Evidence map›Paper›PMID 25005891›Full record

ArticleJournal of pharmaceutical and biomedical analysis2014

Dual quantification of dapivirine and maraviroc in cervicovaginal secretions from ophthalmic tear strips and polyester-based swabs via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis.

Teresa L Parsons, Joshua F Emory, Lauren A Seserko, Wutyi S Aung, Mark A Marzinke

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pharmaceutical and biomedical analysis, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.3field-weighted citation impact, top 22% 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

18 citing papers in PubMed, 24 citations in OpenAlex.

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  7. Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
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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

5 authors at 1 institution in 1 country.

Teresa L ParsonsDepartment of Medicine, Johns Hopkins University, 600 North Wolfe Street, Osler 500, Baltimore, MD 21287, USA.
Joshua F EmoryDepartment of Medicine, Johns Hopkins University, 600 North Wolfe Street, Osler 500, Baltimore, MD 21287, USA.
Lauren A SeserkoDepartment of Medicine, Johns Hopkins University, 600 North Wolfe Street, Osler 500, Baltimore, MD 21287, USA.
Wutyi S AungDepartment of Medicine, Johns Hopkins University, 600 North Wolfe Street, Osler 500, Baltimore, MD 21287, USA.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, 600 North Wolfe Street, Osler 500, Baltimore, MD 21287, USA; Department of Pathology, Johns Hopkins University, 1800 Orleans Street, Sheikh Zayed Tower, B1020-G, Baltimore, MD 21287, USA. Electronic address: mmarzin1@jhmi.edu.
Johns Hopkins University · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
Pharmaceutical and Regulatory CoreU19AI082639 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI FRIEND, DAVID R · 2010 to 2014
$13.0M
NIAID NIH HHS U19 AI082639NIAID NIH HHS U19-AI082639NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1-AI068613NIAID NIH HHS UM1 AI068633
6 · The paper itself

Abstract

backgroundTopical microbicidal agents are being actively pursued as a modality to prevent HIV viral transmission during sexual intercourse. Quantification of antiretroviral agents in specimen sources where antiviral activity is elicited is critical, and drug measurements in cervicovaginal fluid can provide key information on local drug concentrations. Two antiretroviral drugs, dapivirine and maraviroc, have gained interest as vaginal microbicidal agents, and rugged methods are required for their quantification in cervicovaginal secretions.

methodsCervicovaginal fluid spiked with dapivirine and maraviroc were applied to ophthalmic tear strips or polyester-based swabs to mimic collection procedures used in clinical studies. Following sample extraction and the addition of isotopically labeled internal standards, samples were subjected to liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis using a Waters BEH C8, 50mm×2.1mm, 1.7μm particle size column, on an API 4000 mass analyzer operated in selective reaction monitoring mode. The method was validated according to FDA Bioanalytical Method Validation guidelines.

resultsDue to the disparate saturation capacity of the tested collection devices, the analytical measuring ranges for dapivirine and maravirocin cervicovaginal fluid on the ophthalmic tear strip were 0.05-25ng/tear strip, and 0.025-25ng/tear strip, respectively. As for the polyester-based swab, the analytical measuring ranges were 0.25-125ng/swab for dapivirine and 0.125-125ng/swab for maraviroc. Dilutional studies were performed for both analytes to extended ranges of 25,000ng/tear strip and 11,250ng/swab. Standard curves were generated via weighted (1/x(2)) linear or quadratic regression of calibrators. Precision, accuracy, stability and matrix effects studies were all performed and deemed acceptable according to the recommendations of the FDA Bioanalytical Method Validation guidelines.

conclusionsA rugged LC-MS/MS method for the dual quantification of dapivirine and maraviroc in cervicovaginal fluid using two unique collection devices has been developed and validated. The described method meets the criteria to support large research trials.

Indexed as

Antiviral AgentsCalibrationCervix UteriChromatography, LiquidCyclohexanesFemaleHumansMaravirocPolyestersPyrimidinesReagent StripsTandem Mass SpectrometryTriazolesVaginaAntiviral AgentsCyclohexanesDapivirineMaravirocPolyestersPyrimidinesReagent StripsTriazolesAntiretroviralCervicovaginal fluidDapivirineMaravirocValidation

Identifiers

PMID25005891
PMCPMC4143664
OpenAlexW2078826760

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.