Status:
COMPLETED
Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
The mouth may play an important part in monitoring HIV progression. Mucosal lesions of the mouth are often the first sign of infection and their development in already diagnosed individuals indicates ...
Detailed Description
The oral cavity has been found to play an important role in monitoring the progression of HIV infection. The occurrence of specific lesions, mainly oral candidiasis and hairy leukoplakia, is strongly ...
Eligibility Criteria
Inclusion
- HIV-1 infection, as documented by any rapid test or licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
- CD4+ cell count obtained ≤ 60 days prior to study entry
- Plasma HIV-1 RNA levels obtained ≤ 60 days prior to study entry
- If receiving ART, participants must be on same ART regimen for at least 12 weeks immediately prior to study entry
- If study participants are not currently on an ART regimen, they must have not discontinued ART therapy within 30 days prior to study entry
- Ability and willingness of study participant or legal guardian/representative to provide informed consent
Exclusion
- History of head and/or neck radiation secondary to malignancy
- History of any HIV-1 therapeutic related vaccines
- Use of any systemic anti-fungal in the 90 days prior to entry
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00959413
Start Date
September 1 2009
End Date
September 1 2012
Last Update
March 18 2015
Active Locations (6)
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1
Ucsf Aids Crs (801)
San Francisco, California, United States, 94110
2
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States, 30308
3
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States, 10016
4
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States, 27514