NEXT-PrEP: A New Study of Maraviroc for HIV Prevention
On the heels of Monday’s FDA approval of the drug Truvada for pre-exposure prophylaxis (PrEP), the HIV Prevention Trials Network (HPTN) today announced a new PrEP study evaluating a different antiretroviral drug for HIV prevention. The study, known as HPTN 069, will assess whether the CCR5 antagonist drug maraviroc (Selzentry) is safe and effective when taken daily to prevent HIV infection in gay men and other men who have sex with men.
Below is an excerpt from the HPTN media release.
HPTN Launches Novel PrEP Study
The HIV Prevention Trials Network (HPTN) is pleased to announce the launch of its latest pre-exposure prophylaxis (PrEP) study. HPTN 069, also known as NEXT-PrEP (Novel Exploration of Therapeutics for PrEP), is the first clinical trial to test whether the drug maraviroc currently approved to treat HIV infection is also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection.
Several PrEP efficacy studies have been completed or are underway around the world but to date all have involved tenofovir (TDF) either alone or in combination with emtricitabine (FTC). Despite encouraging findings from several of these studies, some concerns exist. . . . suggesting that a wider array of antiretroviral drugs should be examined for HIV prevention.
HPTN 069 will enroll 400 HIV-uninfected men who have sex with men (MSM) ages 18 and older in 12 cities in the United States and Puerto Rico (Baltimore, MD; Boston, MA; Chapel Hill, NC; Cleveland, OH; New York City, NY; Los Angeles, CA; Philadelphia, PA; Pittsburgh, PA; San Francisco, CA; San Juan, PR; Seattle, WA and Washington, D.C.). The volunteers will be randomly assigned to take one of four PrEP candidate regimens daily for 48 weeks; maraviroc (300 mg), maraviroc (300 mg) plus emtricitabine (200 mg), maraviroc (300 mg) plus tenofovir disoproxil fumarate (300 mg), or emtricitabine (200 mg) plus tenofovir disoproxil fumarate (300 mg). Matching placebo pills will be added to the regimens so that neither the participants nor the study team will know who is taking which regimen. The study will examine drug adherence among participants and observe for any potential side effects. As part of the study participants will undergo regular HIV testing and will receive condoms and counseling on how to reduce their HIV risk. The study is expected to last approximately two years. . . .
Although the trial is listed as “not yet recruiting,” further details about the study—including eligibility criteria for participating in it—are available here through the ClinicalTrials.gov database.