Clinical trial NCT00959413: Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
Official title: Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-08-14
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected individuals

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Presumptive clinical diagnoses of oral mucosal diseases
timeFrame: At study visit
measure: HIV-1 viral load in throat wash.
timeFrame: At study visit
measure: HIV-1 viral load in plasma
timeFrame: At study visit
measure: Candida CFU level as measured in CFU/mL of throat wash solution.
timeFrame: At study visit
Secondary outcomes:
measure: Prevalence of HIV-1 related oral mucosal lesions
timeFrame: At study visit
measure: KSHV DNA viral load in throat wash
timeFrame: At study visit
measure: CMV DNA load in throat wash
timeFrame: At study visit
measure: Oral candidal genotypes
timeFrame: At study visit
measure: Antifungal resistance as measured by MIC
timeFrame: At study visit
measure: HSV-1 DNA viral load in throat wash
timeFrame: At study visit
measure: EBV DNA viral load in throat wash
timeFrame: At study visit
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf Aids Crs (801)
state: California
city: Atlanta
country: United States
facility: The Ponce de Leon Ctr. CRS (5802)
state: Georgia
city: New York
country: United States
facility: NY Univ. HIV/AIDS CRS (401)
state: New York
city: Chapel Hill
country: United States
facility: Unc Aids Crs (3201)
state: North Carolina
city: Cleveland
country: United States
facility: Case CRS (2501)
state: Ohio
city: Bicentenaire
country: Haiti
facility: Les Centres GHESKIO CRS (30022)
state: Port-au-Prince
Study officials:
affiliation: NYU Langone Health
name: Judith A Aberg, MD
role: STUDY_CHAIR
affiliation: Department of Orofacial Sciences, University of California, San Francisco
name: Caroline Shiboski, DDS, MPH, PhD
role: STUDY_CHAIR
References: