Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected With HIV With CD4+ T-Cell Counts of 300 to 500 Cells/mm3 and Viral Burden Under 10,000 Copies/Ml on Active Antiretroviral Therapy (ART)
2 other identifiers
interventional
212
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load below 10,000 copies/ml.
- Have a CD4 count between 300 and 500 cells/mm3.
- Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI).
- Are at least 18 years old.
- Agree to use an effective barrier method of birth control, such as condoms, during the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.)
- Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate.
- Have cancer requiring chemotherapy.
- Have a history of autoimmune disease.
- Have uncontrolled diabetes or certain thyroid problems.
- Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate.
- Have received IL-2 in the past.
- Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks.
- Have taken hydroxyurea in the past 4 months.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203, United States
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
St Lukes Medical Group
San Diego, California, 92101, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Denver Inf Disease Consultants
Denver, Colorado, 80220, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
Community AIDS Resource Inc
Coral Gables, Florida, 33146, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Albany Med College
Albany, New York, 12208, United States
Anderson Clinical Research Inc
Rego Park, New York, 11374, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Research and Education Group
Portland, Oregon, 97210, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Gathe, Joseph, M.D.
Houston, Texas, 77004, United States
Virginia Mason Med Ctr
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
August 1, 1999
Last Updated
June 24, 2005
Record last verified: 2001-07