Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy - Full Text View

Sponsor:	Chiron Corporation
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002449

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Aldesleukin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study
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)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Interleukin-2 Aldesleukin

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	212
Study Start Date:	August 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002449

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Locations

United States, Alabama
Sorra Research Ctr / Med Forum
Birmingham, Alabama, United States, 35203
United States, California
St Lukes Medical Group
San Diego, California, United States, 92101
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
Pacific Oaks Research
Beverly Hills, California, United States, 90211
Orange County Ctr for Special Immunology
Fountain Valley, California, United States, 92708
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
Steinhart Medical Associates
Miami, Florida, United States, 33133
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States, 33142
Community AIDS Resource Inc
Coral Gables, Florida, United States, 33146
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
Gathe, Joseph, M.D.
Houston, Texas, United States, 77004
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States, 75219
Central Texas Clinical Research
Austin, Texas, United States, 78705
United States, Washington
Virginia Mason Med Ctr
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Chiron Corporation

More Information

No publications provided

Study ID Numbers:	B007, CS-MM-9901
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002449 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Injections, Subcutaneous
Interleukin-2
Dose-Response Relationship, Drug

CD4 Lymphocyte Count
Anti-HIV Agents
Viral Load
Pharmacokinetics

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Retroviridae Infections
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases

Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Aldesleukin
HIV Infections
Interleukin-2
Analgesics, Non-Narcotic
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009