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New HIV Study Shows That Large Numbers of Women and People of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies
Date:7/20/2009

BRIDGEWATER, N.J., July 20 /PRNewswire/ -- Data from a historic HIV study demonstrate that it is possible to recruit large numbers of women, African Americans and Latinos into U.S.-based HIV-1 treatment studies. The study, known as GRACE, is the largest study to date in treatment-experienced adult women with HIV-1 to examine gender and race differences in response to an HIV-1 therapy -- PREZISTA(R) (darunavir) coadministered with ritonavir as part of combination therapy. GRACE findings were presented today at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) in Cape Town, South Africa.

In the United States, women are increasingly affected by HIV/AIDS, accounting for more than one quarter of all new HIV/AIDS diagnoses, with African American and Latina women representing 79 percent of women living with the disease. Despite the increasing numbers of women with HIV, they have been under-represented in clinical treatment studies. In recent HIV studies of treatment-experienced patients, women accounted for less than 11 percent of the patients being studied, on average. GRACE was able to enroll 67 percent women and 84 percent people of color.

The GRACE (Gender, Race And Clinical Experience) study demonstrated that through 48 weeks of therapy, there were no statistically significant differences in virologic response rates between treatment-experienced women and men receiving the protease inhibitor PREZISTA (600 mg twice daily with 100 mg ritonavir), with a background regimen. In addition, there were no clinically relevant gender-based differences in adverse events.

"GRACE not only showed us that PREZISTA/r had similar efficacy and tolerability in treatment-experienced men and women, but it also taught us that through unique recruitment and retention strategies, a large number of wome
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SOURCE Tibotec Therapeutics
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