Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

Exclusion Criteria

• •1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay
• •2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
• •3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
• •4. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
• •5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
• •6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose
• •7. Any vaccination within 2 weeks prior to the first study dose or during the study.
• •8. Subjects who have failed on a maraviroc containing regimen.
• •9. Subjects weighing \< 35kg
• •10. History of anaphylaxis to any oral or parenteral drugs
• •11. History of Bleeding Disorder or patients on anti-coagulant therapy
• •12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit
• •13. Any known allergy or antibodies to the study drug or excipients
• •14. Treatment with any of the following:
• •1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
• •2. Immunosuppressants within 60 days prior to the screening visit
• •3. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
• •4. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy \> 5 mg/day will be excluded with the following exception:
• •* Subjects on inhaled, nasal, or topical steroids will not be excluded
• •15. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy