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

Status unconfirmed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002449

Run by

Chiron Corporation

People needed

212

Starts

1999-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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