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

Phase 2

Terminated

• Conditions: HIV Infection

• Registration Number: NCT00196651
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

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 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 discontinuation.Patients treated with HAART are randomized to 3 arms:arm1 HAART alone; arm2 with 5 cycles of IL-2 at wk0 ,8 ,16 ,24 and 32;arm3 4 injections of Alvac-HIV 1433 and LIPO-6T at wk0,4,8 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 Timeline

• Study Start: 2000-08
• Study Completion: 2004-02
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• History of symptomatic HIV primary infection with p24 positive or incomplete Western Blot
• Treatment beginning before 4W after the first primary infection serology
• HAART with IP or NNRTI since one year, wtih no change since 3 months
• Viral load below 50 cp since 6 months
• PN over 1000/mm3;Hb over 10.5g/l;Platelets over 75000/mm3, creatinine below 1.5N; transaminases below 2.5N

Exclusion Criteria

• Vaccination or chemotherapy or corticosteroid since 3 months
• Evolutive cancer
• pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36

Secondary Outcome Measures

Name	Time	Method
Safety of IL-2, ALVAC and LIPO-6T
Tolerability of HAART
Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
Evolution on immune response and predictive value of immunologic parameters on viral load