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

NCT00113282

CompletedPhase 2

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infections

Interventions: Interleukin-2 (IL-2)

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Paris, France