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Clinical Trials

MainTitle

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

This study has been terminated
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Aventis Pharmaceuticals

Information provided by (Responsible Party)
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier
NCT00196651

First received: September 12, 2005
Last updated: September 12, 2005
Last Verified: September 2005
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infection

Drug : IL-2
Biological : LIPO-6T
Biological : ALVAC VIH 1433
Phase 2

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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: August 2000
Study Completion Date: February 2004

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196651

Sponsors and Collaborators

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

Investigators

Principal Investigator: Cecile Goujard, MD Hopital Kremlin Bicetre Bicetre France
Study Director: Jean Pierre Aboulker, MD Inserm SC10 France
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00196651   History of Changes  
Other Study ID Numbers: ANRS 095 PRIMOVAC  
Study First Received: September 12, 2005  
Last Updated: September 12, 2005  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.