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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000948 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Aldesleukin Drug: ART |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, 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 |
| Enrollment: | 72 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will be broken into 3 groups. Each group will receive ART and escalating doses of aldesleukin. All participants will then receive that maximum tolerated dose of aldesleukin.
|
Drug: Aldesleukin
Il-2
Drug: ART
antiretroviral therapy for the treatment of HIV
|
|
2: Active Comparator
All participants will receive ART
|
Drug: ART
antiretroviral therapy for the treatment of HIV
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | THAILAND, IRP 021B |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000948 History of Changes |
| Health Authority: | United States: Federal Government |
|
Injections, Subcutaneous Interleukin-2 Dose-Response Relationship, Drug |
Drug Therapy, Combination CD4 Lymphocyte Count Anti-HIV Agents |
|
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 |
