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, Gene S. Fisch, Michael A. Poles, Daniel Malamud

Research output: Contribution to journalArticle

Abstract

Introduction: The 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.

Methods: Crosstalk 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.

Results: During 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.

Original languageEnglish (US)
Article numbere112901
JournalPLoS One
Volume9
Issue number11
DOIs
StatePublished - Nov 19 2014

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Crosstalk
mouth
Bacteria
HIV
Longitudinal control
microorganisms
Immune system
Proteome
Viruses
Health
Tissue
HIV infections
Molecules
longitudinal studies
lesions (animal)
HIV Infections
Longitudinal Studies
Opportunistic Infections
infection
Proteins

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes. / Phelan, Joan A.; Abrams, William R.; Norman, Robert G.; Li, Yihong; Laverty, Maura; Corby, Patricia M.; Nembhard, Jason; Neri, Dinah; Barber, Cheryl A.; Aberg, Judith A.; Fisch, Gene S.; Poles, Michael A.; Malamud, Daniel.

In: PLoS One, Vol. 9, No. 11, e112901, 19.11.2014.

Research output: Contribution to journalArticle

Phelan, JA, Abrams, WR, Norman, RG, Li, Y, Laverty, M, Corby, PM, Nembhard, J, Neri, D, Barber, CA, Aberg, JA, Fisch, GS, Poles, MA & Malamud, D 2014, 'Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes', PLoS One, vol. 9, no. 11, e112901. https://doi.org/10.1371/journal.pone.0112901
Phelan, Joan A. ; Abrams, William R. ; Norman, Robert G. ; Li, Yihong ; Laverty, Maura ; Corby, Patricia M. ; Nembhard, Jason ; Neri, Dinah ; Barber, Cheryl A. ; Aberg, Judith A. ; Fisch, Gene S. ; Poles, Michael A. ; Malamud, Daniel. / Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes. In: PLoS One. 2014 ; Vol. 9, No. 11.
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AU - Phelan, Joan A.

AU - Abrams, William R.

AU - Norman, Robert G.

AU - Li, Yihong

AU - Laverty, Maura

AU - Corby, Patricia M.

AU - Nembhard, Jason

AU - Neri, Dinah

AU - Barber, Cheryl A.

AU - Aberg, Judith A.

AU - Fisch, Gene S.

AU - Poles, Michael A.

AU - Malamud, Daniel

PY - 2014/11/19

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N2 - Introduction: The 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.Methods: Crosstalk 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.Results: During 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.

AB - Introduction: The 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.Methods: Crosstalk 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.Results: During 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.

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