Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)

NCT04686279 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: ATN 163
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

HIV/AIDS; HIV Prevention

Keywords

Tenofovir; Tenofovir Douche

Outcome Measures

Primary Outcomes (3)

• Tenofovir Diphosphate (TFV-DP) Concentration

  Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured the study douche administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour post dose), Day 2 (24 hours post dose), or Day 4 (72 hours post dose).

  At 1 hour, 24 hours, or 72 hours after the TFV douche administration

• Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire

  Using a 4-point scale (1=Completely Unacceptable; 2=Somewhat Unacceptable; 3=Somewhat Acceptable; 4=Highly Acceptable), participants were asked to answer the following question about their experience with the product: "If a rectal douche like the one you were administered today at the clinic could protect you against HIV, would you consider using this douche?". The endpoint was operationalized as binary, with scores 1 to 2 grouped as "low acceptability" and scores 3 to 4 as "high acceptability".

  Following administration of study product, up to 1 hour

• Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

  The safety of a single dose of a TFV douche when applied rectally is measured by the number of ≥Grade 2 adverse events (AEs) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, and whether AEs are attributed to the study product.

  Following administration of study product, up to 7 days

Study Arms (1)

TFV Medicated Douche

EXPERIMENTAL

Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 6, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit.

Drug: Tenofovir Douche

Interventions

Tenofovir Douche DRUG

660 mg TFV in 125 mL hypo-osmolar solution

TFV Medicated Douche

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 15-24 at Screening
• Cisgender male who has sex with other men
• Willing and able to communicate in English
• Willing and able to provide informed consent to take part in the study
• Participant demonstrates capacity to comprehend, evaluate, reason, and express a choice about their participation in study
• For youth ages 15-17, have parent or caregiver consent to take part in the study
• Willing and able to provide adequate locator information
• Express initial interest in participating in a douching study
• Understand and agree to local HIV/STI reporting requirements
• HIV-1 uninfected at screening as documented by Combo Ag/Ab HIV- 1/HIV-2 immunoassay
• Willingness and availability to attend all study visits, barring unforeseen circumstances
• Per participant report at screening, consensual RAI in prior 6 months
• Live in or around the Baltimore area.
• Willing to abstain from insertion of anything (drug/medication, digits, penis, object, sex toy, or douche) into the anorectum for 72 hours before and after each study visit and 7 days after the biopsy collection.
• Willing to refrain from aspirin, vitamins and herbal supplements, and NSAID use for one week before and after each study biopsy visit

You may not qualify if:

• Participation in research studies involving drugs, medical devices, genital products, or vaccines within 30 days of the Enrollment Visit.
• History of Hepatitis B infection, as documented by positive HBsAg at screening
• ≥ Grade 2 laboratory abnormality at baseline as defined by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017, and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies)
• Self-report as having used TDF 300 mg/FTC 200 mg (Truvada®) or TAF 25 mg/FTC 200 mg (Descovy®) as HIV PrEP or Truvada as PEP within three weeks of dosing visit.
• Significant colorectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)
• History of an underlying clinically significant cardiac arrhythmia or renal disease (including creatinine clearance \<60 mL/min using Cockcroft-Gault equation)
• Serum phosphate \< 2.3 mg/dL
• History of significant gastrointestinal bleeding
• Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], NSAIDs, or Pradaxa®)
• Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation
• Per participant report, use of any rectally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation
• Known allergic reaction to TFV or other components of the test articles
• Current known HIV-positive partner(s)
• History of recurrent urticaria
• Symptoms suggestive of acute HIV seroconversion at screening and enrollment

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of North Carolina, Chapel Hill: collaborator
• Emory University: collaborator
• Johns Hopkins University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Bauermeister JA, Arrington-Sanders R, Coleman-Lewis J, Bertagnolli LN, Massih S, Marzinke MA, Fuchs EJ, Zheng R, Anderson T, Addison B, Yang YH, Breakey J, Hoffman J, Bakshi RP, Zak AM, Beselman S, Lin W, Agwu AL, Hightow-Weidman L, Hendrix CW. Safety, Pharmacokinetics, and Acceptability of a Tenofovir Rectal Microbicide Douche Among Young Men Who Have Sex With Men: The DREAM ATN Study (ATN 163). J Infect Dis. 2025 Oct 15;232(4):826-834. doi: 10.1093/infdis/jiaf349.

  PMID: 40578814 DERIVED

• Bauermeister JA, Lin W, Webster J, Listerud LL, Burgese T, Agwu A, Lewis JC, Anderson T, Hightow-Weidman L, Hendrix C, Arrington-Sanders R. Assessing the Acceptability of a Tenofovir-Based Rectal Microbicide Douche among Young Men who Have Sex with Men: Results from ATN-DREAM (ATN 163). AIDS Behav. 2025 Oct;29(10):3114-3124. doi: 10.1007/s10461-025-04763-2. Epub 2025 May 29.

  PMID: 40439767 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Craig Hendrix
• Organization: Johns Hopkins University

chendrix@jhmi.edu

410-955-9707

Study Officials

• Craig W Hendrix, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Renata Arrington-Sanders, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Allison L Agwu, MD

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: April 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 30, 2023
• Results First Posted: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)