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

Completed

• Conditions: HIV Infections

• Registration Number: NCT01344642
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-21
• Primary Completion: 2008-05
• Status Verified: 2008-10
• Study Completion: 2010-12
• Study First Submitted QC: 2011-04-28
• Last Update Submitted: 2011-04-28
• Study First Posted: 2011-04-29
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• Not fitting one of the 4 groups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada