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Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440206
First Posted: February 26, 2007
Last Update Posted: February 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ontario HIV Treatment Network
Information provided by:
Ottawa Hospital Research Institute
  Purpose
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Estimated Enrollment: 50
Study Start Date: September 2001
Estimated Study Completion Date: December 2001
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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440206


Locations
Canada, Ontario
McMaster Health Science Center
Hamilton, Ontario, Canada, L8N 3Z5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Maple Leaf Clinic
Toronto, Ontario, Canada, M5B 1L6
Toronto, Ontario, Canada, M5R 2M8
Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 1L9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario HIV Treatment Network
Investigators
Principal Investigator: J Angel, MD Ottawa Hospital Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00440206     History of Changes
Other Study ID Numbers: 2002060-01H
First Submitted: February 22, 2007
First Posted: February 26, 2007
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by Ottawa Hospital Research Institute:
HIV
Immune Markers

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases