Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

HIV Infection

Clinical Trial Details

NCT number	NCT00001357
Study type	Interventional
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	Phase 2
Start date	August 1993
Completion date	April 2002

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