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

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

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

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• ViiV Healthcare

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2008-11-30

Completion

2008-11-30

Countries

• Germany

Study Locations