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

Phase 2 Completed 57 enrolled French National Agency for Research on AIDS and Viral Hepatitis Chiron Corporation · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2004-06
Primary completion: 2007-12
Completion: 2008-02

Outcome

Missed primary endpoint

paper were not significantly different. PMID 19461505 ↗

paper IL-2 failed to increase CD4 cell count in immunocompromised patients with multiple therapeutic failures. PMID 19461505 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	aldesleukin	Protein / enzyme biologic	4.5 iu	Subcutaneous