NIH Begins Clinical Trials for Twice-Yearly HIV Prevention Injection

Key Insights

• Clinical trials are underway to evaluate a long-acting injectable form of HIV pre-exposure prophylaxis (PrEP) using lenacapavir in specific populations.
• The trials focus on cisgender women and people who inject drugs, groups often underrepresented in HIV clinical research, to ensure inclusivity.
• Lenacapavir, already FDA-approved for HIV treatment, is administered via injection every six months and is being tested for its safety and efficacy as PrEP.

U.S. clinical trials have commenced to investigate a novel, long-acting injectable form of HIV pre-exposure prophylaxis (PrEP) administered just twice a year. These mid-stage studies will assess the safety, acceptability, and pharmacokinetics of lenacapavir, an antiretroviral drug, in cisgender women and people who inject drugs, populations historically underrepresented in HIV clinical research.

Trial Design and Objectives

Sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trials Network (HPTN), the trials aim to provide insights into how these priority populations experience lenacapavir-based HIV PrEP. One trial will focus on cisgender women, particularly Black and/or Latina women, while the other will enroll a diverse group of people who inject drugs. Participants will be randomized to receive either injectable lenacapavir or the FDA-approved oral PrEP formulation of tenofovir disoproxil fumarate and emtricitabine. Their health will be closely monitored, and they will provide feedback on their experiences with each PrEP method.

Lenacapavir: A Novel Capsid Inhibitor

Lenacapavir is already FDA-approved for treating HIV infection in heavily treatment-experienced individuals with multidrug resistance, in combination with other antiretroviral therapies. It is the first capsid inhibitor to be approved for HIV treatment and the first long-acting injectable with a six-month dosing interval. The current trials seek to expand its utility to HIV prevention.

Addressing Unmet Needs

In 2021, cisgender women and people who inject drugs accounted for 18% and 7% of new HIV diagnoses in the United States, respectively. Ensuring these and other underrepresented groups, such as transgender people, pregnant people, and U.S. communities of color, are included in clinical research is crucial for developing effective and accessible prevention strategies for all.

Supporting Diverse Populations

These studies are part of a global clinical development program for lenacapavir as HIV PrEP. The NIH supports the implementation of these trials through its clinical trials networks to ensure the meaningful inclusion of diverse and representative populations in clinical research. More information about these trials can be found at ClinicalTrials.gov under study identifiers NCT06101329 and NCT06101342.