A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1995
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.
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Patients will receive subcutaneous Proleukin, and the MTD will be determined.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients must have:
- Documented HIV infection by ELISA and Western blot.
- CD4 count > 200 cells/mm3.
- FDA-approved antiretroviral therapy for at least 2 months prior to study entry.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002107
|Davies Med Ctr / c/o HIV Institute
|San Francisco, California, United States, 94114 |
Follansbee SE, Lacarrubba S, Fyfe G. Dose-ranging study of interleukin II (IL-2) in HIV-infected men on antiretroviral therapy (ARV). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 419)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015