Back to resultsA Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Interleukin-2, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Eligibility 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.
Sites / Locations
- Davies Med Ctr / c/o HIV Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002107
Brief Title
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Official Title
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Chiron Corporation
4. Oversight
5. 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.
Detailed Description
Patients will receive subcutaneous Proleukin, and the MTD will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Interleukin-2, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
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A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
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