title: Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oral and Maxillofacial Pathology, Radiology and Medicine, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Phelan
authors.affiliation: Department of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: William R
authors.initials: WR
authors.lastname: Abrams
authors.affiliation: Department of Epidemiology and Health Promotion, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Norman
authors.affiliation: Department of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Yihong
authors.initials: Y
authors.lastname: Li
authors.affiliation: Departments of Medicine and Infectious Diseases and Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.
authors.forename: Maura
authors.initials: M
authors.lastname: Laverty
authors.affiliation: Bluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Corby
authors.affiliation: Bluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Jason
authors.initials: J
authors.lastname: Nembhard
authors.affiliation: Bluestone Center for Clinical Research, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Dinah
authors.initials: D
authors.lastname: Neri
authors.affiliation: Department of Basic Sciences and Craniofacial Biology, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Cheryl A
authors.initials: CA
authors.lastname: Barber
authors.affiliation: Departments of Medicine and Infectious Diseases and Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Aberg
authors.affiliation: Department of Epidemiology and Health Promotion, New York University College of Dentistry, New York, New York, United States of America.
authors.forename: Gene S
authors.initials: GS
authors.lastname: Fisch
authors.affiliation: Department of Medicine, Division of Gastroenterology, New York University Langone Medical Center, New York, New York, United States of America.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Poles
authors.affiliation: Department 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.
authors.forename: Daniel
authors.initials: D
authors.lastname: Malamud
mesh_terms: D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D018414:CD8-Positive T-Lymphocytes / Q000166:cytology; D016022:Case-Control Studies; D002452:Cell Count; D015988:Cohort Effect; D003731:Dental Caries / Q000150:complications; D003945:Diagnosis, Oral; D015340:Epidemiologic Research Design; D005260:Female; D041981:Gastrointestinal Tract / Q000276:immunology / Q000382:microbiology / Q000821:virology*; D015658:HIV Infections / Q000150:complications / Q000276:immunology* / Q000382:microbiology*; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D007113:Immunity, Innate; D008137:Longitudinal Studies; D008297:Male; D064307:Microbiota; D009055:Mouth / Q000276:immunology / Q000382:microbiology / Q000821:virology*; D012367:RNA, Viral / Q000378:metabolism; D012995:Solubility
chemical_list: D012367:RNA, Viral