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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Chiron Corporation |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00004978 |
The purpose of this study is to see if it is effective to give HIV positive patients interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a period of 5 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients rIL-2 plus anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. IL-2 is a protein found naturally in the blood that helps boost the immune system.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Aldesleukin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 (Proleukin) in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3: Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) |
Estimated Enrollment: | 4241 |
Study Start Date: | March 2000 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1 will receive SC rIL-2 therapy
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Drug: Aldesleukin
Recombinant interleukin-2
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2: No Intervention |
Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication. However, these drug combinations do not result in viral eradication and, for many patients, virologic and immunologic control cannot be maintained. Even among patients with apparent virologic control, a "ceiling effect" seems to exist with failure of CD4 cell counts to rise on average more than 100 to 150 cells/mm3, at least during the first 2 years of therapy. The incomplete recovery of immune function after initiation of therapy remains an obstacle in the management of HIV. Preservation of immune function by direct expansion of CD4 lymphocytes with IL-2 could represent a significant additional treatment strategy. It also has been speculated recently that IL-2 in combination with potent antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. It is hoped that intervention with rIL-2 therapy in combination with antiretroviral therapy at an early stage of HIV infection can prevent CD4 T-cell depletion and result in fewer AIDS-defining illnesses than with antiretroviral therapy alone.
Patients are randomized to receive SC rIL-2 therapy or no SC rIL-2 therapy. All patients must receive combination antiretroviral treatment, with the choice of therapy at the discretion of the treating clinician. However, antiretroviral medications are not provided by this study. Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop. After the first three cycles, additional cycles are given at the discretion of each patient's physician, with a general goal of maintaining the patient's CD4 cell count at twice the baseline level or at 1,000 cells/mm3 or above for as long as possible. Patients in the no SC rIL-2 group receive no injections. Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts. All patients are followed for an average of 5 years. During the trial, patients in the no SC rIL-2 group are not given rIL-2 at any point.
However, at the end of the study, if rIL-2 is found to be effective in reducing the rate of disease progression [AS PER AMENDMENT 12/15/00: (new and recurrent events)], including death, all patients are offered rIL-2.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Donald Abrams, MD | University of California, San Francisco |
Study Chair: | David Cooper, MD, DSc | National Centre for HIV Epidemiology and Clinical Research |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ESPRIT 001, 00 I-0071, 3-U01-AI046957-05S2, 3-U01-AI046957-05S3 |
Study First Received: | March 10, 2000 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00004978 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Recombinant Proteins Injections, Subcutaneous HIV-1 Interleukin-2 Drug Therapy, Combination |
CD4 Lymphocyte Count Disease Progression Follow-Up Studies Anti-HIV Agents |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Disease Progression Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases Aldesleukin |
Anti-Retroviral Agents HIV Seropositivity Analgesics, Non-Narcotic HIV Infections Interleukin-2 Sexually Transmitted Diseases Peripheral Nervous System Agents Analgesics Retroviridae Infections |
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Retroviridae Infections RNA Virus Infections Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Aldesleukin HIV Infections Interleukin-2 Analgesics, Non-Narcotic Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |