CLINICAL TRIALS PROFILE FOR PROLEUKIN
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All Clinical Trials for PROLEUKIN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000825 ↗ | 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 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1998-05-01 | 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. |
| 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 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1997-10-01 | 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. |
| NCT00000909 ↗ | A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood. IL-2 (a protein found in the blood that helps boost the immune system) can result in increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection; however, some HIV patients do not wish to take antiretrovirals. This study asks if it is safe and effective to take IL-2 alone to treat HIV infection. |
| NCT00000948 ↗ | 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 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1998-02-01 | 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. |
| NCT00000949 ↗ | A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 1969-12-31 | The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV. There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden). |
| NCT00001357 ↗ | Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1993-08-01 | This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD. The anticipated accrual will be approximately 15 patients and the study will take one year to complete. Patients will receive Proleukin® (Registered Trademark) subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin® (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone. If tolerated, each patient will receive 3 cycles of therapy and, following completion of three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy. |
| NCT00002107 ↗ | A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients | Completed | Chiron Corporation | Phase 1 | 1969-12-31 | To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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