The Largest US Study on HIV Treatment In Women
GRACE trial to explore gender-related differences in response to PREZISTA-based HIV therapy
Tibotec Therapeutics Clinical Affairs, a division of Ortho Biotech Clinical Affairs, LLC, announced today the initiation of the largest clinical study conducted to date in treatment-experienced adult women with HIV to evaluate gender differences in response to an HIV medication.
GRACE (Gender, Race And Clinical Experience), a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
There is an urgent need to conduct clinical trials designed specifically for women with HIV. The ratio of women to men among Americans diagnosed with HIV has grown substantially since the HIV epidemic first emerged.
Today, 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. 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