Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219362
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2005-09-16
Brief Title:
Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients
Sponsor:
Objectif Recherche Vaccins SIDA
Organization:
Objectif Recherche Vaccins SIDA
Study Overview
Official Title:
A Phase II Randomized Placebo-controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2009-11
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:
MANON 02
Brief Summary:
Prior pilot studies have shown that four monthly injections of ALVAC-HIV vCP1433 are immunogenic in 60 HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV vCP1452 by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later
Detailed Description:
Manon 02 is a phase II multicentre randomized placebo-controlled study with 3 arms comprising 2 steps
Step I Immunization phase from W0 to W24 on HAART
The immunization will be administered by intramuscular injection
Arm A one injection of vCP1452 at W0 W4 W8 and W20 HAART for a total of 4 injections Arm B one injection of vCP1452 at W4 W8 and W20 HAART for a total of 3 injections Arm C one injection of placebo at W0 W4 W8 and W20 HAART for a total of 4 injections or at W4 W8 and W20 HAART for a total of 3 injections
Step II Post immunization phase from W24 to W48 off HAART
Discontinuation of antiretroviral therapy ARV from W24 to W48
The ARV treatment interruption will be proposed at W24 4 weeks after the last immunization to patient who had completed their immunization phase and have CD4 cell counts 350 cellsmm3 and HIV plasma RNA 400 cpml
In order to be able to evaluate the capacity of the immune response to reduce the viral replication a period of 16 weeks of interruption is recommended from W24 to W40
Resumption of antiretroviral therapy
From W24 to W40 During this 16 weeks period in case of a decline of CD4 cell counts below 250 cellsmm3 or of a loss of CD4 greater than 50 of the baseline value HAART will be restarted
From W40 to W48 HAART should be reintroduced if HIV-1 RNA levels 50 000 cpml on 2 consecutive measurements at two weeks interval even if the CD4 counts are above 250 cellsmm3
Step I Immunization phase from W0 to W24 on HAART
The immunization will be administered by intramuscular injection
Arm A one injection of vCP1452 at W0 W4 W8 and W20 HAART for a total of 4 injections Arm B one injection of vCP1452 at W4 W8 and W20 HAART for a total of 3 injections Arm C one injection of placebo at W0 W4 W8 and W20 HAART for a total of 4 injections or at W4 W8 and W20 HAART for a total of 3 injections
Step II Post immunization phase from W24 to W48 off HAART
Discontinuation of antiretroviral therapy ARV from W24 to W48
The ARV treatment interruption will be proposed at W24 4 weeks after the last immunization to patient who had completed their immunization phase and have CD4 cell counts 350 cellsmm3 and HIV plasma RNA 400 cpml
In order to be able to evaluate the capacity of the immune response to reduce the viral replication a period of 16 weeks of interruption is recommended from W24 to W40
Resumption of antiretroviral therapy
From W24 to W40 During this 16 weeks period in case of a decline of CD4 cell counts below 250 cellsmm3 or of a loss of CD4 greater than 50 of the baseline value HAART will be restarted
From W40 to W48 HAART should be reintroduced if HIV-1 RNA levels 50 000 cpml on 2 consecutive measurements at two weeks interval even if the CD4 counts are above 250 cellsmm3
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