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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000889 |
To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone.
IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Randomized, Open-Label, Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3 |
Estimated Enrollment: | 78 |
Study Completion Date: | August 2007 |
Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in increases in CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with the combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.
Patients are randomized to control therapy with antiretrovirals alone (36 patients) or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks. Three doses of IL-2 are studied, with 12 patients evaluated at each dose.
If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities, the next 12 patients randomized are treated with the next higher dose; if this dose is tolerated, the last 12 patients randomized receive the highest study dose. Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Argentina | |
FUNCEI | |
Buenos Aires, Argentina | |
Hosp Muniz | |
Buenos Aires, Argentina | |
Hosp Fernandez | |
Buenos Aires, Argentina | |
Hosp Ramos Mejias | |
Buenos Aires, Argentina | |
Hosp de Clinicas | |
Buenos Aires, Argentina | |
Hosp Italiano | |
Buenos Aires, Argentina |
Study Chair: | M Losso |
Study ID Numbers: | SQ 1 ARG, IRP 021A, SQIL-2 Argentina |
Study First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00000889 |
Health Authority: | United States: Federal Government |
Interleukin-2 CD4 Lymphocyte Count Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Aldesleukin HIV Seropositivity Interleukin-2 |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Antiviral Agents |
Pharmacologic Actions Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents |