Status:
COMPLETED
Combination Vaccination Before HIV Treatment Interruption
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 rebou...
Detailed Description
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; ...
Eligibility Criteria
Inclusion
- Documented HIV infection (by serology)
- HIV RNA level below 50 copies/ml for at least two years
- Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
- Have CD4 counts above 500 cells/ul
- Have CD4/CD8 ratio above 0.5
- Have never had a CD4 count below 250
- No previous AIDS-defining opportunistic infection
- No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses \[\<= 1 month\] of prednisone or its equivalent)
- Able to provide informed consent
Exclusion
- Hepatitis B surface antigen positive
- Hepatitis C antibody positive
- AST, ALT, ALP, creatinine, urea above three times the normal upper limit
- Blood abnormalities (hemoglobin lower than 100, white blood cell count \[WBC\] lower than 1500 or platelets lower than 100)
- Allergies to components of Remune™ or ALVAC
- Contraindications to vaccine components
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00212888
Start Date
April 1 2004
End Date
November 1 2010
Last Update
June 17 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
2
CHUM Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8
3
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4