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

• Sponsor: Chiron Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00002107
• Collaborator: (none)
• Location: 1

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
HIV Infections	Drug: Aldesleukin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Official Title: A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 0 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Davies Med Ctr / c/o HIV Institute	San Francisco	California	United States	94114

Sponsors and Collaborators

• Chiron Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

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)

• ClinicalTrials.gov Identifier: NCT00002107
• Other Study ID Numbers: 085A; CS-L293-09
• First Posted: Aug 31, 2001
• Last Update Posted: Jun 24, 2005
• Last Verified: Mar 1, 1995

• Keywords provided by , ,: Interleukin-2; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
• Additional relevant MeSH terms: HIV Infections; Aldesleukin

Study Results

No Results Posted as of Jun 24, 2005