Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00002449
- Lead Sponsor
- Chiron Corporation
- Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.
- Detailed Description
This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 212
Not provided
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 (23)
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
St Lukes Medical Group
🇺🇸San Diego, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
Specialty Med Care Ctrs of South Florida Inc
🇺🇸Miami, Florida, United States
Fenway Community Health Ctr
🇺🇸Boston, Massachusetts, United States
Gathe, Joseph, M.D.
🇺🇸Houston, Texas, United States
Denver Inf Disease Consultants
🇺🇸Denver, Colorado, United States
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Albany Med College
🇺🇸Albany, New York, United States
Sorra Research Ctr / Med Forum
🇺🇸Birmingham, Alabama, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Research and Education Group
🇺🇸Portland, Oregon, United States
Virginia Mason Med Ctr
🇺🇸Seattle, Washington, United States
Anderson Clinical Research Inc
🇺🇸Rego Park, New York, United States
Community AIDS Resource Inc
🇺🇸Coral Gables, Florida, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
N Texas Ctr for AIDS & Clin Rsch
🇺🇸Dallas, Texas, United States