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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002107

Run by

Chiron Corporation

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States

Full record on ClinicalTrials.gov

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