Status:
COMPLETED
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
Human Immunodeficiency Virus (HIV) Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00717067
Start Date
July 1 2008
End Date
November 1 2008
Last Update
November 19 2010
Active Locations (2)
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1
Pfizer Investigational Site
Berlin, Germany, 10117
2
Pfizer Investigational Site
München, Germany, 81241