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FDA Approves New Medication for HIV Prevention Study

July 20, 2012

A new study will test three maraviroc-based regimens to evaluate the HIV drug's use to prevent infection in healthy people at risk of the virus. The National Institutes of Health (NIH), whose announcement followed the Food and Drug Administration's approval Monday of the HIV treatment Truvada for pre-exposure prophylaxis (PrEP), is funding most of the study.

Researchers will test maraviroc (Selzentry) in HIV-negative gay and bisexual men, with an aim of 400 participants enrolled in the United States and Puerto Rico. Volunteers in the placebo-controlled trial will be assigned to one of four regimens -- three with maraviroc, and one with Truvada -- for 48 weeks.

Selzentry gained US approval in 2007 and works by inhibiting a pathway HIV uses to infect cells in most newly diagnosed patients. NIH said study leaders want to test other drugs for PrEP due to concerns about possibly serious side effects from Truvada and other previously tested drugs. They also worry about the emergence of drug-resistant viral strains; this has not been widely seen with Selzentry to date.

Drugmakers Gilead Sciences Inc. and ViiV Healthcare will donate Truvada and Selzentry, respectively, to the study. Roy M. Gulick, infectious-diseases division chief at Weill Cornell College in New York, will lead the trial.

Back to other news for July 2012

Excerpted from:
Wall Street Journal
07.18.2012; Jennifer Corbett Dooren

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