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Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

Primary Purpose

HIV Infections, Candidiasis, Oral

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring HIV-associated candidiasis, candidiasis, disease-related problem/condition, fungal infection, immunologic disorders and infectious disorders, infection, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Human immunodeficiency virus infection (HIV) seropositive or seronegative At risk for HIV, i.e.: Gay/bisexual men Male intravenous drug users Female intravenous drug users No acquired immunodeficiency syndrome Currently enrolled in Columbia Presbyterian Medical Center protocol "The Natural History and Progression of HIV Infection"

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
    Collaborators
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004781
    Brief Title
    Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 1997
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1989 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
    Collaborators
    Columbia University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Evaluate the development of oral manifestations of human immunodeficiency virus infection in relationship to the onset of immunologic alterations and systemic symptoms in different risk groups: gay/bisexual men, male intravenous drug users, and female intravenous drug users. II. Evaluate the immune and inflammatory response to periodontal and other microbial pathogens. III. Evaluate the bacterial species infecting the oral cavity in patients in these risk groups.
    Detailed Description
    PROTOCOL OUTLINE: Patients undergo a periodontal assessment every 6 months until medically unable to continue. The oral/dental exam includes saliva and gingival crevicular fluid analysis and, as indicated, oral photographs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Candidiasis, Oral
    Keywords
    HIV-associated candidiasis, candidiasis, disease-related problem/condition, fungal infection, immunologic disorders and infectious disorders, infection, rare disease

    7. Study Design

    Enrollment
    250 (false)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Human immunodeficiency virus infection (HIV) seropositive or seronegative At risk for HIV, i.e.: Gay/bisexual men Male intravenous drug users Female intravenous drug users No acquired immunodeficiency syndrome Currently enrolled in Columbia Presbyterian Medical Center protocol "The Natural History and Progression of HIV Infection"
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ira B. Lamster
    Organizational Affiliation
    Columbia University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

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