Condition category
Infections and Infestations
Date applied
16/11/2005
Date assigned
16/11/2005
Last edited
06/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ohri.ca/home.asp

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

Publication citations

Additional files

Editorial Notes