A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection

Study start date: June 1, 1995

IL-2 NAIVE PATIENTS: Documented HIV-1 infection (ELISA and Western blot positive). 18 years or older. CD4 count greater than or equal to 200 cells per mm(3) and less than or equal to 500 cells/mm(3) Clinical laboratory values Grade 0 or 1. No therapy with corticosteroids, chemotherapy, pentoxifylline, thalidomide, or experimental therapy in the prior 4 weeks. Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential). Current treatment with a stable regimen or licensed anti-retroviral therapy for at least 2 weeks. Adequate venous access in the upper extremities for repeated blood drawing and intravenous catheter placement. No prior IL-2 therapy. No malignancy other than Kaposi's sarcoma. Patients with Kaposi's sarcoma are eligible, but most not have received systemic therapy for KS within 4 weeks prior to study entry. No history of prior AIDS-defining opportunistic infection other than pulmonary TB or recurrent pneumonia. No active substance abuse which may affect patient safety or compliance. No patients exhibiting psychiatric disturbance or illness which in the assessment of the protocol team may affect patient safety or compliance. No patients with significant cardiac, pulmonary, rheumatologic, thyroid, kidney, gastrointestinal or neurological disease that could either decrease absorption of oral therapy, prove a cardiovascular risk during the fluid shifts and stresses that occur with IL-2 therapy, or that could have an inflammatory/immune etiology and thus might be activated or worsened by IL-2. No patients with hypertension requiring continuous anti-hypertensive therapy. No pregnant or lactating patients. Women of childbearing potential must agree to practice abstinence or use 2 forms of contraception simultaneously beginning 1 month prior to receiving study medication and continuing thereafter until 1 month after the last dose of study medication. Men must agree to practice abstinence or use a condom when engaging in intercourse during the same time period. Must be willing 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-1 seropositivity and the risk of transmission of HIV-1 infection. No history of hypersensitivity or intolerance to either IL-2 or thalidomide. PRIOR IL-2 THERAPY PATIENTS: Active participation in protocols 91-CC-0113 or 93-CC-0143. Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential). No history of hypersensitivity or intolerance to thalidomide.