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

August 12, 2009
April 9, 2013
September 2009
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00959413 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Samples of saliva and blood will be kept

Non-Probability Sample

HIV-infected individuals

HIV Infections
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Haiti
 
NCT00959413
ACTG A5254, 1U01AI068636
No
AIDS Clinical Trials Group
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
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
AIDS Clinical Trials Group
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP