Daclizumab to Treat HIV-Infected Patients

Exclusion Criteria

• •1. Patients who are pregnant or who are nursing infants will not be eligible. Women of child-bearing potential must have a negative pregnancy test on the day of study entry.
• •2. Acute or chronic liver disease, history of alcohol abuse or drug abuse that would interfere with participation in the clinical trial.
• •3. History of any malignant neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
• •4. History of bladder cancer.
• •5. Previous treatment with daclizumab.
• •6. Inability to comply with study guidelines.
• •7. Hemocytopenia: platelet count less than 80,000/mm(3), absolute neutrophil count less than 1500/mm(3), hematocrit less than 30% (in the absence of gastrointestinal bleeding or hemolytic anemia).
• •8. ALT/AST greater than 5 times the upper limit of normal, PT INR greater than 2 times the upper limit of normal, creatinine greater than 1.5 times the upper limit of normal.
• •9. Concurrent use of any other immunosuppressive therapy including systemic steroids for a duration of six weeks or more six months prior to enrollment.
• •10. History of use of the immunomodulatory agent such as IL-2 or interferon within the last 5 years.
• •11. Known allergy to murine proteins.
• •12. Medical illness that in the opinion of the investigator might confound results or interfere with the subject's ability to participate in the trial.