Evidence map›Paper›PMID 38019657›Full record

Trial reportThe Journal of infectious diseases2024

Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics (DREAM 01).

Ethel D Weld, Ian McGowan, Peter Anton, Edward J Fuchs, Ken Ho, Alex Carballo-Dieguez, Lisa C Rohan, Rebecca Giguere, Rhonda Brand, Stacey Edick and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02750540 (DREAM-01), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
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.

NCT02750540 phase1completednot on this map

DREAM-01: Optimization of a Tenofovir Enema for HIV Prevention

TypeinterventionalSponsorJohns Hopkins UniversityRan2016 to 2019Enrolled21ConditionsHIV PreventionArmsTenofovir enema, Saline enema
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
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

25 authors at 6 institutions in 1 country.

Ethel D WeldDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-9519-3348
Ian McGowanDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Peter AntonDivision of Gastroenterology, Department of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Edward J FuchsDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ken HoDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Alex Carballo-DieguezHIV Center for Clinical and Behavioral Studies, Columbia University and NewYork State Psychiatric Institute, New York, New York, USA.
Lisa C RohanMagee Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Rebecca GiguereHIV Center for Clinical and Behavioral Studies, Columbia University and NewYork State Psychiatric Institute, New York, New York, USA.
Rhonda BrandDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Stacey EdickDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Rahul P BakshiDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Teresa ParsonsDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Madhuri ManoharDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Aaron SeigelMagee Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Jared EngstromDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Julie ElliottDivision of Gastroenterology, Department of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Cindy JacobsonMagee Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Christina BagiaMagee Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Lin WangMagee Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Amer Al-KhoujaDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Douglas J HartmanDepartment of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Namandje N BumpusDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Hans M L SpiegelKelly Government Solutions, Contractor to Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.
Mark A MarzinkeDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-5696-8665
Johns Hopkins University · USUniversity of Pittsburgh · USMagee-Womens Research Institute · USNew York Psychoanalytic Society and Institute · USUniversity of California, Los Angeles · USNational Institutes of Health · US

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Tissue pharmacology imaging and modelingU19AI113127 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MCGOWAN, IAN MICHAEL · 2014 to 2018
$20.7M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIAID NIH HHS P30 AI094189NIAID NIH HHS U19 AI113127NIGMS NIH HHS T32 GM066691NIH HHS
6 · The paper itself

Abstract

backgroundDespite highly effective HIV preexposure prophylaxis (PrEP) options, no options provide on-demand, nonsystemic, behaviorally congruent PrEP that many desire. A tenofovir-medicated rectal douche before receptive anal intercourse may provide this option.

methodsThree tenofovir rectal douches-220 mg iso-osmolar product A, 660 mg iso-osmolar product B, and 660 mg hypo-osmolar product C-were studied in 21 HIV-negative men who have sex with men. We sampled blood and colorectal tissue to assess safety, acceptability, pharmacokinetics, and pharmacodynamics.

resultsThe douches had high acceptability without toxicity. Median plasma tenofovir peak concentrations for all products were several-fold below trough concentrations associated with oral tenofovir disoproxil fumarate (TDF). Median colon tissue mucosal mononuclear cell (MMC) tenofovir-diphosphate concentrations exceeded target concentrations from 1 hour through 3 to 7 days after dosing. For 6-7 days after a single product C dose, MMC tenofovir-diphosphate exceeded concentrations expected with steady-state oral TDF 300 mg on-demand 2-1-1 dosing. Compared to predrug baseline, HIV replication after ex vivo colon tissue HIV challenge demonstrated a concentration-response relationship with 1.9 log10 maximal effect.

conclusionsAll 3 tenofovir douches achieved tissue tenofovir-diphosphate concentrations and colorectal antiviral effect exceeding oral TDF and with lower systemic tenofovir. Tenofovir douches may provide a single-dose, on-demand, behaviorally congruent PrEP option, and warrant continued development. Clinical Trials Registration . NCT02750540.

Indexed as

AdenineAnti-HIV AgentsColorectal NeoplasmsHIV InfectionsOrganophosphatesPre-Exposure ProphylaxisSexual and Gender MinoritiesDiphosphatesEmtricitabineHomosexuality, MaleHumansMaleTenofovirAdenineAnti-HIV AgentsDiphosphatesEmtricitabineOrganophosphatesTenofovirtenofovir diphosphateHIVmicrobicidepharmacodynamicspharmacokineticsphase 1preexposure prophylaxis

Identifiers

PMID38019657
PMCPMC11011183
OpenAlexW4389131680

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.