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

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.

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