The impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by antiretroviral therapy in patients with prolonged viral suppression

ISRCTN	ISRCTN87061665
DOI	https://doi.org/10.1186/ISRCTN87061665
Protocol serial number	HCT-44179
Sponsor	Ottawa Hospital Research Institute (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: HCT-44179), Ontario HIV Treatment Network (Canada), Aventis (Canada), Immune Response Corp. (USA), Canadian Network for Vaccines and Immunotherapeutics (CANVAC) (Canada)

Submission date: 16/11/2005
Registration date: 16/11/2005
Last edited: 06/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jonathan Benjamin Angel
Scientific

Ottawa Hospital - General Campus
Division of Infectious Diseases
501 Smyth Rd
Ottawa
K1H 8L6
Canada

Phone	+1 613 737 8442
Email	jangel@ohri.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Ottawa Hospital Research Ethics Board Ottawa approved on the 22nd May 2002
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Remune™, ALVAC
Primary outcome measure(s)	Time to virologic rebound.
Key secondary outcome measure(s)	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
Completion date	31/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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)
Key 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
Date of first enrolment	01/04/2001
Date of final enrolment	31/03/2003

Locations

Countries of recruitment

Canada

Study participating centre

Ottawa Hospital - General Campus

Ottawa
K1H 8L6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan