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Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine
Date:9/20/2010

estigator in the GRACE study.  "The GRACE study has the potential to shape how future studies are conducted because it addressed the social and economic barriers that historically have prevented women from participating in clinical research. It also showed that we have a long way to go before we can fully overcome these barriers."

In the United States, women account for an increasing proportion of people living with HIV/AIDS, including more than one quarter of new diagnoses. Yet despite their growing numbers, women have been under-represented in HIV treatment studies. This may be due to recruitment and retention challenges including family commitments, time constraints with jobs, and other socioeconomic factors. These observations have been noted in clinical trials of other therapeutic areas, including heart disease and cancer, suggesting that difficulties in recruiting women are not specific to HIV clinical trials. As a result of having a low number of women in these studies, gender-based conclusions are limited, and there remains a gap in clinical data.

"Unlike most studies of HIV medicines, GRACE was specifically designed and powered to assess gender differences in response to treatment," said Dr. Currier. "We took steps that have never before been used to make sure our study population was reflective of the demographics of women with HIV in the United States."

GRACE Study Design and ResultsGRACE was a multi-center (65 sites), open-label Phase 3b trial that compared the efficacy, safety, and tolerability of the protease inhibitor PREZISTA (600 mg) boosted with a low dose of ritonavir (100 mg) twice a day, in combination with an investigator-selected optimized background regimen for 48 weeks in men (n=142) and women (n=287).  

The study was designed to enroll a high proportion of North American, treatment-experienced women that was reflective of the distribution and demographics of women with HIV in the United States. 
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SOURCE Tibotec Therapeutics
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