Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse

Summary

DREAM-02 is a phase 1, open label study to evaluate different sequences of tap water douching and simulated receptive anal intercourse (sRAI) in the presence of a tenofovir douche designed to confer protection from Human Immunodeficiency Virus (HIV) acquisition. DREAM-02 will assess the safety and pharmacokinetics (PK) of different sequences of administration of tap water (H2O) and rectal tenofovir (TFV) douches to more accurately represent the community practice of commonly using cleansing douches prior to RAI, and occasionally after RAI. DREAM-02 results are essential to gain understanding of Tenofovir diphosphate (TFV-DP) concentrations at various anatomic distances in the colon, and how those concentrations may be modified by sRAI, seminal fluid, and sequence of cleansing tap water douches.

Timeline

Start

2021-06-01

Primary completion

2022-12-31

Completion

2022-12-31

Publications

• Zheng R, Fuchs EJ, Nimmagadda S, Rohan LC, Wang L, Bertagnolli LN, Massih S, Caffo BS, Hendrix CW. Anal Sex and Tenofovir Douche Sequence Impacts Colorectal Distribution of HIV Surrogate and Douche: DREAM-02. J Infect Dis. 2025 Sep 15;232(3):588-595. doi: 10.1093/infdis/jiaf286.

Drugs

Indications