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CHICAGO — For years, HIV researchers and advocates have worked toward a gold-standard method of HIV prevention that is more effective than condoms, a robust HIV-prevention pipeline that features a variety of investigational medications and novel delivery methods, and advances that no one could have predicted.

 

“We worked for decades to get to this place,” Jim Pickett, director of gay men’s health at the AIDS Foundation of Chicago, told Medscape Medical News.

 

But “this place” is complicated. With the success of the combination of tenofovir and emtricitabine (Truvada, Gilead) in clinical trials, the World Health Organization and the Centers for Disease Control and Prevention now recommend pre-exposure prophylaxis (PrEP) for all people at high risk for HIV. And regulatory agencies around the world are beginning to consider or have approved the drug.

 

This means the design of next-generation HIV-prevention trials has to change.

 

To that end, statisticians, trial designers, regulators, and advocates gathered during a noncommercial satellite-conference panel here at HIV Research for Prevention (HIVR4P) 2016 to discuss the complexity of organizing clinical trials in the era of highly effective PrEP.

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