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

Chiron Corporation

Overview

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.

Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

HIV Infections

Interventions

AldesleukinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Davies Med Ctr / c/o HIV Institute

San Francisco, California, United States

Data from ClinicalTrials.gov

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