The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers

Inclusion Criteria:

• Caucasian males
• healthy individuals based on history/physical examination and laboratory evaluations (no out-of-range results from hematology tests (hemoglobin (Hb) > 130 g/L in men; absolute neutrophil count (ANC) > 2000 cells/uL; platelets > 159 x 109/L), biochemistry (AST < 35 IU/L, ALT < 40, IU/L, alkaline phosphatase < 100 IU/L, total bilirubin < 17 umol/L, lipase < 45 IU/L, creatinine < 120 umol/L, normal coagulation tests (INR < 1.2, aPPT < 40 seconds) and urinalysis.
• LDL-cholesterol </= 5 mmol/L, triglycerides </= 1.7 mmol/L and a 10 year estimate of cardiovascular (CV) disease risk of </= 10% ("low risk") as per the Framingham risk score modified for family history (doubling of CV risk if any CV disease in a first-degree relative before 60 years of age); the modified Framingham risk score takes into account age, HDL-cholesterol, total cholesterol, systolic blood pressure, smoker status, presence of diabetes and family history of CV disease
• normal 12-lead electrocardiogram
• systolic blood pressure between 105 and 130 mmHg
• diastolic blood pressure between 60 and 90 mmHg
• supine heart rate between 60 and 100 beats per minutes
• no evidence of HIV infection (ELISA test and Western Blot), no evidence of hepatitis B virus infection (HBsAg negative and anti-HBcAg negative or HBsAg negative with positive anti-HBsAg and positive anti-HBcAg) or HCV infection at screening (anti-HCV serology)
• using an effective barrier method of contraception
• non-smoker
• drinking less than 14 units of alcohol per week with a maximum of 4 units per day where one unit of alcohol corresponds to 341 mL of standard beer or 142 mL of wine or 43 ml of spirits
• negative illicit drug test at screening;
• with a body mass index between 18.0 to 30.0 kg/m2
• aged from 18 to 50 years old
• volunteers must be able to understand and comply with the protocol requirements and willing to sign the informed consent form prior to any study procedure;
• absence of exclusion criteria.

Exclusion Criteria:

• history of postural hypotension
• cardiac disease
• acute or chronic liver disease or any hepatic impairment
• acute or chronic kidney disease or any renal impairment
• use of prescription drugs, over the counter drugs, recreational drugs, herbal or dietary supplements including vitamins and grapefruit juice within 15 days of study initiation (day 1) except for acetaminophen and/or ibuprofen on an as needed basis. These products will also be prohibited during the study (except for as needed acetaminophen and/or ibuprofen)
• subjects who received any experimental medication within the last 2 months and/or donated blood during the previous 2 months or intends to donate blood within 2 months following completion of the study will also be excluded;
• subjects who had unprotected sexual activities during the last 6 months with a new or recent partner
• subjects who injected intravenous drugs over the last 6 months
• subjects with a social condition, psychological or addictive disorder that would impair protocol adherence.