Long-acting injectable PrEP study now enrolling
Research sites across the United States (and South America, Asia, and South Africa) are now enrolling men who have sex with men and transgender women who have sex with men into an injectable PrEP study. PrEP (pre-exposure prophylaxis) is an HIV-prevention method that currently involves taking a daily oral medication called Truvada (tenofovir disoproxil fumarate/emtricitabine). The current Phase 2b/3 study, sponsored by the National Institutes of Health, will evaluate the safety and efficacy of a long-acting injectable version of a drug called cabotegravir, compared with oral Truvada.
An injected, long-acting version of PrEP is a much-anticipated development in the field of HIV prevention. The delivery method, which would involve getting an injection every four to eight weeks, may be easier and more convenient for users than taking a daily pill.
The study is open to HIV-negative men who have sex with men and transgender women who are age 18 or over and sexually active. Across all study sites, an estimated 4,500 will be enrolled in the study.
Al Liu, MD, MPH, Clinical Research Director of Bridge HIV, explained that people who are currently taking Truvada for PrEP may participate in the study if they are willing to be randomized to receive either cabotegravir or Truvada during the study (everyone in the study receives an active medication). African American people, transgender women, and young people are encouraged to learn more about the study and participate if interested and eligible.
“Injectable PrEP is a novel and exciting new way to deliver PrEP,” said Liu. “I think this study will be really important in helping us determine the use of cabotegravir for HIV prevention, and could help us expand the available options for PrEP.”
Bridge HIV, in San Francisco, is currently enrolling participants. See powertopreventhiv.org for more information. Other study sites in the U.S. are listed on giveprepashot.org. Sign up to receive the free San Francisco AIDS Foundation publication HIVresource for a quarterly listing of HIV and PrEP studies currently enrolling in the Bay Area, and read the latest issue here.