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

• 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 ]
  

• 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 ]
  

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.