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Combination Vaccination Before HIV Treatment Interruption

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Remune and ALVAC
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital, General Campus
  • CHUM Hotel-Dieu
  • Montreal Chest Institute

Outcomes

Primary Outcome Measures

Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group

Secondary Outcome Measures

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
Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.
Magnitude of Viral Rebound
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.
HIV-specific Immune Function

Full Information

First Posted
September 13, 2005
Last Updated
March 19, 2019
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Ontario HIV Treatment Network, CIHR Canadian HIV Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00212888
Brief Title
Combination Vaccination Before HIV Treatment Interruption
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Ontario HIV Treatment Network, CIHR Canadian HIV Trials Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Remune and ALVAC
Intervention Description
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 Measure Information:
Title
Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group
Time Frame
Up to week 48
Secondary Outcome Measure Information:
Title
Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group
Time Frame
Up to week 48
Title
Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml
Time Frame
Up to week 48
Title
Viral Set-point
Description
Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.
Time Frame
Up to week 48
Title
Magnitude of Viral Rebound
Description
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.
Time Frame
Up to week 48
Title
HIV-specific Immune Function
Time Frame
at week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan B Angel, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
CHUM Hotel-Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21330911
Citation
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.
Results Reference
derived

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Combination Vaccination Before HIV Treatment Interruption

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