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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 2

Conditions

HIV Infection

Treatments

Drug: IL-2

Biological: ALVAC VIH 1433

Biological: LIPO-6T

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00196651

ANRS 095 PRIMOVAC

Details and patient eligibility

About

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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