Evidence map›Paper›PMID 36255254›Full record

Trial reportAntimicrobial agents and chemotherapy2022

MTN-033: a Phase 1 Study Comparing Applicator versus "as Lubricant" Delivery of Rectal Dapivirine Gel.

Ken Ho, Clara Dominguez-Islas, Daniel Szydlo, Stacey Edick, Nicole Macagna, Sharon A Riddler, Rhonda M Brand, Cindy E Jacobson, Lindsay Kramzer, Ratiya P Kunjara Na Ayudhya and 6 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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

16 authors at 9 institutions in 1 country.

Ken HoUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-7973-1268
Clara Dominguez-IslasFred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, Washington, USA.
Daniel SzydloFred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, Washington, USA.
Stacey EdickUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Nicole MacagnaFHI 360, Durham, North Carolina, USA.
Sharon A RiddlerUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Rhonda M BrandUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Cindy E JacobsonMagee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Lindsay KramzerMagee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
Ratiya P Kunjara Na AyudhyaUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Jeanna PiperDivision of AIDS, NIAID, NIH, Bethesda, Maryland, USA.
Mark A MarzinkeJohns Hopkins University School of Medicinegrid.471401.7, Baltimore, Maryland, USA.ORCID 0000-0003-1670-8786
Jose BauermeisterUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA.
Jeremy NuttallInternational Partnership for Microbicidesgrid.429161.9, Silver Spring, Maryland, USA.
Sharon L HillierUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Craig W HendrixJohns Hopkins University School of Medicinegrid.471401.7, Baltimore, Maryland, USA.
University of Pittsburgh · USFred Hutch Cancer Center · USJohns Hopkins University · USMagee-Womens Research Institute · USFamily Health International 360 · USInternational Partnership for Microbicides · USOffice of AIDS Research · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · 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
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 UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

Data to inform behaviorally congruent delivery of rectal microbicides as lubricants are scant. Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor which has been demonstrated to be well-tolerated and efficacious in multiple clinical trials when used in a vaginal ring formulation. DPV gel administered rectally with an applicator was found to be well-tolerated in a phase 1 clinical trial. MTN-033, a single site, open label, sequence randomized, crossover study, enrolled HIV-negative men to receive 0.05% DPV gel intrarectally using an applicator (2.5 g) and self-administered on an artificial phallus as lubricant (up to 10 g). The study evaluated the pharmacokinetics (in plasma, rectal fluid, and mucosal rectal tissue), safety, acceptability, and pharmacodynamics of DPV gel when applied rectally. Statistical comparisons between methods of application were performed using mixed effects models or Wilcoxon's signed rank tests. Sixteen participants used DPV gel by applicator and 15/16 participants used gel as lubricant (mean, 1.8 g; SD, 0.8). DPV plasma AUC

Indexed as

Anti-HIV AgentsHIV InfectionsCross-Over StudiesFemaleGelsHumansLubricantsMalePyrimidinesReverse Transcriptase InhibitorsAnti-HIV AgentsDapivirineGelsLubricantsPyrimidinesReverse Transcriptase Inhibitorsbehavioral congruenceHIV preventionlubricantmicrobicidemicrobicideson demandpharmacokineticrectal

Identifiers

PMID36255254
PMCPMC9664840
OpenAlexW4306730520

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.