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Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
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.
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 associated with a low CD4 cell count and a higher plasma viral load. Furthermore, even though the prevalence of specific oral lesions like candidiasis, hairy leukoplakia, and Kaposi sarcoma (KS) has been found to be lower among patients on highly active antiretroviral therapy (HAART), other oral lesions such as warts have been found to be more prevalent in this population. In addition, saliva has been shown to harbor viral particles, antibodies, and cytokines, and may represent an easily and noninvasively collected specimen for various diagnostic assays, including early diagnosis of HIV. The purpose of this study is to establish a set of standardized practices for examining and diagnosing oral mucosal lesions and to establish a correlation between the amount of HIV found in the saliva with viral load. Participants in this study will attend only one screening visit and study visit and will be assigned to one of four groups based on viral load and CD4 count. Group A will consist of participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than 1000 copies/ml. Group B will be made up of participants who have a CD4 count of 200 cells/mm3 or less and a viral load of 1000 copies/ml or less. Group C participants will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is greater than 1000 copies/ml. Participants making up Group D will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is 1000 copies/ml or less. All participants will have a medical history taken and blood collected as well as performing a throat wash collection and whole saliva collection. In addition, two oral exams will be performed at the study visit.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ucsf Aids Crs (801)
San Francisco, California, United States
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
Case CRS (2501)
Cleveland, Ohio, United States
Les Centres GHESKIO CRS (30022)
Bicentenaire, Port-au-Prince, Haiti
Start Date
September 1, 2009
Primary Completion Date
September 1, 2012
Completion Date
September 1, 2012
Last Updated
March 18, 2015
328
ACTUAL participants
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330