Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

This study has been completed.

Sponsor:

Collaborator:

Columbia University

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004781

First received: February 24, 2000

Last updated: June 23, 2005

Last verified: February 1997

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1989

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004781 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Primary Purpose: Screening

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

HIV Infections
Candidiasis, Oral

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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"

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00004781

Other Study ID Numbers ^ICMJE

199/11861, CU-SDOS-5059

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborators ^ICMJE

Columbia University

Investigators ^ICMJE

Study Chair:

Ira B. Lamster

Columbia University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

February 1997

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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