Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
Verified July 2001
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 2001
History of Changes
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.
Drug : Aldesleukin
Primary Purpose: Treatment
|Official Title:||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)|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||August 1999|
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.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002449
Locations Show More
|United States, Alabama|
|Sorra Research Ctr / Med Forum|
|Birmingham, Alabama, United States, 35203|
|United States, California|
|Pacific Oaks Research|
|Beverly Hills, California, United States, 90211|
|Orange County Ctr for Special Immunology|
|Fountain Valley, California, United States, 92708|
|St Lukes Medical Group|
|San Diego, California, United States, 92101|
|Kaiser Foundation Hospital|
|San Francisco, California, United States, 94118|
|United States, Colorado|
|Denver Inf Disease Consultants|
|Denver, Colorado, United States, 80220|
|United States, District of Columbia|
|Dupont Circle Physicians Group|
|Washington, District of Columbia, United States, 200091104|
|United States, Florida|
|Community AIDS Resource Inc|
|Coral Gables, Florida, United States, 33146|
|Steinhart Medical Associates|
|Miami, Florida, United States, 33133|
|Specialty Med Care Ctrs of South Florida Inc|
|Miami, Florida, United States, 33142|
|United States, Illinois|
|AIDS Research Alliance - Chicago|
|Chicago, Illinois, United States, 60657|
|Northstar Med Clinic|
|Chicago, Illinois, United States, 60657|
|United States, Massachusetts|
|Fenway Community Health Ctr|
|Boston, Massachusetts, United States, 02115|
|United States, New Jersey|
|North Jersey Community Research Initiative|
|Newark, New Jersey, United States, 071032842|
|United States, New York|
|Albany Med College|
|Albany, New York, United States, 12208|
|Anderson Clinical Research Inc|
|Rego Park, New York, United States, 11374|
|United States, Oklahoma|
|Associates in Med and Mental Health|
|Tulsa, Oklahoma, United States, 74114|
|United States, Oregon|
|Research and Education Group|
|Portland, Oregon, United States, 97210|
|United States, Pennsylvania|
|Anderson Clinical Research|
|Pittsburgh, Pennsylvania, United States, 15221|
|United States, Texas|
|Central Texas Clinical Research|
|Austin, Texas, United States, 78705|
|N Texas Ctr for AIDS & Clin Rsch|
|Dallas, Texas, United States, 75219|
|Gathe, Joseph, M.D.|
|Houston, Texas, United States, 77004|
|United States, Washington|
|Virginia Mason Med Ctr|
|Seattle, Washington, United States, 98101|
Sponsors and CollaboratorsChiron Corporation
|Responsible Party:||Chiron Corporation|
|ClinicalTrials.gov Identifier:||NCT00002449 History of Changes|
|Other Study ID Numbers:||B007|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Recombinant Proteins
Dose-Response Relationship, Drug
CD4 Lymphocyte Count
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.