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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002107
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002107 on ClinicalTrials.gov Archive Site
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A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

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.

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

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Aldesleukin
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002107
085A, CS-L293-09
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Chiron Corporation
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NIH AIDS Clinical Trials Information Service
March 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP