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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Maraviroc; Ritonavir; Saquinavir

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.