Safety and Tolerability of Repeat Courses of IM Alefacept

Exclusion Criteria

• •1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
• •2. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
• •3. Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
• •4. Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
• •5. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
• •6. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
• •7. Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
• •8. Known HIV+, known viral Hepatitis infection, known tuberculosis infection.