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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00959413

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

328

Starts

2009-09-01

Expected to finish

2012-09-01

Last updated by the study team

2015-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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