U.S. clinical trials begin for twice-yearly HIV prevention injection

June 5, 2024
Studies will focus on priority populations underrepresented in HIV clinical research.

Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs.

The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.

The studies will take place at HPTN sites in the United States and enroll people who might benefit from taking PrEP. The first trial will enroll cisgender women, with a focus on making enrollment accessible to women who self-identify as Black and/or Latina. The second trial will enroll a diverse group of people who inject drugs. In both studies, participants will be randomly assigned to receive either injectable lenacapavir or an FDA-approved PrEP formulation consisting of oral tenofovir disoproxil fumarate and emtricitabine. Participants’ health will be monitored closely throughout the study. Participants will provide laboratory samples and give qualitative feedback on their experience taking each form of PrEP.

NIH release