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Women are different than men

Data on the natural history of HIV disease in women are still limited. In addition to getting many of the opportunistic infections seen in men, women have sex-specific symptoms that are often either hormone-related or gynecological in nature. Recently, information in

several different studies suggests that women have lower viral loads than men, although HIV disease appears to progress at the same rate in both sexes. Women probably differ from men in absorbing, metabolizing, and experiencing the clinical effects of certain medications. Drug dosing, absorption, efficacy, and toxicity are likely to be affected by differences in hormones, weight, and body composition between men and women. Recent findings from ACTG 175 showed that women were more likely than men to develop severe HIV symptoms, that women required their first dose modification sooner than men, and that the length of time to the need for the first dose modification occurred earlier for women.

Furthermore, lack of sufficient data supporting the use of certain antiretrovirals in female patients serves as a barrier to their use for both the patient and the healthcare provider. Considering the complexity of the various possible combinations of antiretrovirals and the relative lack of data available, there is a definite need to further assess the use of these drugs in women. Prior to 1993, women were, for the most part, excluded from participating in clinical trials. Treatment interventions, toxicity, and safety data were studied in men only and then applied to women. In 1993, as a result of pressure from health activists, the Food and Drug Administration (FDA) finally mandated the inclusion of women in clinical trials. Despite this gain, women still only comprise about 12% of the total participants in clinical trials.

By 1996, many questions still remained unanswered about treatment interventions for HIV-infected women, gender-specific toxicities, and safety. Women Alive, a grass-roots organization based in Los Angeles, and created by and for women with AIDS, began organizing with other activist women living with HIV throughout the country. They decided it was time to demand answers from researchers about why there is still life-threateningly limited information concerning women: Why are women still poorly represented in AIDS clinical trials and why is there hardly any information available about the effects of hormones on HIV-infected women? As a result of this pressure and constant and persistent activism, research projects have been developed to look at these issues.

Since the availability of protease inhibitors in 1996, AIDS deaths have declined considerably. Recently, however, reports of new onsets of diabetes, abnormal distribution of body fat, and hyperlipidemia occurring during treatment with protease inhibitorcontaining regimens have received widespread attention. Whether the metabolic disorders are a direct result of PIs, or are due to the effects of HIV on the body over time, is unclear. Considering the complex combinations of antiretrovirals and the serious lack of data, there is a dire need to assess the use of these drugs in women. Not only is it imperative to include women in clinical trials, but we must conduct studies on the effects of HIV antiretrovirals in women.

This year, the AT LAST (Antiretroviral Therapy Looking At Sex and Treatment) study, now underway in several parts of the country, will begin to address some of these issues. The AT LAST study is designed for those patients whose first experience with antiretroviral therapy (ART) has been with a non-protease combination of either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a nucleoside reverse transcriptase inhibitor (NRTI) and who have either developed viral rebound (vRNA >500 copies/mL of rebound over baseline) or in whom one of the above combinations was intolerable or unable to suppress HIV RNA replication.

AT LAST will look at a new formulation of Videx (ddI, didanosine) and will offer Crixivan (indinavir) and Norvir (ritonavir) along with Zerit (d4T, stavudine) and Videx together twice daily. But more importantly, the AT LAST study will evaluate the differences between women and men. Little is known about the impact of IP therapy on hormonal levels in women with HIV/AIDS. The AT LAST trial will examine the impact of a treatment

regimen containing a combination of protease inhibitions on hormones, menstrual cycles, and the impact of hormone levels on the risk of developing metabolic changes.

Women Alive will provide a national peer support advocate (PSA) component throughout the duration of the study. The Women Alive PSAs will conduct peer education, support, and advocacy sessions for participants at each site. The peer support advocate will discuss each study participants needs regarding travel, childcare, practical daily needs and/or any other issue that may affect the persons ability to fully participate in the trial and to adapt to study procedures and/or adhere to an HIV antiretroviral drug regimen.

The history of clinical research in HIV disease has been unusual in many respects. Even more than with other illness, the scientist/clinician and the patient/advocate have crossed paths. Their meeting has produced fascinating, frustrating, and fruitful exchange. People living with HIV and their advocates have demanded changes in the way research is conducted. AT LAST, we have a study for women.

Debra Johnson, NP,PA-C is Clinical Investigator for the USC Clinical Trials Unit/ KECK School of Medicine Clinical Instructor for AETC (AIDS Education Training Center)Primary Care for 450 HIV/AIDS patients

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