Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit
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The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.
Condition or disease
There is an important need for a rapid, non-invasive, sensitive and specific method for detection of HIV RNA, particularly in clinical settings in which patients at risk for HIV exposure are assessed and screened. A rapid and non-invasive method for quantitative testing of HIV RNA would be also valuable to monitor suppression of HIV RNA as a primary surrogate marker of combination antiretroviral therapy efficacy. An Ottawa-based biotech company (DNA Genotek Inc) has developed and sells to research and clinical labs world-wide a kit (Oragene� DNA Self-collection kit) that permits the collection, stabilization at room temperature, and purification of DNA present in saliva. They have recently developed a kit (Oragene��RNA) that is purported to stabilize RNA in saliva, a non-invasive source of a biological fluid.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV monoinfected HIV-HCV co-infected HIV and HCV uninfected control
Four groups of 10 patients each will be recruited:
Controls (HIV and HCV seronegative by previous testing)
HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. No concurrent HCV infection.
HIV seropositive with HIV RNA <50 copies/mL as a consequence of combination antiretroviral therapy use. No concurrent HCV infection.
HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. HCV RNA positive and not on antiviral therapy.