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

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: Human Immunodeficiency Virus (HIV) Infection

Treatments: Drug: Ritonavir; Drug: Maraviroc; Drug: Saquinavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717067

A4001075

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Healthy Subjects

Experimental group

Description:

Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Saquinavir

Drug: Maraviroc

Drug: Saquinavir

Drug: Saquinavir

Drug: Maraviroc

Drug: Ritonavir

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Ritonavir

Drug: Ritonavir

Mild Renal Impairment

Experimental group

Description:

Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min)

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Saquinavir

Drug: Maraviroc

Drug: Saquinavir

Drug: Saquinavir

Drug: Maraviroc

Drug: Ritonavir

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Ritonavir

Drug: Ritonavir

Moderate Renal Impairment

Experimental group

Description:

Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Saquinavir

Drug: Maraviroc

Drug: Saquinavir

Drug: Saquinavir

Drug: Maraviroc

Drug: Ritonavir

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Ritonavir

Drug: Ritonavir

Severe Renal Impairment

Experimental group

Description:

Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min)

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

ESRD on Hemodialysis

Experimental group

Description:

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

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc

Drug: Maraviroc