CClinicalTrials.gg
CompletedNCT01344642Updated Apr 29, 2011

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

An observational study in HIV Infections, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-29.

Sponsored by Ottawa Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • HIV
  • RNA
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 40 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Not fitting one of the 4 groups
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
06

Study locations

1 site
  • The Ottawa Hospital, General Campus
    Ottawa, Ontario K1H 8L6, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01344642
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
DNA Genotek (has supplied the kits)
First posted
Apr 29, 2011
Start date
Oct 2007
Primary completion
May 2008
Completion
Dec 2010
Last update
Apr 29, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion