Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects

Exclusion Criteria

• •Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
• •Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
• •Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
• •Treatment for an active opportunistic infection, or unexplained temperature \>38.5 degrees Celsius for 7 consecutive days
• •Active alcohol or substance abuse sufficient, in the Investigator's judgement, to prevent adherence to study medication and/or follow up
• •Lactating women, or planned pregnancy during the trial period
• •Significant renal insufficiency
• •Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period
• •Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
• •Significantly elevated liver enzymes or cirrhosis
• •Significant neutropenia, anemia or thrombocytopenia
• •Malabsorption or an inability to tolerate oral medications
• •Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease
• •Certain medications
• •Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
• •X4- or dual/mixed-tropic virus or repeated assay failure
• •Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy