Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV positivity.
• • CD4 count \>= 500 cells/mm3.
• • No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.
• Concurrent Medication: Required:
• • Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).
• Prior Medication: Required:
• • FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Significant cardiac, pulmonary, thyroid, renal, or CNS disease.
• Prior Medication:
• Excluded:
• • Prior IL-2.
• • Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.