Efficacy of Adding Interleukin-2 to an Optimized Antiretroviral Regimen in HIV Patients in Therapeutic Failure (ANRS123)

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:
NCT00113282
First received: June 7, 2005
Last updated: December 21, 2011
Last verified: June 2009
  Purpose

Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients with a CD4 cell count over 200/mm3, but its activity in patients with treatment failure and low CD4 cell counts is unknown. This study will test the efficacy and safety of IL-2 with an optimized antiretroviral regimen in patients with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml.


Condition Intervention Phase
HIV Infections
Drug: Interleukin-2 (IL-2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Immunological Efficacy of Adding Subcutaneous Interleukin-2 (IL-2) to an Optimized Antiretroviral Regimen in HIV-1-infected Subjects Experiencing Therapeutic Failure on an Ongoing Antiretroviral Combination With a CD4 Cell Count ≤ 200/mm3 ANRS 123 Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52 (W52)

Secondary Outcome Measures:
  • group B or C events (1993 CDC classification of HIV infection)between Week 00 and Week 96
  • median value of the CD4 count at W52
  • evolution of the CD4 count during the study
  • time to the first visit with a CD4 count ≥ 200/mm3
  • tolerance of IL-2
  • tolerance of antiretroviral drugs
  • evolution of the plasma HIV RNA load at W64 and W76
  • evolution of the HIV DNA level in PBMCs at W64 and W76
  • number of modifications of antiretroviral regimen until W52
  • clinical status at W64 and W76
  • CD4 count at W64, W76 and W96
  • plasma HIV RNA load at W64, W76 and W96
  • number of modifications of antiretroviral regimen at W64 and W76
  • proportion of patients increasing their CD4 count over 50/mm3 between Week 00 and Week 24, and between Week 00 and Week 52 [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: June 2004
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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 and a high level of CD4 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 CD4 cell count is low is not known. The purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without IL-2.The choice of the antiretroviral regimen will be made from a genotype resistance test.

Ninety eight HIV-1-infected patients experiencing advanced treatment failure with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml, will be randomly assigned to one of two treatment groups: with or without IL-2.

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 8 cycles, ending at Week 42), the first two cycles 4 weeks apart, the following cycles 6 weeks apart.

Evaluation will be done at week 52 and further at W76. The primary endpoint is the proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52. Secondary endpoints include the proportion of patients increasing their CD4 count over 50/mm3 between Week 00 and Week 24,and between Week 00 and Week 52, the occurrence of HIV-related events, drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with proven HIV-1-infection
  • Prior or current exposition to at least 1 molecule from each of the 3 antiretroviral classes (NRTI, NNRTI and PI)
  • In a situation of therapeutic failure on an ongoing regimen

Exclusion Criteria:

  • Patients included in the Macrolin® expanded French access program
  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: NCT00113282

Locations
France
Hôpital Necker service des Maladies Infectieuses
Paris, France, 75015
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Chiron Corporation
Investigators
Study Chair: Geneviève Chêne, Pr Inserm Unite 593
Principal Investigator: Jean Paul VIARD, Dr AP-HP
  More Information

No publications provided

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00113282     History of Changes
Other Study ID Numbers: 2004-001329-29, ANRS123
Study First Received: June 7, 2005
Last Updated: December 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Treatment failure
Acquired Immunodeficiency Syndrome
Interleukin-2
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014