Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00959413
First received: August 12, 2009
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Presumptive clinical diagnoses of oral mucosal diseases [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • HIV-1 viral load in throat wash. [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • HIV-1 viral load in plasma [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • Candida CFU level as measured in CFU/mL of throat wash solution. [ Time Frame: At study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of HIV-1 related oral mucosal lesions [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • KSHV DNA viral load in throat wash [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • CMV DNA load in throat wash [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • Oral candidal genotypes [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • Antifungal resistance as measured by MIC [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • HSV-1 DNA viral load in throat wash [ Time Frame: At study visit ] [ Designated as safety issue: No ]
  • EBV DNA viral load in throat wash [ Time Frame: At study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples of saliva and blood will be kept


Enrollment: 328
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected individuals

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959413

Locations
United States, California
Ucsf Aids Crs (801)
San Francisco, California, United States, 94110
United States, Georgia
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States, 30308
United States, New York
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States, 10016
United States, North Carolina
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Case CRS (2501)
Cleveland, Ohio, United States, 44106
Haiti
Les Centres GHESKIO CRS (30022)
Bicentenaire, Port-au-Prince, Haiti, HT-6110
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Judith A Aberg, MD New York University School of Medicine
Study Chair: Caroline Shiboski, DDS, MPH, PhD Department of Orofacial Sciences, University of California, San Francisco
  More Information

No publications provided

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00959413     History of Changes
Other Study ID Numbers: ACTG A5254, 1U01AI068636
Study First Received: August 12, 2009
Last Updated: April 9, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014