CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Tenofovir Douchedrug
Likely dose
Tenofovir Douche 660 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04686279
NCT04686279Phase 1Completed
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Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM)

University of Pennsylvania·interventional·Posted Dec 28, 2020·Updated Oct 30, 2023

In Brief

A Phase 1 clinical trial evaluating Tenofovir Douche for HIV/AIDS and HIV Prevention. Completed, enrolled 8 participants across 3 sites.

Detailed Summary

ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS, HIV Prevention
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill, Emory University, Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 28, 2020
Enrollment StartApr 1, 2021
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.5 years ago

Interventions

Tenofovir Douchedrug

660 mg TFV in 125 mL hypo-osmolar solution