Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196651
Status:
TERMINATED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides in Patients Treated Early With HAART During Primary Infection
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Randomized Study on HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides LIPO-6T in Patients Treated Early With HAART During Primary Infection ANRS 095 PRIMOVAC
Status:
TERMINATED
Status Verified Date:
2005-09
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:
HIV-specific immune responses are preserved in patients treated early during primary infectionThe trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation
Detailed Description:
HIV-specific immune responses are preserved in patients treated early during primary infection The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuationPatients treated with HAART are randomized to 3 armsarm1 HAART alone arm2 with 5 cycles of IL-2 at wk0 8 16 24 and 32arm3 4 injections of Alvac-HIV 1433 and LIPO-6T at wk048 followed by 3 cycles of IL-2 at w 16 24 and 32 HAART is stopped at wk 40 in patient with undetectable plasma viral load Viral loads and HIV-specific responses are monitored during the therapeutic period and after HAART interruption until w52 HAARTis rei-initiated with viral failure
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