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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:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196651
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
August 2000
Not Provided
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: IL-2
  • Biological: LIPO-6T
  • Biological: ALVAC VIH 1433
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
February 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196651
ANRS 095 PRIMOVAC
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Aventis Pharmaceuticals
Principal Investigator: Cecile Goujard, MD Hopital Kremlin Bicetre Bicetre France
Study Director: Jean Pierre Aboulker, MD Inserm SC10 France
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP