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11 February 2012
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| [ Print-friendly version ] |
| The impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by antiretroviral therapy in patients with prolonged viral suppression |
| ISRCTN | ISRCTN87061665 |
| ClinicalTrials.gov identifier | |
| Public title | The impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by antiretroviral therapy in patients with prolonged viral suppression |
| 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 | N/A |
| Serial number at source | HCT-44179 |
| 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. |
| Lay summary | |
| Ethics approval | Ottawa Hospital Research Ethics Board Ottawa approved on the 22nd May 2002 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Human Immunodeficiency Virus (HIV) |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/04/2001 |
| Anticipated end date | 31/03/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
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 |
| Primary outcome measure(s) | Time to virologic rebound. |
| 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 |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: HCT-44179)
2. Ontario HIV Treatment Network (Canada) 3. Aventis (Canada) 4. Immune Response Corp. (USA) 5. Canadian Network for Vaccines and Immunotherapeutics (CANVAC) (Canada) |
| Trial website | |
| Publications | |
| Contact name | Dr Jonathan Benjamin Angel |
| Address |
Ottawa Hospital - General Campus
Division of Infectious Diseases 501 Smyth Rd |
| City/town | Ottawa |
| Zip/Postcode | K1H 8L6 |
| Country | Canada |
| Tel | +1 613 737 8442 |
| Fax | +1 613 737 8164 |
| jangel@ohri.ca | |
| Sponsor | Ottawa Hospital Research Institute (Canada) |
| Address | 501 Smyth Road |
| City/town | Ottawa |
| Zip/Postcode | K1H 8L6 |
| Country | Canada |
| Sponsor website: | http://www.ohri.ca/home.asp |
| Date applied | 16/11/2005 |
| Last edited | 06/03/2009 |
| Date ISRCTN assigned | 16/11/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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