Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056797
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2003-03-24
Brief Title:
Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune Systems Response to HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 IL-2 also known as aldesleukin can increase immune system function in people with HIV infection
Detailed Description:
While the advent of highly active antiretroviral therapy HAART has contributed to the increasing control of HIV infection and viral replication ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals
This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to increase HIV-specific immune responses in HIV infected patients ALVAC vCP1452 vaccine is a recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection The IL-2 is self administered as a daily subcutaneous injection at a low non-toxic dose 2 million units
Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the first 3 months of the study During this time participants will continue on their current antiretroviral medications and have monthly study visits Study visits will include a brief medical interview and physical exam administration of the vaccine and blood tests At the end of 3 months participants will discontinue both their study medications IL-2 and ALVAC or placebo and their antiretroviral medications This Diagnostic Treatment Interruption DTI will continue for a minimum of 3 months During the DTI participants will have weekly study visits in which viral and lymphocyte dynamics are monitored
This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to increase HIV-specific immune responses in HIV infected patients ALVAC vCP1452 vaccine is a recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection The IL-2 is self administered as a daily subcutaneous injection at a low non-toxic dose 2 million units
Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the first 3 months of the study During this time participants will continue on their current antiretroviral medications and have monthly study visits Study visits will include a brief medical interview and physical exam administration of the vaccine and blood tests At the end of 3 months participants will discontinue both their study medications IL-2 and ALVAC or placebo and their antiretroviral medications This Diagnostic Treatment Interruption DTI will continue for a minimum of 3 months During the DTI participants will have weekly study visits in which viral and lymphocyte dynamics are monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AI051181-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AI051181-01A1 |
| 0900-397 | None | None | None |