HIV/AIDSPhase 1NCT04686279
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
A Phase 1 study testing Tenofovir Douche in people with HIV/AIDS and HIV Prevention, run by University of Pennsylvania at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Prevention
- What is being tested?
- Tenofovir Douche
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2021to 30 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
- Agrees not to participate in other research studies involving drugs and/ or medical devices for the study's duration
Who cannot join
- 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)
- At screening or within the past 2 months: participant- reported symptoms and/or clinical or laboratory diagnosis of active rectal infection requiring treatment per current CDC guidelines. Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. Note that HSV seropositivity with no active genital lesions is not an exclusion criterion. (Note: if an STI apart from HIV is detected, the participant will be referred for treatment and can be retested in 30 days and rescreened once).
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- 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
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.
- Presence of substance use (e.g., Cocaine, Marijuana, Opiates, Amphetamines, Methamphetamine, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants, Oxycodone, and Propoxyphene) in one-step urine drug test.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM)
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
Read the detailed description
On demand and behaviorally-congruent forms of HIV pre-exposure prophylaxis (PrEP) have long been demanded by communities at great risk of HIV, especially men who have sex with men (MSM). The DREAM Program is developing a tenofovir (TFV) douche for on demand PrEP use prior to receptive anal intercourse (RAI), given that the vast majority of MSM very commonly douche prior to RAI (behaviorally-congruent). This ATN protocol seeks to ensure the inclusion of adolescent and young adults' (age 15-24 years) perspectives as next generation biomedical prevention, specifically a rectal douche, is being developed for efficacy.
ATN DREAM is an early phase 1, open label study to compare the safety, PK, PD, and acceptability of a TFV-medicated douche. Each participant will undergo a Screening Visit to evaluate eligibility. Baseline Visit will assess pre-dose safety, PK, PD, and behavioral points of reference. Safety, PK, PD, and behavioral readouts are assessed at specified times after the single dose. The TFV douche to be used consists of TFV 660 mg in 125 mL half-normal saline (TFV 5.28 mg/mL). Study objectives including safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a single TFV douche, are essential to inform the design of an extended safety study of a TFV douche in outpatient pre-RAI contexts. The necessity of extending the testing of new HIV prevention modalities to this proposed adolescent population is motivated by anticipated behavioral differences, not biological ones.
Participant accrual will take approximately 9 months and each participant will be on study for approximately 3 months. Total study duration is about 1 year.
- Conditions
- HIV/AIDS, HIV Prevention
- Being tested
- Tenofovir Douche
- Keywords
- Tenofovir, Tenofovir Douche
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DoucheDrug
660 mg TFV in 125 mL hypo-osmolar solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tenofovir Douche |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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".
Measured: 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.
Measured: Following administration of study product, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Emory University, Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Craig W Hendrix, MD, Principal investigator, Johns Hopkins UniversityRenata Arrington-Sanders, MD, Study director, Johns Hopkins UniversityAllison L Agwu, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686279
- Sponsor's protocol ID
- ATN 163
- Status last verified
- Oct 2023
- First submitted
- 22 Dec 2020
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40578814Bauermeister 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.
PubMed 40439767
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM)
- ClinicalTrials.gov ID
- NCT04686279
- Acronym / sponsor ID
- ATN 163
- Conditions
- HIV/AIDS, HIV Prevention
- Keywords
- Tenofovir, Tenofovir Douche
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Emory University, Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 30 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
On demand and behaviorally-congruent forms of HIV pre-exposure prophylaxis (PrEP) have long been demanded by communities at great risk of HIV, especially men who have sex with men (MSM). The DREAM Program is developing a tenofovir (TFV) douche for on demand PrEP use prior to receptive anal intercourse (RAI), given that the vast majority of MSM very commonly douche prior to RAI (behaviorally-congruent). This ATN protocol seeks to ensure the inclusion of adolescent and young adults' (age 15-24 years) perspectives as next generation biomedical prevention, specifically a rectal douche, is being developed for efficacy.
ATN DREAM is an early phase 1, open label study to compare the safety, PK, PD, and acceptability of a TFV-medicated douche. Each participant will undergo a Screening Visit to evaluate eligibility. Baseline Visit will assess pre-dose safety, PK, PD, and behavioral points of reference. Safety, PK, PD, and behavioral readouts are assessed at specified times after the single dose. The TFV douche to be used consists of TFV 660 mg in 125 mL half-normal saline (TFV 5.28 mg/mL). Study objectives including safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a single TFV douche, are essential to inform the design of an extended safety study of a TFV douche in outpatient pre-RAI contexts. The necessity of extending the testing of new HIV prevention modalities to this proposed adolescent population is motivated by anticipated behavioral differences, not biological ones.
Participant accrual will take approximately 9 months and each participant will be on study for approximately 3 months. Total study duration is about 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TFV Medicated Douche | Experimental | Drug: Tenofovir DoucheOnce 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Douche660 mg TFV in 125 mL hypo-osmolar solution | Drug | TFV Medicated Douche |
Primary outcome
Tenofovir Diphosphate (TFV-DP) Concentration
Time frame: At 1 hour, 24 hours, or 72 hours after the TFV douche administration
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).
Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire
Time frame: Following administration of study product, up to 1 hour
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".
Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
Time frame: Following administration of study product, up to 7 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40578814Bauermeister 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.
- Derived from this study: PubMed 40439767Bauermeister 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig W Hendrix, MD principal investigator
Johns Hopkins University
Renata Arrington-Sanders, MD study director
Johns Hopkins University
Allison L Agwu, MD study director
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir Douche in people with HIV/AIDS and HIV Prevention, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenofovir Diphosphate (TFV-DP) Concentration (time frame: At 1 hour, 24 hours, or 72 hours after the TFV douche administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.