Tuesday, February 06, 2007

Drug maker Tibotec is recruiting black, HIV-positive women for a study assessing race and gender differences in drug response


The company, a division of Ortho Biotech Products, said its GRACE (Gender, Race And Clinical Experience) study is designed to evaluate treatment-experienced adult women with HIV to see if there are significant variations in the way people of different races and genders respond to HIV medications.

The GRACE study -- open to men and women of all races -- is a multi-center, open-label phase 3b trial that will compare gender differences in the efficacy, safety and tolerability of Tibotec's drug PREZISTA (darunavir) tablets taken in combination with ritonavir and other anti-retroviral drugs over a 48-week treatment period.

The study also will assess racial differences in treatment outcomes.

"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents," said study investigator Debbie Hagins, clinical director of outpatient services at a Ryan White-funded clinic based in Savannah, Ga, "We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications."

African-American Women Who Have Received HIV Treatment Are Sought to Participate in GRACE Study


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