Evidence map›Paper›PMID 25409430›Full record

ArticlePloS one2014

Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes.

Joan A Phelan, William R Abrams, Robert G Norman, Yihong Li, Maura Laverty, Patricia M Corby, Jason Nembhard, Dinah Neri, Cheryl A Barber, Judith A Aberg and 3 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2014. 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
1.9field-weighted citation impact, top 13% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

13 authors at 6 institutions in 1 country.

Joan A PhelanDepartment of Oral and Maxillofacial Pathology, Radiology and Medicine, New York University College of Dentistry, New York, New York, United States of America.
William R AbramsDepartment of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
Robert G NormanDepartment of Epidemiology and Health Promotion, New York University College of Dentistry, New York, New York, United States of America.
Yihong LiDepartment of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
Maura LavertyDepartments of Medicine and Infectious Diseases and Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.
Patricia M CorbyBluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
Jason NembhardBluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
Dinah NeriBluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
Cheryl A BarberDepartment of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
Judith A AbergDepartments of Medicine and Infectious Diseases and Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.
Gene S FischDepartment of Epidemiology and Health Promotion, New York University College of Dentistry, New York, New York, United States of America.
Michael A PolesDepartment of Medicine, Division of Gastroenterology, New York University Langone Medical Center, New York, New York, United States of America.
Daniel MalamudDepartment of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America; Department of Medicine, New York University School of Medicine, New York, New York, United States of America.
New York University · USIcahn School of Medicine at Mount Sinai · USCenter for Clinical Research (United States) · USNew York College of Health Professions · USNYU Langone Health · USYork University · US

Funding

VIROLOGY COREP30AI027742 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI GORNY, MIROSLAW K · 1989 to 2010
$19.4M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR029893 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI CRONSTEIN, BRUCE NEIL · 2009 to 2011
$17.7M
New York University HIV/AIDS Clinical Trial UnitU01AI069532 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 2007 to 2011
$7.5M
The Proteomic and Functional Profile of HIV Positive SalivaU19DE018385 · NIDCR · NEW YORK UNIVERSITY · PI MALAMUD, DANIEL · 2007 to 2014
$6.6M
NCRR NIH HHS 1UL1RR029893-01NCRR NIH HHS UL1 RR029893NIAID NIH HHS 5P30AI027742NIAID NIH HHS 5U01AI069532NIAID NIH HHS P30 AI027742NIAID NIH HHS U01 AI069532NIDCR NIH HHS U19 DE018385NIDCR NIH HHS U19DE018385
6 · The paper itself

Abstract

introductionThe impaired host defense system in HIV infection impacts the oral and gastrointestinal microbiota and associated opportunistic infections. Antiretroviral treatment is predicted to partially restore host defenses and decrease the oral manifestation of HIV/AIDS. Well-designed longitudinal studies are needed to better understand the interactions of soluble host defense proteins with bacteria and virus in HIV/AIDS. "Crosstalk" was designed as a longitudinal study of host responses along the gastrointestinal (GI) tract and interactions between defense molecules and bacteria in HIV infection and subsequent therapy. PURPOSE: The clinical core formed the infrastructure for the study of the interactions between the proteome, microbiome and innate immune system. The core recruited and retained study subjects, scheduled visits, obtained demographic and medical data, assessed oral health status, collected samples, and guided analysis of the hypotheses. This manuscript presents a well-designed clinical core that may serve as a model for studies that combine clinical and laboratory data.

methodsCrosstalk was a case-control longitudinal clinical study an initial planned enrollment of 170 subjects. HIV+ antiretroviral naïve subjects were followed for 9 visits over 96 weeks and HIV uninfected subjects for 3 visits over 24 weeks. Clinical prevalence of oral mucosal lesions, dental caries and periodontal disease were assessed.

resultsDuring the study, 116 subjects (47 HIV+, 69 HIV-) were enrolled. Cohorts of HIV+ and HIV- were demographically similar except for a larger proportion of women in the HIV- group. The most prevalent oral mucosal lesions were oral candidiasis and hairy leukoplakia in the HIV+ group. DISCUSSION: The clinical core was essential to enable the links between clinical and laboratory data. The study aims to determine specific differences between oral and GI tissues that account for unique patterns of opportunistic infections and to delineate the differences in their susceptibility to infection by HIV and their responses post-HAART.

Indexed as

Epidemiologic Research DesignImmunity, InnateMicrobiotaAdultCase-Control StudiesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCell CountCohort EffectDental CariesDiagnosis, OralFemaleGastrointestinal TractHIV-1HIV InfectionsHumansRNA, Viral

Identifiers

PMID25409430
PMCPMC4237510
OpenAlexW2108826509

What OpenQuestion holds

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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.