Evidence map›Paper›PMID 34541872›Full record

Trial reportAIDS research and human retroviruses2022

An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate.

Ian M McGowan, Ratiya Pamela Kunjara Na Ayudhya, Rhonda M Brand, Mark A Marzinke, Craig W Hendrix, Sherri Johnson, Jeanna Piper, Timothy H Holtz, Marcel E Curlin, Anupong Chitwarakorn and 5 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.7field-weighted citation impact, top 26% 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

10 citing papers in PubMed, 12 citations in OpenAlex.

  1. 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

15 authors at 10 institutions in 4 countries.

Ian M McGowanDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-6470-8476
Ratiya Pamela Kunjara Na AyudhyaUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Rhonda M BrandDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Mark A MarzinkeDepartment of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.
Craig W HendrixDepartment of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.
Sherri JohnsonFHI 360, Durham, North Carolina, USA.
Jeanna PiperNational Institute of Allergy and Infectious Disease, Bethesda, Maryland, USA.
Timothy H HoltzDivision of HIV/AIDS Prevention, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Marcel E CurlinDivision of HIV/AIDS Prevention, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Anupong ChitwarakornThailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.
Boonyos RaengsakulrachThailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.
Gustavo DoncelCONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.
Jill L SchwartzCONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.
James F RooneyGilead Sciences, Foster City, California, USA.
Ross D CranstonDepartment of Medicine, University of Barcelona, Barcelona, Spain.ORCID 0000-0002-2687-6217
Centers for Disease Control and Prevention · USEastern Virginia Medical School · USJohns Hopkins University · USMinistry of Public Health · THUniversity of Pittsburgh · USFamily Health International 360 · USGilead Sciences (United States) · USNational Institute of Allergy and Infectious Diseases · USUniversitat de Barcelona · ESUniversity 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
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Immaculate Lillian Nankya · 1994 to 2026
$50.0M
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 AI106707
6 · The paper itself

Abstract

The Microbicide Trials Network-017 study was undertaken to characterize the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic profile of the reduced-glycerin (RG) 1% tenofovir (RG-TFV) gel compared to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). The study was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study. In each 8-week study period, HIV-1-uninfected participants were randomized to RG-TFV rectal gel daily or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. A mucosal substudy was conducted at sites in the United States and Thailand. Samples were collected to evaluate PK and

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsPre-Exposure ProphylaxisSexual and Gender MinoritiesCross-Over StudiesEmtricitabineFemaleHomosexuality, MaleHumansMaleReverse Transcriptase InhibitorsTenofovirAnti-HIV AgentsEmtricitabineReverse Transcriptase InhibitorsTenofoviremtricitabineHIVmicrobicidepreventionrectaltenofovir

Identifiers

PMID34541872
PMCPMC9048169
OpenAlexW3201184588

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.