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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: IL-2
* Biological: LIPO-6T
* Biological: ALVAC VIH 1433


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IL-2|nan|
|Biological: LIPO-6T|nan|
|Biological: ALVAC VIH 1433|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection, AIDS Vaccines, ALVAC vaccine, Interleukin-2, Antiretroviral Therapy, Highly Active