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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Aldesleukin

U.S. FDA Resources

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
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002107 History of Changes
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:

Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes
Virus Diseases

Aldesleukin
Anti-Retroviral Agents
HIV Infections
Interleukin-2
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Aldesleukin
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009