Status:
COMPLETED
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Ontario HIV Treatment Network
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2001
Trial Type :
OBSERVATIONAL
End Date :
December 1 2001
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00440206
Start Date
September 1 2001
End Date
December 1 2001
Last Update
February 27 2007
Active Locations (5)
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1
McMaster Health Science Center
Hamilton, Ontario, Canada, L8N 3Z5
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
Maple Leaf Clinic
Toronto, Ontario, Canada, M5B 1L6
4
Toronto, Ontario, Canada, M5R 2M8