GRACE study reports colored women are poorly represented in HIV drug trials

Enrollment of women in clinical trials of new anti-HIV drugs is extremely low, representing only about 15% of all treatment-experienced patients. For women of color it is even lower. Why women, and especially women of color, are so poorly represented in HIV drug trials is the focus of an important article in AIDS Patient Care and STDs, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the AIDS Patient Care and STDs website at http://www.liebertpub.com/apc.

HIV-infected individuals that participated in the GRACE study, conducted from October 2006-December 2008, received antiviral therapy based on a darunavir/ritonavir drug cocktail. More than half of the trial participants completed a survey between 2010-2011 to evaluate their experiences, opinions, and outcomes. The survey showed that 76% of the respondents felt that the GRACE trial made them feel differently about their health/HIV care, 82% became more focused on their health, and 87% continued treatment after GRACE.

Access to treatment was reported as the most positive factor in patient enrollment, according to authors Kathleen Squires and colleagues from Jefferson Medical College of Thomas Jefferson University (Philadelphia, PA), University of Cincinnati College of Medicine (OH), The Well Project, Inc. (Nellysford, VA), University of California, Los Angeles, Janssen Research & Development, and Janssen Services (Titusville, NJ).

Factors associated with difficulties in adherence to HIV medications, a critical part of maintaining healthy lives, included being the primary caregiver for children, unemployment, and transportation difficulties. These findings were reported in the article "Insights on GRACE (Gender, Race, and Clinical Experience) from the Patient's Perspective: GRACE Participant Survey."

"Identification of patients at high risk for suboptimal clinical trial outcomes through surveys such as these should help improve HIV medication compliance and retention," says Editor-in-Chief Jeffrey Laurence, MD, Director of the Laboratory for AIDS Virus Research at Weill Medical College of Cornell University, New York, NY.