A Phase I Study of Subcutaneously Administered Proleukin NCT00002107

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002107
Other study ID #	085A
Secondary ID	CS-L293-09
Status	Completed
Phase	Phase 1
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	March 1995
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

HIV Infections

Intervention

Drug:
• Aldesleukin

Locations
Country	Name	City	State
United States	Davies Med Ctr / c/o HIV Institute	San Francisco	California

Sponsors *(1)*
Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States,

References & Publications (1)

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)

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

Clinical Trial Details — Status: Completed

Administrative data

Study information