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Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

This study has been completed.
Sponsor:
Collaborator:
Ontario HIV Treatment Network
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00440206
First received: February 22, 2007
Last updated: February 26, 2007
Last verified: February 2007

February 22, 2007
February 26, 2007
September 2001
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Complete list of historical versions of study NCT00440206 on ClinicalTrials.gov Archive Site
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Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

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

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2001
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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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00440206
2002060-01H
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Ottawa Hospital Research Institute
Ontario HIV Treatment Network
Principal Investigator: J Angel, MD Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP