Evidence map›Paper›PMID 40578814›Full record

Trial reportThe Journal of infectious diseases2025

Safety, Pharmacokinetics, and Acceptability of a Tenofovir Rectal Microbicide Douche Among Young Men Who Have Sex With Men: The DREAM ATN Study (ATN 163).

Jose A Bauermeister, Renata Arrington-Sanders, Jessica Coleman-Lewis, Lynn N Bertagnolli, Sandra Massih, Mark A Marzinke, Edward J Fuchs, Ruohui Zheng, Thuy Anderson, Bonnie Addison and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04686279 (Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04686279 phase1completednot on this map

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

TypeinterventionalSponsorUniversity of PennsylvaniaRan2021 to 2022Enrolled8ConditionsHIV/AIDS, HIV PreventionArmsTenofovir Douche
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Jose A BauermeisterSchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-9276-2306
Renata Arrington-SandersSchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Jessica Coleman-LewisSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Lynn N BertagnolliSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Sandra MassihSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0003-3544-1319
Mark A MarzinkeSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0003-1670-8786
Edward J FuchsSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Ruohui ZhengSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0002-5797-8128
Thuy AndersonSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Bonnie AddisonSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Yeng H YangSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Jennifer BreakeySchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Jennifer HoffmanSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Rahul P BakshiSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0003-1478-1031
Alexander M ZakSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Sasha BeselmanSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Willey LinSchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID 0000-0001-6174-4060
Allison L AgwuSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Lisa Hightow-WeidmanSchool of Nursing, Florida State University, Tallahassee, Florida, USA.ORCID 0000-0002-2421-923X
Craig W HendrixSchool of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0002-5696-8665

Funding

Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Carlos del Rio · 2002 to 2026
$74.0M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
The UNC/Emory Center for Innovative Technology (iTech) across the prevention and care continuumU19HD089881 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HIGHTOW-WEIDMAN, LISA B, SULLIVAN, PATRICK SEAN · 2016 to 2022
$35.8M
NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050409NIAID NIH HHS P30 AI094189NICHD NIH HHS U19 HD089881
6 · The paper itself

Abstract

backgroundYoung men who have sex with men (YMSM) are disproportionately affected by human immunodeficiency virus (HIV); however, use of oral preexposure prophylaxis (PrEP) remains suboptimal. This study evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a novel tenofovir (TFV) rectal microbicide douche for HIV prevention.

methodsEight HIV-negative YMSM (aged 18-24 years) participated in a single-dose, open-label trial. Each received 660 mg of TFV in a 125-mL rectal douche. Safety was assessed via clinical monitoring and adverse event (AE) reporting. PK analysis measured TFV and TFV-diphosphate (TFV-DP) concentrations in blood and rectal tissue. PD was evaluated using ex vivo HIV-1 challenge assays in rectal biopsies.

resultsNo serious AEs occurred. Five mild to moderate AEs (eg, nausea, hyperglycemia) were reported, none related to the product. Median peak plasma TFV concentration (14.5 ng/mL) remained below levels seen with oral TDF. Median peak (24-hour) rectal tissue cell TFV-DP concentrations were 8319 fmol/106 cells with a corresponding 0.9 log10 HIV-1 p24 antigen reduction observed in ex vivo challenge assays. Rectal tissue TFV-DP concentrations exceeded those associated with on-demand oral 2-1-1 dosing from 1 to 72 hours and suppressed HIV-1 p24 antigen production in colonic explants. Acceptability was high: 87.5% reported satisfaction, and 75% would consider future use.

conclusionsThe TFV rectal douche was safe, well tolerated, and acceptable to YMSM. Its favorable PK and PD profiles support further investigation as a behaviorally congruent, on-demand PrEP strategy. Additional studies are needed to assess long-term safety and efficacy in larger, more diverse populations. CLINICAL TRIALS REGISTRATION: NCT04686279.

Indexed as

Anti-HIV AgentsHIV InfectionsTenofovirAdenineAdministration, RectalAdolescentHIV-1Homosexuality, MaleHumansMalePre-Exposure ProphylaxisRectumSexual and Gender MinoritiesYoung AdultAdenineAnti-HIV AgentsTenofoviradolescentsdouchingHIV preventionPrEPsexual minorities

Identifiers

PMID40578814
PMCPMC12645277

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.