Nelfinavir in Systemic Lupus Erythematosus

Inclusion Criteria

• •1. Subject is capable of providing written informed consent
• •2. Subject is ≥ 18 years old and ≤ 65 years old
• •3. Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of Systemic Lupus Erythematosus
• •4. Has mild to moderate disease activity defined as
• •* A minimum SLEDAI score of 2 excluding points for serology (anti-dsDNA antibody and complement)
• •* No active renal or nervous system disease
• •* No BILAG A in any organ system
• •* No expectation by the investigator that corticosteroids will need to be added or doses increased during the 8 week treatment period for any reason
• •* No expectation by the investigator that immunosuppressive medication will need to be added or doses increased during the 8 week treatment period
• •5. Has elevated titers of anti-ds DNA antibody at the time of screening (defined as the titer that meets criteria for "high" in the Core Laboratory at the North Shore/LIJ Health Systems; unequivocal high titer as opposed to borderline, indeterminate or intermediate).
• •6. Has elevated titers of cross-reactive anti-DNA/DWEYS antibodies at the time of screening (the assays for anti-DNA/DWEYS antibodies will be performed in Dr. B. Diamond's laboratory; study sites will be notified of results within 3 days of receipt of the samples).
• •7. If on glucocorticoids, the dose must be ≤10 mg daily and stable for the 4 weeks prior to screening and baseline
• •8. If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must have been stable for the 3 months prior to screening, and expected to remain stable over the course of the study.
• •9. Males and females with potential for reproduction must agree to practice effective birth control measures (2 approved methods of contraception). Nelfinavir can decrease serum levels of oral contraceptives; the slightly increased risk of pregnancy due to an interaction between oral contraception and nelfinavir will be discussed when appropriate and the requirement for a second approved method of contraception will be addressed.