Safety, Pharmacokinetics, and Acceptability of a Tenofovir Rectal Microbicide Douche Among Young Men Who Have Sex With Men: The DREAM ATN Study (ATN 163).

ABSTRACT:

Background

Young men who have sex with men (YMSM) are disproportionately affected by human immunodeficiency virus (HIV); however, use of oral preexposure prophylaxis (PrEP) remains suboptimal. This study evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a novel tenofovir (TFV) rectal microbicide douche for HIV prevention.

Methods

Eight HIV-negative YMSM (aged 18-24 years) participated in a single-dose, open-label trial. Each received 660 mg of TFV in a 125-mL rectal douche. Safety was assessed via clinical monitoring and adverse event (AE) reporting. PK analysis measured TFV and TFV-diphosphate (TFV-DP) concentrations in blood and rectal tissue. PD was evaluated using ex vivo HIV-1 challenge assays in rectal biopsies.

Results

No

SUBMITTER: Bauermeister JA 

PROVIDER: S-EPMC12645277 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature