NCT00717067

Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

An Open-Label, Parallel Group, Single And Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Human Immunodeficiency Virus (HIV) Infection

Interventions

Type	Name	Description
DRUG	Maraviroc	Maraviroc 300 mg (150 mg x 2 tablets) x single dose
DRUG	Maraviroc	Maraviroc 150 mg tablet twice daily x 7 days
DRUG	Ritonavir	Ritonavir 100 mg capsule twice daily x 7 days
DRUG	Saquinavir	Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
DRUG	Maraviroc	Maraviroc 150 mg tablet once daily x 7 days
DRUG	Ritonavir	Ritonavir 100 mg capsule twice daily x 7 days
DRUG	Saquinavir	Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
DRUG	Maraviroc	Maraviroc 150 mg tablet once every 48 hours x 7 days
DRUG	Ritonavir	Ritonavir 100 mg capsule twice daily x 7 days
DRUG	Saquinavir	Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
DRUG	Maraviroc	Maraviroc 300 mg (150 mg x 2 tablets) x single dose
DRUG	Maraviroc	Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis
DRUG	Maraviroc	Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-07-16
• Last updated: 2010-11-19
• Results posted: 2009-12-21

Locations

2 sites across 1 country: Germany