Two clinical trials have been initiated to investigate a new long-acting form of HIV pre-exposure prophylaxis (PrEP) specifically targeting cisgender women and individuals who inject drugs. These mid-stage studies are designed to evaluate the safety, acceptability, and pharmacokinetics of lenacapavir, an antiretroviral medication that is administered via injection every six months. The trials are sponsored and funded by Gilead Sciences, Inc., and are being conducted through the HIV Prevention Trials Network (HPTN), with support from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Drug Abuse (NIDA).
Lenacapavir, already FDA-approved for HIV treatment in combination with other antiretroviral therapies, represents a significant advancement as the first capsid inhibitor and the first long-acting injectable requiring administration only once every six months. The trials aim to address the underrepresentation of cisgender women, people who inject drugs, transgender individuals, pregnant people, and U.S. communities of color in HIV clinical studies. These groups accounted for a significant portion of new HIV diagnoses in the United States in 2021.
The studies will be conducted at HPTN sites across the United States, enrolling individuals who could benefit from PrEP. The first trial focuses on cisgender women, with an emphasis on accessibility for Black and Latina women. The second trial will include a diverse group of people who inject drugs. Participants in both studies will be randomly assigned to receive either injectable lenacapavir or an FDA-approved oral PrEP formulation. Throughout the study, participants' health will be closely monitored, and they will provide laboratory samples and qualitative feedback on their experiences with each form of PrEP.
These trials are part of a broader effort to gather important clinical data on lenacapavir as a form of HIV PrEP, with the goal of ensuring the inclusion of diverse and representative populations in clinical research. This approach aims to contribute to scientific progress and ensure that the benefits of research applications are accessible to all. For more information on these trials, visit ClinicalTrials.gov using the identifiers NCT06101329 and NCT06101342.
