Abstract

Despite the prevalence of HIV disease among women, drug trials to date have enrolled mostly men. In drug trial recruitment, HIV-infected women typically suffer quadruple jeopardy: first, they may be excluded because they are either potentially or actually pregnant; second, they may be excluded because they are members of minority groups and lack access to the health care system and to research institutions; third, they may be excluded because they are drug users and are presumed to be noncompliant subjects; fourth, they may be excluded because most of the trials so far have focused on AIDS itself, and many of the women have been infected recently and have not developed a clinical diagnosis ofAIDS. Efforts to enroll women in HIV/AIDS drug trials must surmount the barriers of the regulatory system; the resk-avoidance practices of the pharmaceutical industry; the lack of access to the health care system; the suspicion of many minority communities, based on past abuses, that research presents risks but no benefits; and the needs of women for child care and transportation in order to participate. Women should not be categorically excluded from research, but there may be special, very limited circumstances in which exclusion of pregnant women may be justified.

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