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Sponsors and Collaborators: |
Ottawa Health Research Institute Canadian Institutes of Health Research (CIHR) Ontario HIV Treatment Network Canadian HIV Trials Network |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00212888 |
The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.
Condition | Intervention | Phase |
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HIV Infections |
Biological: Remune and ALVAC |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Pilot Study to Determine the Impact of Therapeutic HIV Vaccination Followed by a Scheduled Interruption of Antiretroviral Therapy on HIV-Specific Immune Function and Virologic Rebound in Patients With Prolonged Viral Suppression |
Estimated Enrollment: | 60 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2007 |
Volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24.
Dosage:
Remune(TM) 1 ml i.m.* at weeks 0, 12, and 20; ALVAC 1 ml i.m.* at weeks 8,12, 16, and 20.
* i.m.: injected in a muscle
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Ottawa Hospital, General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Jonathan B Angel, MD 613-737-8442 jangel@ottawahospital.on.ca | |
Contact: Nancy Lamoureux, RN 613-737-8209 nlamoureux@ohri.ca | |
Principal Investigator: Jonathan B Angel, MD | |
Canada, Quebec | |
Montreal Chest Institute | Recruiting |
Montreal, Quebec, Canada, H2X 2P4 | |
Contact: Jean-Pierre Routy, MD 514-843-2090 RoutyJP@muhchem.mcgill.ca | |
CHUM Hotel-Dieu | Recruiting |
Montreal, Quebec, Canada, H2W 1T8 | |
Contact: Cécile Tremblay, MD 514-890-8000 c.tremblay@umontreal.ca |
Principal Investigator: | Jonathan B Angel, MD | OHRI |
Study ID Numbers: | 2000456-01H, CTA file 9427-C1574-32C |
Study First Received: | September 13, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00212888 |
Health Authority: | Canada: Health Canada |
HIV Vaccination |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |