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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiron Corporation
• Treatments: Aldesleukin; Interleukin-2

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.