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

HIV Infections Clinical Trial

Official title:

Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959413
• Other study ID #: ACTG A5254
• Secondary ID: 1U01AI068636
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: March 17, 2015
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: March 2015
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Haiti	Les Centres GHESKIO CRS (30022)	Bicentenaire	Port-au-Prince
United States	The Ponce de Leon Ctr. CRS (5802)	Atlanta	Georgia
United States	Unc Aids Crs (3201)	Chapel Hill	North Carolina
United States	Case CRS (2501)	Cleveland	Ohio
United States	NY Univ. HIV/AIDS CRS (401)	New York	New York
United States	Ucsf Aids Crs (801)	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presumptive clinical diagnoses of oral mucosal diseases		At study visit	No
Primary	HIV-1 viral load in throat wash.		At study visit	No
Primary	HIV-1 viral load in plasma		At study visit	No
Primary	Candida CFU level as measured in CFU/mL of throat wash solution.		At study visit	No
Secondary	Prevalence of HIV-1 related oral mucosal lesions		At study visit	No
Secondary	KSHV DNA viral load in throat wash		At study visit	No
Secondary	CMV DNA load in throat wash		At study visit	No
Secondary	Oral candidal genotypes		At study visit	No
Secondary	Antifungal resistance as measured by MIC		At study visit	No
Secondary	HSV-1 DNA viral load in throat wash		At study visit	No
Secondary	EBV DNA viral load in throat wash		At study visit	No