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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00196651
• Other study ID #: ANRS 095 PRIMOVAC
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: August 2000
• Est. completion date: February 2004

Study information

• Verified date: September 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• IL-2

Biological:
• LIPO-6T

• ALVAC VIH 1433

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Aventis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Secondary	Safety of IL-2, ALVAC and LIPO-6T
Secondary	Tolerability of HAART
Secondary	Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
Secondary	Evolution on immune response and predictive value of immunologic parameters on viral load