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

September 13, 2005
May 22, 2012
April 2004
July 2010   (final data collection date for primary outcome measure)
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 ]
Time to detectable virus in the Remune plus ALVAC group and the placebo group (between group t-test)
Complete list of historical versions of study NCT00212888 on ClinicalTrials.gov Archive Site
  • 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 ]
-Time to detectable virus in the Alvac alone group and the placebo group. -Time to rebound of plasma HIV RNA level to 10,000 copies/ml -Viral set-point -Magnitude of viral rebound -HIV-specific immune function at week 48
Not Provided
Not Provided
 
Combination Vaccination Before HIV Treatment Interruption
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

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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
HIV Infections
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.
Not Provided
Angel JB, Routy JP, Tremblay C, Ayers D, Woods R, Singer J, Bernard N, Kovacs C, Smaill F, Gurunathan S, Sekaly RP. A randomized controlled trial of HIV therapeutic vaccination using ALVAC with or without Remune. AIDS. 2011 Mar 27;25(6):731-9. doi: 10.1097/QAD.0b013e328344cea5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00212888
2000456-01H, CTA file 9427-C1574-32C
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
  • Canadian Institutes of Health Research (CIHR)
  • Ontario HIV Treatment Network
  • CIHR Canadian HIV Trials Network
Principal Investigator: Jonathan B Angel, MD OHRI
Ottawa Hospital Research Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP