Evidence map›Paper›PMID 33371779›Full record

Trial reportAIDS research and human retroviruses2021

Examining the Safety, Pharmacokinetics, and Pharmacodynamics of a Rectally Administered IQP-0528 Gel for HIV Pre-Exposure Prophylaxis: A First-In-Human Study.

Amer Al-Khouja, Eugenie Shieh, Edward J Fuchs, Mark A Marzinke, Rahul P Bakshi, Pamela Hummert, Anthony S Ham, Karen W Buckheit, Jennifer Breakey, Ethel D Weld and 4 more

Abstract readClinical Trial
In one paragraph

Trial report in AIDS research and human retroviruses, 2021. 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
–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.

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.

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

14 authors.

Amer Al-KhoujaDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Eugenie ShiehDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Edward J FuchsDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mark A MarzinkeDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Rahul P BakshiDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Pamela HummertDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Anthony S HamImQuest BioSciences, Frederick, Maryland, USA.
Karen W BuckheitImQuest BioSciences, Frederick, Maryland, USA.
Jennifer BreakeyDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ethel D WeldDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Huan ChenDepartment of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Brian S CaffoDepartment of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Robert W BuckheitImQuest BioSciences, Frederick, Maryland, USA.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIAID NIH HHS P30 AI094189NIGMS NIH HHS T32 GM066691
6 · The paper itself

Abstract

A lubricating microbicide gel designed for rectal and vaginal use would provide a behaviorally congruent strategy to enhance pre-exposure prophylaxis adherence and reduce HIV infection risk. In this study, we report the first-in-human evaluation of such a gel containing 1% IQP-0528, an investigational antiretroviral. Seven HIV-1-negative participants received one 10 mL rectal dose of radiolabeled 1% IQP-0528 gel. We assessed safety; IQP-0528 pharmacokinetics in plasma, and rectal and vaginal tissue;

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsPre-Exposure ProphylaxisFemaleHumansPyrimidinonesAnti-HIV AgentsIQP-0528Pyrimidinonesclinical trialsHIVpharmacokineticspharmacologypre-exposure prophylaxisrectal microbicide

Identifiers

PMID33371779
PMCPMC8213010

What OpenQuestion holds

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Registered trials

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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.