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Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

NCT ID: NCT00440206

Last Updated: 2007-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-09-30

Study Completion Date

2001-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV Immune Markers

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario HIV Treatment Network

NETWORK

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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J Angel, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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McMaster Health Science Center

Hamilton, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Maple Leaf Clinic

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Windsor Regional Hospital

Windsor, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2002060-01H

Identifier Type: -

Identifier Source: org_study_id