Two clinical trials have been launched to investigate a new long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies, sponsored and funded by Gilead Sciences, Inc. and implemented through the HIV Prevention Trails Network (HPTN), will evaluate the safety, acceptability, and pharmacokinetics of lenacapavir, an antiretroviral drug administered by injection every six months. The HPTN is supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, with scientific collaboration and co-funding from the National Institute on Drug Abuse (NIDA) and other NIH institutes.
Lenacapavir, already approved by the Food and Drug Administration for HIV treatment in combination with other antiretroviral therapy for heavily treatment-experienced individuals, is the first of a class of drugs called capsid inhibitors to be FDA-approved for treating HIV infection. It is also the first long-acting injectable to be offered with administration just once every six months. Cisgender women and people who inject drugs accounted for 18% and 7% of new HIV diagnoses in the United States in 2021, respectively, and have been underrepresented in HIV clinical studies, along with transgender people, pregnant people, and U.S. communities of color.
Complementing Ongoing Efficacy Studies
The two trials complement ongoing large efficacy studies and aim to provide insights on how cisgender women and people who inject drugs experience lenacapavir-based HIV PrEP. 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 focus on cisgender women, with an emphasis 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.
Study Design and Monitoring
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 closely monitored throughout the study, and they will provide laboratory samples and qualitative feedback on their experience taking each form of PrEP.
The studies will contribute important clinical data to a global manufacturer-led clinical development program for lenacapavir as HIV PrEP. NIH is supporting the implementation of these two studies through its clinical trials networks to help ensure the meaningful inclusion of diverse and representative populations in clinical research, allowing everyone to contribute to scientific progress and benefit from its applications.
For more information about these trials, please visit ClinicalTrials.gov study identifiers NCT06101329 and NCT06101342.
The development of long-acting HIV prevention options, such as lenacapavir, has the potential to expand the range of choices available to individuals at risk of HIV infection, particularly those from underrepresented communities. By focusing on cisgender women and people who inject drugs, these clinical trials seek to address the specific needs and experiences of these populations, ultimately contributing to more equitable access to effective HIV prevention strategies.
