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

Chiron Corporation

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002107

CS-L293-09

085A

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.