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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120185
• Other study ID #: 2004-003897-27
• Secondary ID: ANRS119 Intersta
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2005
• Last updated: December 21, 2011
• Start date: December 2003
• Est. completion date: November 2006

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Interleukin-2

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Chiron Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96
Secondary	Group B or C events (1993 CDC classification of HIV infection)
Secondary	Initiation of antiretroviral therapy
Secondary	Evolution of the CD4 count during the study
Secondary	Time to the first visit with a CD4 count below 300/mm3
Secondary	Tolerance of IL-2
Secondary	Evolution of the plasma HIV RNA load
Secondary	Evolution of the HIV DNA level in PBMCs
Secondary	Quality of life at W96
Secondary	Assessment of lipodystrophy at W96
Secondary	Immunological substudies (CD4 homeostasis, anti HIV cellular immune responses) at W96