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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Study Identification, Study Status, Referencesv13
  2. 2 versions Re-verified since Jun 10, 2009, no change to tracked fieldsv11-v12
  3. Study title expanded, about 1 wordv10
  4. Study completion date: Dec 2007 to Feb 2008v9
  5. Enrollment target: 98 to 57
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 22 words
    v8
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  1. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Dec 2007
    v7
  2. Study completion date: Dec 2007v6
  3. Collaborators expanded, about 2 wordsv5
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  5. 2 versions Re-verified since Jun 30, 2005, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT00113282
Lead Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Collaborators: Chiron Corporation
Conditions
(from sponsor)		 HIV Infections
Related terms Acquired Immunodeficiency Syndrome, HIV Infections
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov