NCT04195776 (DREAM-02) is a Phase 1 clinical trial of Tenofovir Douche in HIV/AIDS, sponsored by Johns Hopkins University.

Who is sponsoring NCT04195776?

NCT04195776 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT04195776?

Interventions in NCT04195776: Tenofovir Douche.

What condition does NCT04195776 study?

NCT04195776 studies HIV/AIDS, HIV Prevention.

Is NCT04195776 still recruiting?

NCT04195776 is currently completed. Last updated 17 January 2023.

Last reviewed 2023-01-17 · How we verify

NCT04195776: DREAM-02

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 17 January 2023

What this trial tests

Phase 1 trial testing Tenofovir Douche in HIV/AIDS in 6 participants. Completed in 31 December 2022.

Timeline

1 June 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	6
Start date	1 June 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

Tenofovir Douche — full drug profile →

Conditions studied

HIV/AIDS — all drugs for HIV/AIDS →
HIV Prevention — all drugs for HIV Prevention →

Sponsor

Johns Hopkins University

Who can join

18 and older, male only, with HIV/AIDS or HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anal Sex and Tenofovir Douche Sequence Impacts Colorectal Distribution of HIV Surrogate and Douche: DREAM-02.
Zheng R, Fuchs EJ, Nimmagadda S, Rohan LC, et al · · 2025 · PMID 40447283 · DOI 10.1093/infdis/jiaf286

Verify or expand the search:

Other trials of Tenofovir Douche

Trials testing the same drug.

NCT04686279 — Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM) · Phase 1 · completed

Other recruiting trials for HIV/AIDS

Currently open trials in the same condition.

NCT06741618 — MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM · NA · recruiting
NCT07298785 — Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study · NA · recruiting
NCT07072481 — Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing · NA · recruiting
NCT07064785 — Video-Intervention to Inspire Treatment Adherence for Life for Adolescents · NA · recruiting
NCT07074899 — Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru · NA · active not recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04195776 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 17 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04195776.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing