Interleukin-2 Therapy for HIV Infection - Supplemental Procedures

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

This study is designed as a randomized, open label trial to evaluate the effect of interleukin-2 (IL-2) on CD4 counts in patients with HIV infection and CD4 counts above 200 cells/mm(3). 60 patients will receive either antiretroviral therapy or antiretroviral therapy plus IL-2 administered by continuous infusion at a dose of 18 million international units (IU)/day for 5 days every two months for 1 year. Patients will be seen at the NIH every 4 weeks, at which time immune parameters, including CD4 number and percent, will be determined.

Gender

ALL

Eligibility 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.