Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
CONRAD National Institute of Allergy and Infectious Diseases (NIAID)