Evidence map›Paper›PMID 26093158›Full record

ArticleAntiviral research2015

The rational design and development of a dual chamber vaginal/rectal microbicide gel formulation for HIV prevention.

Anthony S Ham, Sean T Nugent, Jennifer J Peters, David F Katz, Cory M Shelter, Charlene S Dezzutti, Ashlee D Boczar, Karen W Buckheit, Robert W Buckheit

Open access · greenAbstract read
In one paragraph

Article in Antiviral research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.1field-weighted citation impact, top 14% 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

17 citing papers in PubMed, 25 citations in OpenAlex.

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  11. On-demand microbicide products: design matters.Drug delivery and translational research · 2017
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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

9 authors at 4 institutions in 1 country.

Anthony S HamImQuest BioSciences Inc., Frederick, MD 21704, USA. Electronic address: aham@imquestbio.com.
Sean T NugentImQuest BioSciences Inc., Frederick, MD 21704, USA.
Jennifer J PetersDuke University, Durham, NC 27708, USA.
David F KatzDuke University, Durham, NC 27708, USA.
Cory M ShelterMagee-Womens Research Institute, Pittsburgh, PA 15213, USA.
Charlene S DezzuttiUniversity of Pittsburgh, Pittsburgh, PA 15213, USA; Magee-Womens Research Institute, Pittsburgh, PA 15213, USA.
Ashlee D BoczarImQuest BioSciences Inc., Frederick, MD 21704, USA.
Karen W BuckheitImQuest BioSciences Inc., Frederick, MD 21704, USA.
Robert W BuckheitImQuest BioSciences Inc., Frederick, MD 21704, USA.
ImQuest BioSciences (United States) · USDuke University · USMagee-Womens Research Institute · USUniversity of Pittsburgh · US

Funding

Scientific CoreU19AI101961 · NIAID · IMQUEST BIOSCIENCES · PI KATZ, DAVID FRANK · 2012 to 2016
$14.3M
NIAID NIH HHS U19 AI101961NIAID NIH HHS U19AI101961
6 · The paper itself

Abstract

The DuoGel™ was developed for safe and effective dual chamber administration of antiretroviral drugs to reduce the high incidence of HIV transmission during receptive vaginal and anal intercourse. The DuoGel™s containing IQP-0528, a non-nucleoside reverse transcriptase inhibitor (NNRTI), were formulated from GRAS excipients approved for vaginal and rectal administration. The DuoGel™s were evaluated based upon quantitative physicochemical and biological evaluations defined by a Target Product Profile (TPP) acceptable for vaginal and rectal application. From the two primary TPP characteristics defined to accommodate safe rectal administration three DuoGel™ formulations (IQB3000, IQB3001, and IQB3002) were developed at pH 6.00 and osmolality ⩽400mmol/kg. The DuoGel™s displayed no in vitro cellular or bacterial toxicity and no loss in viability in ectocervical and colorectal tissue. IQB3000 was removed from consideration due to reduced NNRTI delivery (∼65% reduction) and IQB3001 was removed due to increase spread resulting in leakage. IQB3002 containing IQP-0528 was defined as our lead DuoGel™ formulation, possessing potent activity against HIV-1 (EC50=10nM). Over 12month stability evaluations, IQB3002 maintained formulation stability. This study has identified a lead DuoGel™ formulation that will safely deliver IQP-0528 to prevent sexual HIV-1 transmission in the vagina and rectum.

Indexed as

Administration, IntravaginalAdministration, RectalAnti-Infective AgentsChemistry, PharmaceuticalChemopreventionDrug StabilityExcipientsFemaleGelsHIV-1HIV InfectionsHumansPyrimidinonesAnti-Infective AgentsExcipientsGelsIQP-0528PyrimidinonesFormulationHIV preventionMicrobicidesPyrimidinedioneRectal gelVaginal gel

Identifiers

PMID26093158
PMCPMC4492852
OpenAlexW589407763

What OpenQuestion holds

Textmetadata
LicenceTDM
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.