Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 1 Interventional Accepts healthy volunteers

Tenofovir Rectal Douche to Prevent HIV Transmission

ClinicalTrials.gov ID: NCT04016233

Public ClinicalTrials.gov record NCT04016233. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 7:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I, Open-label Multiple Dose Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Tenofovir Rectal Douche

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. 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 identification

NCT ID
NCT04016233
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Johns Hopkins University
Other
Enrollment
9 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 9, 2020
Primary completion
Apr 26, 2021
Completion
Apr 26, 2021
Last update posted
Jun 8, 2021

2020 – 2021

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Johns Hopkins University Baltimore Maryland 21287
University of Pittsburgh Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04016233, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 8, 2021 · Synced Sep 3, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04016233 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →