Evidence map›Paper›PMID 19726602›Full record

ArticleJournal of clinical microbiology2009

Multisite comparison of anti-human immunodeficiency virus microbicide activity in explant assays using a novel endpoint analysis.

Nicola Richardson-Harman, Carol Lackman-Smith, Patricia S Fletcher, Peter A Anton, James W Bremer, Charlene S Dezzutti, Julie Elliott, Jean-Charles Grivel, Patricia Guenthner, Phalguni Gupta and 9 more

Open access · greenAbstract readComparative StudyEvaluation StudyMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

43 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
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  4. Trial
  5. Trial
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  7. Analytical Advances in the Ex Vivo Challenge Efficacy Assay.AIDS research and human retroviruses · 2017
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. AnbioRxiv : the preprint server for biology · 2026
    Article
  13. Article
  14. AIDS research and human retroviruses · 2023
    Article
  15. Article
  16. Article
  17. Review
  18. Estradiol inhibits HIV-1Scientific reports · 2022
    Article
  19. Article
  20. 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

19 authors at 9 institutions in 2 countries.

Nicola Richardson-HarmanSouthern Research Institute, 431 Aviation Way, Frederick, MD 21701, USA.
Carol Lackman-Smith
Patricia S Fletcher
Peter A Anton
James W Bremer
Charlene S Dezzutti
Julie Elliott
Jean-Charles Grivel
Patricia Guenthner
Phalguni Gupta
Maureen Jones
Nell S Lurain
Leonid B Margolis
Swarna Mohan
Deena Ratner
Patricia Reichelderfer
Paula Roberts
Robin J Shattock
James E Cummins
Southern Research Institute · USUniversity of Pittsburgh · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USRush University Medical Center · USSt George's, University of London · GBUniversity of California, Los Angeles · USMagee-Womens Research Institute · USNational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USNational Institutes of Health · US

Funding

Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
Regulatory compliance and human subjects safetyU19AI060614 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ANTON, PETER A · 2004 to 2009
$19.1M
NIAID NIH HHS N01 AI050044NIAID NIH HHS U01 AI068633NIAID NIH HHS U19 AI060614
6 · The paper itself

Abstract

Microbicide candidates with promising in vitro activity are often advanced for evaluations using human primary tissue explants relevant to the in vivo mucosal transmission of human immunodeficiency virus type 1 (HIV-1), such as tonsil, cervical, or rectal tissue. To compare virus growth or the anti-HIV-1 efficacies of candidate microbicides in tissue explants, a novel soft-endpoint method was evaluated to provide a single, objective measurement of virus growth. The applicability of the soft endpoint is shown across several different ex vivo tissue types, with the method performed in different laboratories, and for a candidate microbicide (PRO 2000). The soft-endpoint method was compared to several other endpoint methods, including (i) the growth of virus on specific days after infection, (ii) the area under the virus growth curve, and (iii) the slope of the virus growth curve. Virus growth at the assay soft endpoint was compared between laboratories, methods, and experimental conditions, using nonparametric statistical analyses. Intra-assay variability determinations using the coefficient of variation demonstrated higher variability for virus growth in rectal explants. Significant virus inhibition by PRO 2000 and significant differences in the growth of certain primary HIV-1 isolates were observed by the majority of laboratories. These studies indicate that different laboratories can provide consistent measurements of anti-HIV-1 microbicide efficacy when (i) the soft endpoint or another standardized endpoint is used, (ii) drugs and/or virus reagents are centrally sourced, and (iii) the same explant tissue type and method are used. Application of the soft-endpoint method reduces the inherent variability in comparisons of preclinical assays used for microbicide development.

Indexed as

Anti-Infective AgentsCervix UteriFemaleHIV-1HumansIn Vitro TechniquesMaleMicrobial Sensitivity TestsMucous MembranePalatine TonsilRectumReproducibility of ResultsVirus ReplicationAnti-Infective Agents

Identifiers

PMID19726602
PMCPMC2772583
OpenAlexW2119838983

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.