NCT01344642

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
Last Updated

April 29, 2011

Status Verified

October 1, 2008

Enrollment Period

7 months

First QC Date

April 21, 2008

Last Update Submit

April 28, 2011

Conditions

HIV Infections

Keywords

HIVRNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Not fitting one of the 4 groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 29, 2011

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Study Completion

December 1, 2010

Last Updated

April 29, 2011

Record last verified: 2008-10

Locations

CA(1)