HIV InfectionsNCT00004781
Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
An observational study of HIV Infections and Candidiasis, Oral, run by National Institute of Dental and Craniofacial Research (NIDCR).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Candidiasis, Oral
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 1989to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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"
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Candidiasis, Oral
- Keywords
- HIV-associated candidiasis, candidiasis, disease-related problem/condition, fungal infection, immunologic disorders and infectious disorders, infection, rare disease
- Medical subject headings
- HIV Infections, Candidiasis, Oral, Candidiasis, Mycoses, Immune System Diseases, Communicable Diseases, Infections, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Columbia University
- Investigators
- Ira B. Lamster, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004781
- Sponsor's protocol ID
- 199/11861
- Other IDs
- CU-SDOS-5059
- Status last verified
- Feb 1997
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
- ClinicalTrials.gov ID
- NCT00004781
- Acronym / sponsor ID
- 199/11861
- Conditions
- HIV Infections, Candidiasis, Oral
- Keywords
- HIV-associated candidiasis, candidiasis, disease-related problem/condition, fungal infection, immunologic disorders and infectious disorders, infection, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Collaborators
- Columbia University
- Study start
- Sep 1989
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira B. Lamster study chair
Columbia University
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Candidiasis, Oral, run by National Institute of Dental and Craniofacial Research (NIDCR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.