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 |
| Secondary identifying numbers | HCT-44179 |
- 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
Scientific
Ottawa Hospital - General Campus
Division of Infectious Diseases
501 Smyth Rd
Ottawa
K1H 8L6
Canada
| Phone | +1 613 737 8442 |
|---|---|
| jangel@ohri.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Remune™, ALVAC |
| Primary outcome measure | 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 study start date | 01/04/2001 |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
K1H 8L6
Canada
Sponsor information
Ottawa Hospital Research Institute (Canada)
Research organisation
Research organisation
501 Smyth Road
Ottawa
K1H 8L6
Canada
| Website | http://www.ohri.ca/home.asp |
|---|---|
"ROR" |
https://ror.org/03c62dg59 |
Funders
Funder type
Industry
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: HCT-44179)
No information available
Ontario HIV Treatment Network (Canada)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- The Ontario Hiv Treatment Network, OHTN
- Location
- Canada
Aventis (Canada)
No information available
Immune Response Corp. (USA)
No information available
Canadian Network for Vaccines and Immunotherapeutics (CANVAC) (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
