Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

HIV Infections Clinical Trial

Official title:

Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440206
• Other study ID #: 2002060-01H
• Status: Completed
• Phase: N/A
• First received: February 22, 2007
• Last updated: February 26, 2007
• Start date: September 2001
• Est. completion date: December 2001

Study information

• Verified date: February 2007
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Description:

Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be HIV infected

• must be ≥18 years old

• must have been taking the same combination ARV regimen (≥3 drugs) for at least 3 months.

• Must be experiencing virologic failure (viral load ≥50 copies/mL on two occasions at least 2 weeks apart).

• must be changed to a salvage antiretroviral regimen

• Patient has to have signed and dated a full infomred consent.

Exclusion Criteria:

• Patient with any of the following abnormal laboratory test results in the previous 3 months:

• Hemaglobin <100 g/L

• Platelet count <20,000 cells/L

• INR ≥3.5 IU

• PTT ≥60 IU

• Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Canada	McMaster Health Science Center	Hamilton	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Maple Leaf Clinic	Toronto	Ontario
Canada	Windsor Regional Hospital	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada,