- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000889
A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3
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
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires
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Ciudad de Buenos Aires, Buenos Aires, Argentina
- Hospital de Clinicas 'Jose de San Martin' C601-040 CRS
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Ciudad de Buenos Aires, Buenos Aires, Argentina
- Hospital F.J. Muniz C601-050 CRS
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Ciudad de Buenos Aires, Buenos Aires, Argentina
- Hospital General de Agudos J.M. Ramos Mejia CPCRA CRS
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Ciudad de Buenos Aires, Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires C601-020 CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 cell count greater than or equal to 300 cells/mm3.
- Are at least 18.
- Have been on antiretroviral therapy for at least 7 days prior to study entry.
Exclusion Criteria
You will not be eligible for this study if you:
- Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study.
- Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system (CNS) abnormality, or an autoimmune/inflammatory disease.
- Are pregnant or breast-feeding.
- Have ever received IL-2.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: M Losso
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Aldesleukin
Other Study ID Numbers
- IRP 021A
- 10467 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- SQ 1 ARG
- SQIL-2 Argentina
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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