Common Variable Immunodeficiency
Conditions
Keywords
common variable immunodeficiency, immunologic disorders and infectious disorders, primary immunodeficiency disease, rare disease
Brief summary
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
Detailed description
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo. Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months. Patients are followed every 4 months for 2 years. Completion date provided represents the completion date of the grant per OOPD records
Interventions
DRUGPEG-interleukin-2
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures --Prior/Concurrent Therapy-- No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day) Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required --Patient Characteristics-- Life expectancy: At least 24 months Other: Not pregnant or nursing HIV negative
Outcome results
None listed