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The Body Covers: The 10th Conference on Retroviruses and Opportunistic Infections

HIV-Positive Women in Clinical Trials: Important, But Underrepresented

Coverage provided by Timothy Wilkin, M.D., M.P.H.

February 12, 2003


Dr. Greenblatt from University of California-San Francisco presented highlights from the Women's Interagency HIV Study (WIHS). This cohort has yielded the largest database on women with HIV in the United States. This ongoing study enrolled over 2,600 HIV-positive and HIV-negative women in 1993-1994 as well as an additional group of women in 2000-2001. There are six participating clinics in urban areas across the country mirroring the racial diversity of HIV-infected women in this country. Women are evaluated in detail every six months. Included are a gynecological exam, physical and dental exam, neurologic and psychiatric testing, and body composition testing. The study has been modified over the years to address emerging concerns in the care of HIV-infected individuals such as lipodystrophy and osteoporosis. Most of the information discussed by Dr. Greenblatt has been published previously.

Women in the WIHS cohort commonly have a history of domestic violence, with two-thirds experiencing it at some point in their lifetime and 20 percent experiencing it recently. Thirty percent had a history of childhood sexual abuse, and these women were more likely to have problems with drug abuse and psychiatric problems. This data identifies intimate partner violence as an ongoing problem among HIV-positive women for which clinicians should screen on a routine basis. These issues are important to address in order to help HIV-infected women maximally participate in their health care.

As we all know by now, women have been underrepresented in HIV clinical trials. It was thought that women's unique social responsibilities make it difficult for them to participate in trials. However, Dr. Greenblatt found that the criteria used to determine if a person is eligible for a clinical trial might also exclude large numbers of women. Using the exclusion criteria from a recent large study from the AIDS Clinical Trial Group, over 80 percent of women in the WIHS cohort would have been ineligible mainly due to other illnesses, concomitant medications, and psychiatric conditions. She suggested that as a result of these exclusion criteria, these clinical trials are not representative of women with HIV today. A full report of this analysis will be enormously helpful for people planning clinical trials and will hopefully prompt a re-evaluation of participant selection so that the results are relevant to all HIV-infected individuals.

Dr. Greenblatt went on to highlight the importance of biologic sex in medical experiments even when studying cells in a test tube. For example, a cell's CCR5 receptor density (a marker for its susceptibility to HIV infection) is influenced by progesterone (a female hormone). She identified how biologic sex affects many steps inside cells in the body -- especially cells of the immune system.

Looking at women in the WIHS cohort over time has shown how much they have benefited from highly active antiretroviral therapy, as is evidenced by the dramatic fall in women's death rate from AIDS. The WIHS cohort is continuing to provide new information on issues such as lipodystrophy, hepatitis C, human papillomavirus infection, and pre-cancers of the cervix, helping to improve the medical care of HIV-infected women everywhere.


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