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
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
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
NCT ID
NCT00004781
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators
Columbia University
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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