Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00120185
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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.

Detailed Description

IL-2 is produced naturally in the body and helps CD4 cells multiply. In earlier studies in HIV-infection, most of the patients with a controlled viral load under antiretroviral therapy and a high level of CD4 cell count (over 200/mm3) who received IL-2, experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone. The efficacy of IL-2 when the viral load is high and the patient is not receiving antiretroviral therapy is not known. The purpose of this multicentric national study is to compare the effects of IL-2 versus no treatment in HIV naïve patients. One hundred thirty HIV-1-infected patients, with a CD4 count between 300 and 500/mm3, will be randomly assigned to one of two treatment groups : IL-2 or no treatment. The group with IL-2 will receive a dose of 4.5 million international units by subcutaneous injection twice a day for 5 days (up to a total of 5 cycles, ending at Week 96), the first three cycles 8 weeks apart. Evaluation will be done at week 96. The primary endpoint is the proportion of patients reaching an absolute CD4 count below 300/mm3 at Week 96. Secondary endpoints include the occurrence of HIV-related events, drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-07-08
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-15
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Adult patients with proven HIV-1-infection
• No prior exposition to antiretrovirals
• CD4 cell count between 300 and 500/mm3
• Signed written inform consent

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Exclusion Criteria

• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96

Secondary Outcome Measures

Name	Time	Method
Quality of life at W96
Assessment of lipodystrophy at W96
Tolerance of IL-2
Evolution of the HIV DNA level in PBMCs
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
Evolution of the plasma HIV RNA load
Immunological substudies (CD4 homeostasis, anti HIV cellular immune responses) at W96

Trial Locations

Locations (1)

Service des Maladies Infectieuses; 🇫🇷 Paris, France