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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 (IL-2) in Antiretroviral Naïve HIV-1-Infected Subjects With a CD4 Cell Count Above 300/mm3. ANRS 119 Trial INTERSTART

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Interleukin-2


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interleukin-2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96 |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Infections, Interleukin-2