Research
By Chris Bournea
An innovative study is comparing how HIV-positive women respond differently to medication than their male counterparts. The Gender, Race and Clinical Experience (GRACE) study was launched last fall to compare how women and men respond differently to the drug Prezista darunavir) and antiretroviral agents. The groundbreaking study is also exploring racial differences in treatment outcomes. “Women and people of color have been under-served in clinical research,” said Dawn Averitt-Bridge, founder and board chair of The Well Project, which provides access to health resources for women diagnosed with HIV and AIDS. “This clinical trial is really exciting because both gender and race are finally being considered.” Women account for almost 30 percent of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color, according to GRACE study researchers. However, women have been underrepresented in HIV clinical trials despite research suggesting that women may have different tolerability issues to HIV medications than men. “GRACE is a landmark study because HIV treatment trials -- including those looking at treatment-experienced populations -- have traditionally included very small numbers of women, especially in the earliest studies of new antiretroviral agents,” said Judith Currier, M.D., associate director of the University of California, Los Angeles, Center for Clinical AIDS Research and Education and a lead investigator in the GRACE study. “We know that there are gender-specific complications associated with HIV disease. However, we do not know a great deal about how gender impacts the efficacy and side effects of HIV medications.” The GRACE study includes 63 sites in the United States, Mexico and Canada, with an enrollment goal of 420 participants -- 70 percent of whom are women. “Women who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women,” Averitt-Bridge said. Deneen Robinson, a columnist for BlackAIDS.org and African-American woman who has enrolled in GRACE, said the study is the first of its kind to specifically address the needs of women and minorities. “The GRACE study is important for African-American women because it offers the first opportunity for the majority of the participants to represent two important groups in HIV -- women and African Americans,” Robinson said. “The study will show us for the first time if there are any unique differences in HIV treatment for these two groups. This study will begin answering for the larger African-American community about the benefit of therapy for ‘us.’ It will also answer whether or not we have different needs versus other races when it comes to treating HIV disease. Finally, we will have evidence that women, African Americans and inexperienced researchers can participate effectively in research when barriers are addressed.” In addition to involving a record number of women and African Americans, another innovative aspect of the GRACE study is that almost half of the study sites are in Southern U.S. states.
While the South represents a little a more than one-third of the U.S. population (38 percent), it now accounts for 40 percent of people estimated to be living with AIDS and 46 percent of the estimated number of new AIDS cases, according to the Southern AIDS Coalition.
The GRACE study encompasses “sites that are not the usual sites people go to do clinical research. If we wanted to reach out to people who were not enrolling in clinical trials, we had to reach out,” Averitt-Bridge said. “We had to consider bringing the clinical trials to them instead of just going to the large academic institutions. Some of the large academic institutions do a good job of enrolling minorities and women, but not all of them.”
The GRACE study is sponsored by Tibotec Therapeutics Clinical Affairs, which developed Prezista and markets the drug in the U.S. Study participants receive Prezista along with ritonavir and other antiretroviral agents. Enrollment period for GRACE was November 2006 to November 2007. “The last patient should be enrolling by the first of November,” Averitt-Bridge said. “The first findings will probably be at the International AIDS Conference next summer.”
The International AIDS Conference will be held Aug. 3-8, 2008, in Mexico City. The study will also be discussed at the U.S. Conference on AIDS, sponsored by the National Minority AIDS Council, to be held Nov. 7-10 (2007) in Palm Springs, Calif.
More in-depth findings from the GRACE study will be unveiled at the Conference on Retroviruses and Opportunistic Infections in February 2009.
For more information about the GRACE study, visit www.clinicaltrials.gov, call 1-866-512-7943 or
Chris Bournea is a reporter for ThisWeek Community Newspapers in Ohio.