drugset / Trial / NCT00002107

A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

NCT00002107

Phase 1 Completed Chiron Corporation
Treatment

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.

Timeline

Start
Primary completion
Completion

Publications

  • Background 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)

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic Subcutaneous