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

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

This study has been completed.

Sponsored by:	Chiron Corporation
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002107

Purpose

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	Intervention	Phase
HIV Infections	Drug: Aldesleukin	Phase I

MedlinePlus related topics:

AIDS

Drug Information available for:

Aldesleukin Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002107

Locations


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

Sponsors and Collaborators

Chiron Corporation

More Information

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)

Study ID Numbers:	085A, CS-L293-09
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002107
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Interleukin-2

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Aldesleukin

Interleukin-2

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Anti-Retroviral Agents

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008