A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
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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.
Condition or disease
Patients will receive subcutaneous Proleukin, and the MTD will be determined.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Documented HIV infection by ELISA and Western blot.
CD4 count > 200 cells/mm3.
FDA-approved antiretroviral therapy for at least 2 months prior to study entry.
Follansbee SE, Lacarrubba S, Fyfe G. Dose-ranging study of interleukin II (IL-2) in HIV-infected men on antiretroviral therapy (ARV). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 419)