NCT00959413|Completed
Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
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Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
Sponsor study identifier
Secondary identifiers
NIH
observational
328
2 countries
6
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)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 disease progression. In addition, saliva may provide a non-invasive way to track viral load. The purpose of this study is to establish standardized practices for examining the mouth and identifying oral mucosal lesions as well as to establish a correlation of viral load with HIV particles found in saliva.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2009
Actual (reported)August 14, 2009
Actual (reported)September 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2012
Actual (reported)September 2012
Actual (reported)Presumptive clinical diagnoses of oral mucosal diseases
At study visit
HIV-1 viral load in throat wash.
At study visit
HIV-1 viral load in plasma
At study visit
Candida CFU level as measured in CFU/mL of throat wash solution.
At study visit
Prevalence of HIV-1 related oral mucosal lesions
At study visit
KSHV DNA viral load in throat wash
At study visit
CMV DNA load in throat wash
At study visit
Oral candidal genotypes
At study visit
Antifungal resistance as measured by MIC
At study visit
Participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than 1,000 copies/ml
Participants who have a CD4 count of 200 cells/mm3 or less and a viral load of 1,000 copies/ml or less
Participants will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is greater than 1,000 copies/ml
Participants will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is 1,000 copies/ml or less
HIV-infected individuals
Ucsf Aids Crs (801)
San Francisco, California, 94110, United States
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, 30308, United States
NY Univ. HIV/AIDS CRS (401)
New York, New York, 10016, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27514, United States
Case CRS (2501)
Cleveland, Ohio, 44106, United States
Les Centres GHESKIO CRS (30022)
Bicentenaire, Port-au-Prince, HT-6110, Haiti
Samples of saliva and blood will be kept
Judith A Aberg, MD
NYU Langone Health
Caroline Shiboski, DDS, MPH, PhD
Department of Orofacial Sciences, University of California, San Francisco
328 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2009
First Posted
August 14, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults
Contact the study team to confirm eligibility.
Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
March 18, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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