Conditions: Human Immunodeficiency Virus (HIV) Infection
Keywords: maraviroc, pharmacokinetics, renal impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.

Detailed description:

Arms:
arm 1: Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir arm 2: Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min) arm 3: Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min) arm 4: Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min) arm 5: 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

Interventions: intervention 1: Maraviroc intervention 2: Maraviroc intervention 3: Ritonavir intervention 4: Saquinavir intervention 5: Maraviroc intervention 6: Ritonavir intervention 7: Saquinavir intervention 8: Maraviroc intervention 9: Ritonavir intervention 10: Saquinavir intervention 11: Maraviroc intervention 12: Maraviroc intervention 13: Maraviroc
Intervention descriptions: intervention 1: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 2: Maraviroc 150 mg tablet twice daily x 7 days intervention 3: Ritonavir 100 mg capsule twice daily x 7 days intervention 4: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 5: Maraviroc 150 mg tablet once daily x 7 days intervention 6: Ritonavir 100 mg capsule twice daily x 7 days intervention 7: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 8: Maraviroc 150 mg tablet once every 48 hours x 7 days intervention 9: Ritonavir 100 mg capsule twice daily x 7 days intervention 10: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 11: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 12: Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis intervention 13: Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis

Protocol document: