Why do we need the GRACE (Gender, Race & Clinical Experience) study?

Women have been greatly and adversely impacted by the AIDS epidemic and worldwide half of the people living with HIV/AIDS are women. In the USA, women of color constitute 80% of those with AIDS. Historically, women have not participated in clinical trials in the same proportion as their case distribution. One of the consequences of this limited representation in clinical trials has been the lack of information on gender-specific manifestations, adverse events, drug interactions and other pertinent data. In addition most studies lack the statistical power to allow for race and/or gender analysis. The US FDA guidelines call for data analysis for sex-related variations in response to drug treatment, including potential pharmacokinetic differences, to enable relevant assessment of pharmacodynamic differences or relationships. Nevertheless, there is little information pertaining to gender and race for most of the approved antiretrovirals. In order to fill this gap and demonstrate that women of color can succes...