A National Institutes of Health (NIH)-sponsored clinical trial has commenced to evaluate the safety and acceptability of a new rectal microbicide for HIV prevention. The microbicide, a douche containing the antiretroviral drug tenofovir, is designed for "on-demand" use prior to potential exposure during receptive anal intercourse.
This mid-stage study, known as HPTN 106 (NCT06560684), is being conducted across eight sites in the United States. It addresses the need for diverse HIV prevention strategies, particularly among populations where existing pre-exposure prophylaxis (PrEP) methods may not be sufficient. While oral PrEP and long-acting injections are available, the trial explores rectal microbicides as another on-demand option.
The trial will enroll approximately 150 adults assigned male at birth who routinely use unmedicated rectal douches before receptive anal intercourse. Participants will undergo two two-month periods, one using the tenofovir rectal microbicide douche on-demand and the other using on-demand oral PrEP with tenofovir disoproxil fumarate and emtricitabine. Throughout the study, participants will be closely monitored for safety, acceptability, adherence, and method preference.
"NIH remains committed to developing safe and effective HIV prevention methods that people need, want, and are able to use," stated Sheryl Zwerski, D.N.P., director of the Prevention Sciences Program in NIAID’s Division of AIDS. The trial acknowledges that while HIV incidence is decreasing in the U.S., a significant proportion (67% from 2018-2022) of new diagnoses occur among gay, bisexual, and other men who have sex with men, highlighting the urgency for expanded prevention choices.
The primary goal is to assess the safety profile of the rectal microbicide and gather data on user experience. Secondary endpoints include evaluating adherence rates and user preferences between the rectal microbicide and oral PrEP regimens. The results are expected to inform future HIV prevention strategies and potentially expand the toolkit available to at-risk individuals.
