Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

This study has been completed.

Sponsors and Collaborators:	Ottawa Health Research Institute Ontario HIV Treatment Network
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00440206

Purpose

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

Condition
HIV Infections

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

Further study details as provided by Ottawa Health 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440206

Locations

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Maple Leaf Clinic
Toronto, Ontario, Canada, M5B 1L6
McMaster Health Science Center
Hamilton, Ontario, Canada, L8N 3Z5
Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 1L9

Toronto, Ontario, Canada, M5R 2M8

Sponsors and Collaborators

Ottawa Health Research Institute

Ontario HIV Treatment Network

Investigators

Principal Investigator:

J Angel, MD

Ottawa Health Research Institute

More Information

Study ID Numbers:	2002060-01H
Study First Received:	February 22, 2007
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00440206
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

HIV
Immune Markers

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009