Interleukin-2 Therapy for HIV Infection - Supplemental Procedures

Inclusion Criteria

• •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.