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

This study has been completed.
Sponsor:
Collaborator:
DNA Genotek (has supplied the kits)
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01344642
First received: April 21, 2008
Last updated: April 28, 2011
Last verified: October 2008

April 21, 2008
April 28, 2011
October 2007
May 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01344642 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2010
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01344642
2007614-01H
No
Curtis Cooper, OHRI
Ottawa Hospital Research Institute
DNA Genotek (has supplied the kits)
Not Provided
Ottawa Hospital Research Institute
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP