Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*

Exclusion Criteria

• •Current opportunistic infection characteristic of AIDS
• •Patients unable or unwilling to comply with the dosing schedule and protocol evaluations.
• •Patients with malabsorption syndromes affecting drug absorption.
• •Patients with systolic blood pressure \< 90 mmHg or \> 140 mmHg or diastolic blood pressure \< 60 mmHg or \> 90 mmHg measured in a semi-recumbent position after at least 10 minutes of rest at the screening or qualification visit.
• •A history of seizures (excluding pediatric febrile seizures), migraines, cluster and/or chronic headaches, cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
• •Patients with abnormal Hemoglobin (\< 10.0 g/dL for men and \< 9.0 g/dL for women), Neutrophil count (\< 1000/mm3), Platelet count (\< 100,000/mm3), AST or ALT \> 2.5 times the upper limit of normal (patients with a positive HBV surface antigen or HCV antibody test at screening must have AST and ALT no more than 1.5 times the upper limit of normal)
• •Patients who have received radiation therapy or cytotoxic chemotherapeutic agents, immunomodulating agents, HIV immunotherapeutic vaccine, an investigational drug or product, or participation in a drug study within 4 weeks prior to the first dose of study drug.
• •A history of alcoholism or drug addiction within the past 1 year (unless enrolled in a treatment program and approved by the sponsor). Recent use of any recreational drugs (except marijuana).
• •A history of difficulty donating blood or inadequate venous access.
• •The donation of blood or plasma within 30 days prior to receiving study medication.
• •Note: patients with a CD4 count \<100 cells/mm3 will be considered for enrollment following discussion and agreement between the Investigator and the Sponsor.