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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Actual): 328

Contacts and Locations

Study Locations

• Haiti
  • Port-au-Prince
    • Bicentenaire, Port-au-Prince, Haiti, HT-6110
      • Les Centres GHESKIO CRS (30022)
• United States
  • California
    • San Francisco, California, United States, 94110
      • Ucsf Aids Crs (801)
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Ponce de Leon Ctr. CRS (5802)
  • New York
    • New York, New York, United States, 10016
      • NY Univ. HIV/AIDS CRS (401)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Unc Aids Crs (3201)
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case CRS (2501)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected individuals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
A; Participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than 1,000 copies/ml
B; Participants who have a CD4 count of 200 cells/mm3 or less and a viral load of 1,000 copies/ml or less
C; 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
D; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
HSV-1 DNA viral load in throat wash	At study visit
EBV DNA viral load in throat wash	At study visit

Collaborators and Investigators

• Sponsor: AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Judith A Aberg, MD, NYU Langone Health; Study Chair: Caroline Shiboski, DDS, MPH, PhD, Department of Orofacial Sciences, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (Estimate): August 14, 2009

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ACTG A5254; 1U01AI068636 (U.S. NIH Grant/Contract)