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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-02-29

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.

Conditions

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HIV Infection

Keywords

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HIV infection AIDS Vaccines ALVAC vaccine Interleukin-2 Antiretroviral Therapy, Highly Active

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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IL-2

Intervention Type DRUG

LIPO-6T

Intervention Type BIOLOGICAL

ALVAC VIH 1433

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Cecile Goujard, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Kremlin Bicetre Bicetre France

Jean Pierre Aboulker, MD

Role: STUDY_DIRECTOR

Inserm SC10 France

References

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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.

Reference Type DERIVED

PMID: 17919105 (View on PubMed)

Other Identifiers

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ANRS 095 PRIMOVAC

Identifier Type: -

Identifier Source: org_study_id