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

NCT ID: NCT00002449

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Aldesleukin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiron Corporation

INDUSTRY

Sponsor Role: lead

Locations

Sorra Research Ctr / Med Forum

Birmingham, Alabama, United States

Pacific Oaks Research

Beverly Hills, California, United States

Orange County Ctr for Special Immunology

Fountain Valley, California, United States

St Lukes Medical Group

San Diego, California, United States

Kaiser Foundation Hospital

San Francisco, California, United States

Denver Inf Disease Consultants

Denver, Colorado, United States

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Community AIDS Resource Inc

Coral Gables, Florida, United States

Steinhart Medical Associates

Miami, Florida, United States

Specialty Med Care Ctrs of South Florida Inc

Miami, Florida, United States

AIDS Research Alliance - Chicago

Chicago, Illinois, United States

Northstar Med Clinic

Chicago, Illinois, United States

Fenway Community Health Ctr

Boston, Massachusetts, United States

North Jersey Community Research Initiative

Newark, New Jersey, United States

Albany Med College

Albany, New York, United States

Anderson Clinical Research Inc

Rego Park, New York, United States

Associates in Med and Mental Health

Tulsa, Oklahoma, United States

Research and Education Group

Portland, Oregon, United States

Anderson Clinical Research

Pittsburgh, Pennsylvania, United States

Central Texas Clinical Research

Austin, Texas, United States

N Texas Ctr for AIDS & Clin Rsch

Dallas, Texas, United States

Gathe, Joseph, M.D.

Houston, Texas, United States

Virginia Mason Med Ctr

Seattle, Washington, United States

Countries

United States

Other Identifiers

CS-MM-9901

Identifier Type: -

Identifier Source: secondary_id

B007

Identifier Type: -

Identifier Source: org_study_id