Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Human Immunodeficiency Virus (HIV) Infection
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) Infection focused on measuring maraviroc, pharmacokinetics, renal impairment
Eligibility Criteria
Inclusion Criteria:
- Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks.
- Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.
- Total body weight >50 kg (110 lbs).
- Male or female subjects between the ages of 18 and 85 years.
Exclusion Criteria:
- Subjects with acute renal disease and/or history of renal transplant.
- Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.
- Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Healthy Subjects
Mild Renal Impairment
Moderate Renal Impairment
Severe Renal Impairment
ESRD on Hemodialysis
Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir
Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance <30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis