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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV RNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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OHRI

Locations

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The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2007614-01H

Identifier Type: -

Identifier Source: org_study_id