Thursday, July 28, 2011

HIV researcher plans new PrEP study

via Chelsea Now, By Sam Spokony

[One major factual error in that article: “The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks.” For example in iPrEx, average follow up was 14 months. Otherwise, a very informative article.]

Few methods of HIV prevention have been as promising, or as controversial, as pre-exposure prophylaxis (PrEP). After a history of underground practice and off-label prescriptions, the approach has recently begun to receive serious attention from researchers, policy makers and health care advocates.

Under the guidance of Dr. Roy Gulick (director of the Weill Cornell Medical College HIV Clinical Trials Unit), a new experiment called the NEXT (Novel Explorations of Therapeutics) PrEP Study will begin this fall. It will include 400 at-risk, HIV-negative gay men, and will take place over 48 weeks at 12 sites across the U.S. and Puerto Rico.

The NEXT PrEP Study will differ from iPrEx in that its primary experimental group will receive a daily regimen of the drug maraviroc (brand name Selzentry). The control group will receive Truvada, and two other experimental groups will receive combinations of maraviroc and either tenofovir or FTC (the two individual drugs that make up Truvada). A major goal of the study, along with testing the HIV-prevention efficacy of maraviroc, will be to gauge the side effects of the drug on participants.

“The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks,” Gulick told Chelsea Now in a July 23 phone interview [This is inaccurate. The guys in iPrEx, for instance, were followed about 14 months - LifeLube]. “Now, since this is a drug we’re giving to healthy people, the next step is exploring further to prove that it is both safe and tolerable for them.”

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