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

Launched by CHIRON CORPORATION · Aug 30, 2001

Keywords

ClinConnect Summary

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...

Gender

ALL

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.