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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000821

IL-2 SC

IRP 015

93-I-0205

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.