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

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.

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.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin; Interleukin-2

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.