Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated
dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose
less than MTD. The anticipated accrual will be approximately 15 patients and the study will
take one year to complete. Patients will receive Proleukin® (Registered Trademark)
subcutaneously at their assigned dose level once per day for 5 days approximately every eight
weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin®
(Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone.
If tolerated, each patient will receive 3 cycles of therapy and, following completion of
three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by
study personnel on an outpatient basis for at least the first cycle of therapy.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)