Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:

1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation

The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:

1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation

• Drug: Maraviroc
  dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
  Other Names:

  • Selzentry
  • Celsentri
• Other: placebo
  subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
  Other Name: control

• Experimental: Maraviroc
  Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
  Intervention: Drug: Maraviroc
• Placebo Comparator: Placebo
  Subjects will receive 12 weeks of treatment with placebo
  Intervention: Other: placebo

Inclusion Criteria:

• obese (body mass index (BMI) between 30 and 45.9)
• increased plasma triglyceride concentrations (150-400 mg/dL)

Exclusion Criteria:

• active or previous infection with hepatitis B or C
• history of alcohol abuse
• current alcohol consumption (>20g/day)
• severe hypertriglyceridemia (>400 mg/dL)
• active peptic ulcer disease
• diabetes
• pregnant or lactating
• take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.