Round Table Session on Interdisciplinary Clinical Trials -- We've Come a Long Way Baby!
Presented at the '99 National Women & HIV Conference
The 1999 National Conference on Women and HIV/AIDS, which took place in early October at The Los Angeles Convention Center, turned out to be a great success! It became the space in which over 1,200 women living with HIV from all over the states were able to exchange all kinds of information between peers, researchers, health care providers, government agencies and community based organizations. There was old news and new news. Yet, all of the information was relevant and important regarding women and HIV disease.
It was refreshing and exciting to hear new developments in the field of clinical trials presented at the roundtable on Clinical Trials and Women. The roundtable took place on Monday, October 11, 1999. During this session, presenters discussed the many strategies on how to include, inform, enroll and maintain women in HIV/AIDS clinical trials.
Historically, women have been systematically excluded from active participation in the early stages of clinical trials. The FDA claimed that the clinical trials were often dangerous to women due to potential pregnancies, and in turn, this could potentially damage the fetus. Usually, the criteria for exclusion read: "no pregnant women, and no nonpregnant women" can participate in this clinical study.
This situation has dramatically changed since the beginning of the 1990's, due primarily to the community pressure that was put on the AIDS Clinical Trials Group (the government-funded body in charge of the nation's AIDS research effort) by women activists from ACT UP and other groups.
The HIV Law Project of New York presented on this very issue. In 1993, the fervent activism of women living with HIV, along with the aid of the HIV Law Project, the N.O.W. Legal Defense and Education Fund, and the American Civil Liberties Union AIDS Project submitted a joint petition to the FDA (Food and Drug Administration) demanding to change their rules and allow clinical trials to include women.
During 1995, The National Task Force on AIDS Drug Development provided the FDA with recommendations to finally include women living with HIV in the early phases of clinical trials, and to stop any clinical trial that prevents the inclusion of women of childbearing potential with life threatening diseases. Later the same year, the FDA changed their criteria to be more inclusive of women. However, to date the FDA has not enforced this regulation, and it gives room for some clinical trials to continue discriminating against women.
The HIV Law Project, which is based in New York City, presented their strategy to pressure the FDA to enforce their own rules. They are developing a consensus statement that will expose the FDA's lax about not enforcing their rule, and further pressure the FDA to hold the pharmaceuticals and researchers responsible to design clinical trials inclusive of all people. The HIV Law Project encourages all who are concerned about this issue, including Community Based Organizations, to sign and support the consensus statement. (The statement was printed in the Summer '99 issue of Women Alive Newsletter) The HIV Law Project finds that "only continuous activism will ensure that federal agencies and pharmaceutical companies will put the needs of people living with HIV/AIDS before politics and profits." If you have any concerns, or would like to support their consensus, call: 212.674.7590.
Another project presented at this roundtable was the Study-Link project under the Clinical Directors Network, a New York based non profit organization. This project provides referrals in person, or via telephone through a computerized database information system on how to enroll potential patients into clinical trials. The Study Link functions as a link between patients and clinical trials. If a clinician or a patient calls the project, a brief health history is submitted, and it is put into the database. The computer program searches for all the information and finds if the caller is eligible for any study. The Study-Link Project has been able to refer about 900 patients to the different clinical studies available in their area. Moreover, the project has been able to develop cooperation between studies and has been able to cross-reference between clinical trials. They also provide extensive information about the different clinical trials available. Educational information and forums are provided to encourage and ensure that women and other minorities can participate in projects that may have a potential benefit in the treatment of HIV infection. (212.382.0699)
While these presentations were of great importance about clinical trials and women, one of the most encouraging and exciting parts of the roundtable was the presentation of Women Alive's participation in an upcoming clinical trial. The exciting news was that there is AT LAST, (Antiretroviral Trial Looking at Sex and Treatment) a national clinical trial looking at the differences in HIV treatments between men and women. The study is the result of a two-year effort by Women Alive, clinical investigators, and the pharmaceutical sponsors Bristol-Myers Squibb and Merck & Co.
The presentation was dedicated to the memory of Debbie Thomas-Bryan, who participated in designing this study, tirelessly advocated for the development of clinical studies geared toward women and designed by women. Debbie passed away last year. However, her memory and her hard work will bear the fruits of the outcome of this study, as well as ensuring that further clinical studies are designed with the needs of women in mind.
The AT LAST study will compare sex differences for viral load suppression, diabetes, abnormal distribution of body fat and elevated cholesterol levels in 100 women and 100 men expected to be enrolled at twelve sites around the country. The study will evaluate the regimen of two nucleoside reverse transcriptase inhibitors (RTI's) which are stavudine (ZERIT, or d4T) + didanosine (VIDEX, or ddI) with two protease inhibitors, which are indinavir (CRIXIVAN) + ritonavir (NORVIR) for patients who have already been treated with other NRTI's and NNRTI's regimens. The duration of the study will be of approximately 48 weeks.
Women Alive felt strongly that in order for women to maintain the study regimen, and to participate fully in the study, a support component was imperative to address the complex needs of women living with HIV. Thus, this clinical trial is unique because it will include a peer support advocate on location at each site to provide ongoing support, education, and advocacy to assist individuals in successfully participating in the study.
The peer support advocate will assess the needs of each participant and will identify potential barriers and provide solutions to these barriers such as transportation, child care and other issues that may hinder their participation. The peer support advocate will coordinate services with the study's Site Coordinators and other participants in the study.
DeAnna Bowens, Women Alive's AT LAST National Peer Advocate Coordinator stated that "We don't want a single person -- woman or man -- to have to drop out of this study due to the demands of day-to-day life. We feel that adherence is so important that our peer advocates will be asked to wear pagers in order to be available at all hours to provide support to patients."
Sites for the Study
The participating sites for the study are in the following cities: New Orleans, Louisiana; Rochester, and New York City, NY; Boston, MA; Berkeley, CA; Newark, NJ; Powel, OH; Atlanta, GA; Chicago, IL; Charleston, SC; Birmingham, AL; and Los Angeles (UCLA and USC), CA. Women Alive is actively seeking Peer Support Advocates for hire. If you would like more information about the study, and/or want to apply for the position please contact DeAnna Bowens, or Ana Rodriguez at Women Alive's Hotline: 1.800.554.4876.
The New Millennium
We've come a long way in the inclusion of women in clinical trials. Not only in the inclusion, but also in the design of sound, comprehensive clinical studies that tailors to the needs of women living with HIV. The roundtable session shows that through activism, collaboration, information, and the participation of women with HIV in designing clinical trials we can further improve the clinical HIV treatment for women, and the quality of life for all women living with HIV.
Perhaps in the new millennium, we will be going to conferences where clinicians and researchers will provide us with answers that make sense, and with enough data and proof instead of... " we don't know at this time, how it affects women," an answer commonly heard throughout the nation at updates, forums and conferences.
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.