Contact information
Type
Scientific
Primary contact
Dr Jonathan Benjamin Angel
ORCID ID
Contact details
Ottawa Hospital - General Campus
Division of Infectious Diseases
501 Smyth Rd
Ottawa
K1H 8L6
Canada
+1 613 737 8442
jangel@ohri.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HCT-44179
Study information
Scientific title
A pilot study to determine the impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by a scheduled interruption of antiretroviral therapy on HIV-specific immune function by a scheduled virologic rebound in patients with prolonged viral suppression
Acronym
Study hypothesis
Human Immunodeficiency Virus (HIV) vaccination results in delayed rebound in plasma Viral Load (pVL) after an interruption of Anti-Retroviral Therapy (ART) compared to an interruption of ART without prior vaccination.
Ethics approval
Ottawa Hospital Research Ethics Board Ottawa approved on the 22nd May 2002
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Human Immunodeficiency Virus (HIV)
Intervention
1. Remune™ (1 ml intramuscular [im]) at weeks 0, 12, and 20
2. ALVAC (1 ml im) at weeks 8, 12, 16, and 20
Trial details received 12 September 2005
Intervention type
Drug
Phase
Not Applicable
Drug names
Remune™, ALVAC
Primary outcome measures
Time to virologic rebound.
Secondary outcome measures
1. To determine if, in patients with prolonged suppression of viral replication, therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in viral rebound to detectable levels (greater than 50 copies/ml) compared to a scheduled interruption of antiretroviral therapy without prior vaccination (vaccine placebo)
2. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV Ribonucleic Acid (RNA) level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination
3. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV RNA level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination
4. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination
5. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination
6. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination
7. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination
8. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function (at week 48) compared to vaccination prior to interruption of therapy (week 24)
9. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function compared to scheduled interruption of therapy without prior vaccination (week 48)
10. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function compared to scheduled interruption of therapy without prior vaccination (week 48)
11. To determine if therapeutic HIV vaccination with Remune™ and ALVAC results in improved HIV-specific immune function (in particular, HIV-specific CTL activity) compared to vaccination with ALVAC alone
12. To determine if therapeutic HIV vaccination with Remune™ and ALVAC results in improved control of viral replication (time to rebound, time to 10,000 copies/ml, magnitude of rebound, viral set-point) compared to vaccination with ALVAC alone
13. To determine which immunologic measures correlate with the rapidity and magnitude of virologic rebound after therapy interruption
14. To determine the safety of a complex immune intervention
Overall trial start date
01/04/2001
Overall trial end date
31/03/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. HIV positive CD4 greater than 500
2. Age 18 years and older, either sex
3. CD4 nadir greater than 250
4. Viral load less than 50 for greater than 2 years
5. Receiving a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients with previous Acquired Immunodeficiency Syndrome (AIDS) defining opportunistic infections, previous cancer chemotherapy or other system immunosuppressive therapy
2. Patients with concurrent infections with hepatitis C or hepatitis B or any other acute illness
Recruitment start date
01/04/2001
Recruitment end date
31/03/2003
Locations
Countries of recruitment
Canada
Trial participating centre
Ottawa Hospital - General Campus
Ottawa
K1H 8L6
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (Canada)
Sponsor details
501 Smyth Road
Ottawa
K1H 8L6
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: HCT-44179)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ontario HIV Treatment Network (Canada)
Alternative name(s)
OHTN
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Canada
Funder name
Aventis (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Immune Response Corp. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Network for Vaccines and Immunotherapeutics (CANVAC) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary