Interagency HIV Study, presented at the 10th Conference on Retroviruses and Opporunistic Infections, Feb 2003.