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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
  Purpose

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


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344642

Locations
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
DNA Genotek (has supplied the kits)
  More Information

No publications provided

Responsible Party: Curtis Cooper, OHRI
ClinicalTrials.gov Identifier: NCT01344642     History of Changes
Other Study ID Numbers: 2007614-01H
Study First Received: April 21, 2008
Last Updated: April 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
HIV
RNA

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014