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Combination Vaccination Before HIV Treatment Interruption

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00212888
First received: September 13, 2005
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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
HIV Infections
 Biological: Remune and ALVAC
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Time to detectable virus in the Remune plus ALVAC group and the placebo group (between group t-test) [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to detectable virus in the ALVAC alone group and the placebo group [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Time to rebound of plasma HIV RNA level to 10,000 copies/ml [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Viral set-point [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Magnitude of viral rebound [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • HIV-specific immune function [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2004
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Remune and ALVAC
    • Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20);
    • Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or
    • Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
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; ALVAC 1 ml i.m.* at weeks 8,12, 16, and 20.

* i.m.: injected in a muscle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212888

Locations
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
CHUM Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Jonathan B Angel, MD OHRI
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00212888     History of Changes
Other Study ID Numbers: 2000456-01H, CTA file 9427-C1574-32C
Study First Received: September 13, 2005
Last Updated: May 22, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
HIV
Vaccination

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 23, 2013