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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Aldesleukin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chiron Corporation


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Detailed description: Patients will receive subcutaneous Proleukin, and the MTD will be determined.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria 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.

Locations and Contacts

Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States
Additional Information

Related publications:

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)

Last updated: June 23, 2005

Page last updated: August 23, 2015

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