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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344642
• Other study ID #: 2007614-01H
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: April 28, 2011
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	DNA Genotek (has supplied the kits)

Country where clinical trial is conducted

Canada,