A Randomized Trial of Interleukin-2 Therapy in HIV-Infected Patients

Study start date: March 1, 1993

Patients must have documented HIV infection (ELISA and Western blot positive). Patients must be 18 years or older. Patients must have CD4 count greater than 200 cells/mm(3). Patients must have clinical laboratory values Grade 0 or 1. Patients must not have therapy with corticosteroids, chemotherapy, or experimental therapy in the prior 4 weeks. Patients must have a negative urine pregnancy test (women of childbearing potential). Patients with prior IL-2 therapy will be excluded. Patients with malignancy other than Kaposi sarcoma will be excluded. Patients with Kaposi sarcoma are eligible, but must not have received systemic therapy for KS within 4 weeks prior to study entry. Patients with history of prior AIDS-defining opportunistic infection will be excluded. Patients with active substance abuse which may affect patient safety or compliance will be excluded. Patients exhibiting psychiatric disturbance or illness, which in the assessment of the protocol team may affect patient safety or compliance will be excluded. Patients with significant cardiac, pulmonary, thyroid, kidney, rheumatologic, or CNS disease will be excluded. Patients with hypertension requiring anti-hypersensitive therapy will be excluded. Pregnant or lactating patients or patients of childbearing potential, will be excluded, unless they use effective contraception. Patients unwillingness to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV seropositivity and the risk of transmission of HIV infection will be cause for exclusion.