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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Chiron Corporation |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00113282 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Interleukin-2 (IL-2) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of the Immunological Efficacy of Adding Subcutaneous Interleukin-2 (IL-2) to an Optimized Antiretroviral Regimen in HIV-1-Infected Subjects Experiencing Therapeutic Failure on an Ongoing Antiretroviral Combination With a CD4 Cell Count ≤ 200/mm3 ANRS 123 Trial |
Enrollment: | 57 |
Study Start Date: | June 2004 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (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 and a high level of CD4 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 CD4 cell count is low is not known. The purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without IL-2.The choice of the antiretroviral regimen will be made from a genotype resistance test.
Ninety eight HIV-1-infected patients experiencing advanced treatment failure with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml, will be randomly assigned to one of two treatment groups: with or without IL-2.
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 8 cycles, ending at Week 42), the first two cycles 4 weeks apart, the following cycles 6 weeks apart.
Evaluation will be done at week 52 and further at W76. The primary endpoint is the proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52. Secondary endpoints include the proportion of patients increasing their CD4 count over 50/mm3 between Week 00 and Week 24,and between Week 00 and Week 52, 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:
Exclusion Criteria:
France | |
Hôpital Necker service des Maladies Infectieuses | |
Paris, France, 75015 |
Study Chair: | Geneviève Chêne, Pr | Inserm Unite 593 |
Principal Investigator: | Jean Paul VIARD, Dr | AP-HP |
Responsible Party: | ANRS ( MJ Commoy/ regulatory affairs sponsor ) |
Study ID Numbers: | 2004-001329-29, ANRS123 |
Study First Received: | June 7, 2005 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00113282 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Treatment failure Acquired Immunodeficiency Syndrome Interleukin-2 Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents |