Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist

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

Keywords

ClinConnect Summary

In the initial phase of this study, HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks, IL-2 plus anti-TNF antibody, or IL-2 plus thalidomide. The primary endpoints of this study are safety and tolerability of the IL-2/TNF inhibitor combination. Secondary endpoints will include changes in CD4 counts, frequency and severity of IL-2 related side effects, changes in serum TNF levels, and plasma viral load changes. The study period is one year, with an optional extension period to follow. Enro...

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Eligibility criteria

• 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.