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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital, General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV monoinfected HIV-HCV co-infected HIV and HCV uninfected control

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: DNA Genotek (has supplied the kits)

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 21, 2008
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: HIV; RNA
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2007614-01H