Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)

This study has been completed.
Sponsor:
Collaborator:
Chiron Corporation
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00120185
First received: July 8, 2005
Last updated: December 21, 2011
Last verified: December 2011

July 8, 2005
December 21, 2011
December 2003
November 2006   (final data collection date for primary outcome measure)
Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96
Same as current
Complete list of historical versions of study NCT00120185 on ClinicalTrials.gov Archive Site
  • Group B or C events (1993 CDC classification of HIV infection)
  • Initiation of antiretroviral therapy
  • Evolution of the CD4 count during the study
  • Time to the first visit with a CD4 count below 300/mm3
  • Tolerance of IL-2
  • Evolution of the plasma HIV RNA load
  • Evolution of the HIV DNA level in PBMCs
  • Quality of life at W96
  • Assessment of lipodystrophy at W96
  • Immunological substudies (CD4 homeostasis, anti HIV cellular immune responses) at W96
Same as current
Not Provided
Not Provided
 
Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)
Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 (IL-2) in Antiretroviral Naïve HIV-1-Infected Subjects With a CD4 Cell Count Above 300/mm3. ANRS 119 Trial INTERSTART

Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its activity in patients without antiretroviral therapy is unknown. This study will test the efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500/m3.

IL-2 is produced naturally in the body and helps CD4 cells multiply. In earlier studies in HIV-infection, most of the patients with a controlled viral load under antiretroviral therapy and a high level of CD4 cell count (over 200/mm3) who received IL-2, experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone. The efficacy of IL-2 when the viral load is high and the patient is not receiving antiretroviral therapy is not known. The purpose of this multicentric national study is to compare the effects of IL-2 versus no treatment in HIV naïve patients. One hundred thirty HIV-1-infected patients, with a CD4 count between 300 and 500/mm3, will be randomly assigned to one of two treatment groups : IL-2 or no treatment. The group with IL-2 will receive a dose of 4.5 million international units by subcutaneous injection twice a day for 5 days (up to a total of 5 cycles, ending at Week 96), the first three cycles 8 weeks apart. Evaluation will be done at week 96. The primary endpoint is the proportion of patients reaching an absolute CD4 count below 300/mm3 at Week 96. Secondary endpoints include the occurrence of HIV-related events, drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Interleukin-2
Not Provided
Molina JM, Levy Y, Fournier I, Hamonic S, Bentata M, Beck-Wirth G, Gougeon ML, Venet A, Madelaine I, Sereni D, Jeanblanc F, Boulet T, Simon F, Aboulker JP; Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 119 Interstart Study Team. Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119). J Infect Dis. 2009 Jul 15;200(2):206-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with proven HIV-1-infection
  • No prior exposition to antiretrovirals
  • CD4 cell count between 300 and 500/mm3
  • Signed written inform consent

Exclusion Criteria:

  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00120185
2004-003897-27, ANRS119 Interstart
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Chiron Corporation
Principal Investigator: Jean-Michel Molina, MD Hopital Saint Louis Paris service des Maladies infectieuses et Tropicales
Study Chair: Jean-Pierre Aboulker, MD Inserm SC10
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

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