NCT00004781

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1989

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1997

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsCandidiasis, Oral

Keywords

HIV-associated candidiasiscandidiasisdisease-related problem/conditionfungal infectionimmunologic disorders and infectious disordersinfectionrare disease

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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"

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Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsCandidiasis, OralCandidiasisMycosesImmune System DiseasesCommunicable DiseasesInfectionsRare Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesBacterial Infections and MycosesMouth DiseasesStomatognathic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ira B. Lamster

    Columbia University

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

September 1, 1989

Last Updated

June 24, 2005

Record last verified: 1997-02