CompletedPhase 2

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

France57 participantsStarted 2004-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52 (W52)

Trial details

NCT IDNCT00113282

SponsorFrench National Agency for Research on AIDS and Viral Hepatitis

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2007-12

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