Evidence map›Paper›PMID 34498980›Full record

Trial reportAIDS research and human retroviruses2022

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

Ross D Cranston, Elizabeth Brown, José Bauermeister, Eileen F Dunne, Craig Hoesley, Ken Ho, Sherri Johnson, Jonathan Lucas, Clara Dominguez-Islas, Holly Gundacker and 14 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in AIDS research and human retroviruses, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 34% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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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

24 authors at 11 institutions in 3 countries.

Ross D CranstonDepartment of Medicine, University of Barcelona, Barcelona, Spain.ORCID 0000-0002-2687-6217
Elizabeth BrownVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
José BauermeisterDepartment of Family and Community Health, University of Pennsylvania, Pennsylvania, Philadelphia, USA.
Eileen F DunneDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Craig HoesleyDepartment of Medical Education, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Ken HoDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Sherri JohnsonFHI 360, Durham, North Carolina, USA.
Jonathan LucasFHI 360, Durham, North Carolina, USA.
Clara Dominguez-IslasVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Holly GundackerStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Melissa PedaStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Cindy E JacobsonMicrobicide Trials Network, Pittsburgh, Pennsylvania, USA.
Lindsay KramzerMicrobicide Trials Network, Pittsburgh, Pennsylvania, USA.
Devika SinghMicrobicide Trials Network, Pittsburgh, Pennsylvania, USA.
Charlene S DezzuttiDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Ratiya Pamela Kunjara Na AyudhyaMicrobicide Trials Network, Pittsburgh, Pennsylvania, USA.
Rhonda M BrandDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Lin WangDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Mark A MarzinkeDivision of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Jeanna PiperDivision of AIDS/NIAID/NIH, Bethesda, Maryland, USA.
Bríd DevlinInternational Partnership for Microbicides, Silver Spring, Maryland, USA.
Jeremy NuttallInternational Partnership for Microbicides, Silver Spring, Maryland, USA.
Ian McGowanDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Craig W HendrixDivision of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
University of Pittsburgh · USFred Hutch Cancer Center · USWorldwide Clinical Trials (United States) · USFamily Health International 360 · USInternational Partnership for Microbicides · USJohns Hopkins University · USCenters for Disease Control and Prevention · USOffice of AIDS Research · USUniversitat de Barcelona · ESUniversity of Alabama at Birmingham · USUniversity of Pennsylvania Health System · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Alan David Levine · 1994 to 2026
$50.0M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS P30 AI036219NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106707PEPFAR
6 · The paper itself

Abstract

Dapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction. MTN-026 explored DPV, formulated as rectal gel, for safety, pharmacokinetics (PK), and acceptability. HIV-uninfected men and women aged 18-45 years were enrolled at United States and Thailand sites and randomized 2:1 to receive DPV 0.05% or placebo gel via rectal applicator. A single-dose phase was followed by seven observed daily doses. Plasma and fluid and tissue from both rectum and cervix were collected at baseline and after the final dose over 72 h for PK,

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdultFemaleGelsHumansMalePyrimidinesUnited StatesAnti-HIV AgentsDapivirineGelsPyrimidinesdapivirineHIVHIV preventionmicrobicidesrectal

Identifiers

PMID34498980
PMCPMC9048178
OpenAlexW3198251066

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.