Clinical trial of twice-yearly HIV shot begins in US

Media Advisory

Tuesday, June 4, 2024

The study will focus on priority populations that are underrepresented in HIV clinical research.

what

Two clinical trials have begun testing a new, long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will evaluate the safety, acceptability, and pharmacokinetics (how the drug moves in the body) of the antiretroviral drug lenacapavir, given as an injection every six months. The studies are sponsored and funded by Gilead Sciences and conducted through the HIV Prevention Trails Network (HPTN). HPTN is supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), with scientific collaboration on this and other studies from the National Institute on Drug Abuse (NIDA), as well as co-funding from other institutes at NIDA and NIH.

Lenacapavir, in combination with other antiretroviral therapies, is already approved by the Food and Drug Administration for the treatment of HIV in many treatment-experienced individuals whose HIV infection cannot be successfully treated with other available therapies due to resistance, intolerance, or safety concerns to other drugs or the emergence of multidrug resistance. Lenacapavir is the first of a class of drugs called capsid inhibitors to be approved by the FDA for the treatment of HIV infection. It is the first long-acting injectable available in a single dose every six months. Cisgender women (people who identify as women and were assigned female gender at birth) and people who inject drugs accounted for 18% and 7%, respectively, of newly diagnosed HIV cases in the United States in 2021. Both population groups have been underrepresented in HIV clinical studies, as have transgender people, pregnant people, and communities of color in the United States. Both trials complement a large ongoing efficacy study and are intended to provide insight into how these two priority populations experience lenacapavir-based HIV PrEP.

The studies will be conducted at HPTN facilities in the United States and will enroll people who may benefit from taking PrEP. The first trial will focus on enrolling cisgender women, with an emphasis on making it easier for women who identify as Black and/or Latino to enroll. The second trial will enroll a diverse group who inject the drug. In both trials, participants will be randomly assigned to receive either injectable lenacapavir or an FDA-approved formulation of PrEP consisting of oral tenofovir disoproxil fumarate and emtricitabine. Participants' health will be closely monitored throughout the study. Participants will provide laboratory samples and provide qualitative feedback about their experience taking each form of PrEP.

These studies will add important clinical data to the manufacturer-led global clinical development program for lenacapavir as HIV PrEP. NIH is supporting the implementation of these two studies through its Clinical Trials Network to ensure that diverse and representative populations are meaningfully included in clinical research, so that everyone can contribute to scientific advances and benefit from their applications.