A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002107
- Lead Sponsor
- Chiron Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States