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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiron Corporation
• Treatments: Aldesleukin; Interleukin-2

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.