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
2 other identifiers
interventional
130
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Dec 2003
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
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 8, 2005
CompletedFirst Posted
Study publicly available on registry
July 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedDecember 22, 2011
December 1, 2011
2.9 years
July 8, 2005
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients with proven HIV-1-infection
- No prior exposition to antiretrovirals
- CD4 cell count between 300 and 500/mm3
- Signed written inform consent
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service des Maladies Infectieuses
Paris, 75010, France
Related Publications (1)
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 Hepatites 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. doi: 10.1086/599989.
PMID: 19508157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel Molina, MD
Hopital Saint Louis Paris service des Maladies infectieuses et Tropicales
- STUDY CHAIR
Jean-Pierre Aboulker, MD
Inserm SC10
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
July 8, 2005
First Posted
July 15, 2005
Study Start
December 1, 2003
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
December 22, 2011
Record last verified: 2011-12