Clinical trial NCT00196651: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infection
Keywords: HIV infection
AIDS Vaccines
ALVAC vaccine
Interleukin-2
Antiretroviral Therapy, Highly Active
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Secondary outcomes:
measure: Safety of IL-2, ALVAC and LIPO-6T
measure: Tolerability of HAART
measure: Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
measure: Evolution on immune response and predictive value of immunologic parameters on viral load
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Kremlin Bicetre Bicetre France
name: Cecile Goujard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm SC10 France
name: Jean Pierre Aboulker, MD
role: STUDY_DIRECTOR
References:
citation: Goujard C, Marcellin F, Hendel-Chavez H, Burgard M, Meiffredy V, Venet A, Rouzioux C, Taoufik Y, El Habib R, Beumont-Mauviel M, Aboulker JP, Levy Y, Delfraissy JF; PRIMOVAC-ANRS 095 Study Group. Interruption of antiretroviral therapy initiated during primary HIV-1 infection: impact of a therapeutic vaccination strategy combined with interleukin (IL)-2 compared with IL-2 alone in the ANRS 095 Randomized Study. AIDS Res Hum Retroviruses. 2007 Sep;23(9):1105-13. doi: 10.1089/aid.2007.0047.