A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Aldesleukin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chiron Corporation
Summary
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.
Clinical Details
Official title: A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Detailed description:
Patients will receive subcutaneous Proleukin, and the MTD will be determined.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- Documented HIV infection by ELISA and Western blot.
- CD4 count > 200 cells/mm3.
Required:
- FDA-approved antiretroviral therapy for at least 2 months prior to study entry.
Locations and Contacts
Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States
Additional Information
Related publications: 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)
Last updated: June 23, 2005
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