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Combination Vaccination Before HIV Treatment Interruption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00212888
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
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

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 rebound in the amount of HIV virus in the blood.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Remune and ALVAC Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


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.


Primary Outcome Measures :
  1. Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group [ Time Frame: Up to week 48 ]

Secondary Outcome Measures :
  1. Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group [ Time Frame: Up to week 48 ]
  2. Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml [ Time Frame: Up to week 48 ]
  3. Viral Set-point [ Time Frame: Up to week 48 ]
    Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.

  4. Magnitude of Viral Rebound [ Time Frame: Up to week 48 ]
    Magnitude of viral rebound is the amount of HIV viral load an infected person who was previously on ART and suppressed below clinical detection rebounds to following ART stoppage. This will typically be compared to the viral load before starting ART or Viral set-point discussed earlier.

  5. HIV-specific Immune Function [ Time Frame: at week 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212888


Locations
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Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
CHUM Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
CIHR Canadian HIV Trials Network
Investigators
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Principal Investigator: Jonathan B Angel, MD OHRI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00212888    
Other Study ID Numbers: 2000456-01H
CTA file 9427-C1574-32C
First Posted: September 21, 2005    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: March 2019
Keywords provided by Ottawa Hospital Research Institute:
HIV
Vaccination
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases