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| Descriptive Information Fields | |||||
| Brief Title † | 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 | ||||
| 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 | ||||
| Brief Summary | The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. 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. |
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| Detailed Description | Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased 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 this 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 receive antiretrovirals alone or antiretrovirals plus IL-2 given subcutaneously. Three doses of IL-2 are studied, with 12 patients evaluated at each dose. When at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicity, the next 12 patients are treated at the next highest dose every 12 hours for 5 days every 8 weeks; when this dose is tolerated, the last 12 patients randomized receive the highest study dose every 12 hours for 5 days every 8 weeks. Patients enrolled at the first two doses of IL-2 who complete three courses of treatment have their dose escalated to a maximum of the highest study dose. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study | ||||
| Primary Outcome Measure † | CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ] Laboratory and clinical adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | |||||
| Condition † | HIV Infections | ||||
| Intervention † | Drug: Aldesleukin Drug: ART |
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| MEDLINE PMIDs | |||||
| Links | Click here for more information about Aldesleukin ![]() Haga clic aquí para ver información sobre este ensayo clínico en español.  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 72 | ||||
| Start Date † | November 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Thailand | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000948 | ||||
| Organization ID | THAILAND | ||||
| Secondary IDs †† | IRP 021B | ||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | September 26, 2008 | ||||