Efficacy of Adding Interleukin-2 to an Optimized Antiretroviral Regimen in HIV Patients in Therapeutic Failure (ANRS123)
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
2 other identifiers
interventional
57
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Jun 2004
Typical duration for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 7, 2005
CompletedFirst Posted
Study publicly available on registry
June 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedApril 8, 2026
April 1, 2026
3.5 years
June 7, 2005
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52 (W52)
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients included in the Macrolin® expanded French access program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Necker service des Maladies Infectieuses
Paris, 75015, France
Related Publications (1)
Viard JP, Fagard C, Chaix ML, Rouzioux C, Bouteloup V, Bentata M, de Verdiere NC, Pahlavan G, Weiss L, Levy Y, Chene G; ANRS 123 ETOILE trial group. Immunological success is predicted by enfuvirtide but not interleukin-2 therapy in immunodepressed patients. AIDS. 2009 Jul 17;23(11):1383-8. doi: 10.1097/QAD.0b013e32832cdc26.
PMID: 19461505RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Geneviève Chêne, Pr
Inserm Unite 593
- PRINCIPAL INVESTIGATOR
Jean Paul VIARD, Dr
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2005
First Posted
June 8, 2005
Study Start
June 1, 2004
Primary Completion
December 1, 2007
Study Completion
February 1, 2008
Last Updated
April 8, 2026
Record last verified: 2026-04