Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Interleukin-2 |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
- Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96
- 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
Estimated Enrollment: | 130 |
Study Start Date: | December 2003 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
France | |
Service des Maladies Infectieuses | |
Paris, France, 75010 |
Principal Investigator: | Jean-Michel Molina, MD | Hopital Saint Louis Paris service des Maladies infectieuses et Tropicales |
Study Chair: | Jean-Pierre Aboulker, MD | Inserm SC10 |
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00120185 History of Changes |
Other Study ID Numbers: | 2004-003897-27, ANRS119 Interstart |
Study First Received: | July 8, 2005 |
Last Updated: | December 21, 2011 |
Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV Infections Interleukin-2 |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on October 16, 2012