Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013663
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2001-03-27
Brief Title:
Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
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
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if HIV-specific canarypox vaccine andor interleukin-2 IL-2 will control viral load amount of HIV in the blood after HIV treatment is withdrawn for a certain time period
Detailed Description:
Step I In addition to continuing HAART patients are randomized into 1 of the following 4 arms
A Immunization placebo B Immunization with the canarypox HIV-vaccine vCP1452 C Daily low-dose IL-2 immunization placebo or D Daily low-dose IL-2 canarypox HIV-vaccine vCP1452 Patients on Arms A B C and D receive vaccine or vaccine placebo injections at Weeks 0 4 8 and 12 Patients on Arms C and D receive IL-2 by self-injection HAART is not provided as part of this study
Step II Patients on all arms A B C and D who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy After 12 weeks of Step II patients whose viral load remains below 30000 copiesml remain on Step II off HAART and continue weekly viral load monitoring Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30000 copiesml on 3 successive determinations or their CD4 count decreases to less than 200 cellsmm3 or less than 50 percent of the baseline CD4 T cell concentration on 2 successive occasions
A Immunization placebo B Immunization with the canarypox HIV-vaccine vCP1452 C Daily low-dose IL-2 immunization placebo or D Daily low-dose IL-2 canarypox HIV-vaccine vCP1452 Patients on Arms A B C and D receive vaccine or vaccine placebo injections at Weeks 0 4 8 and 12 Patients on Arms C and D receive IL-2 by self-injection HAART is not provided as part of this study
Step II Patients on all arms A B C and D who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy After 12 weeks of Step II patients whose viral load remains below 30000 copiesml remain on Step II off HAART and continue weekly viral load monitoring Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30000 copiesml on 3 successive determinations or their CD4 count decreases to less than 200 cellsmm3 or less than 50 percent of the baseline CD4 T cell concentration on 2 successive occasions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0900-397 | None | None | None |