NCT01344642

Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.

Detailed description

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.

Conditions

• HIV Infections

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-05-01
• Completion: 2010-12-01
• First posted: 2011-04-29
• Last updated: 2011-04-29

Locations

1 site across 1 country: Canada