Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
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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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | December 2001 |
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 |
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| 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 | |
| Principal Investigator: | J Angel, MD | Ottawa Hospital Research Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00440206 History of Changes |
| Other Study ID Numbers: | 2002060-01H |
| Study First Received: | February 22, 2007 |
| Last Updated: | February 26, 2007 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ottawa Hospital Research Institute:
|
HIV Immune Markers |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013