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

NCT00717067 | Completed Phase 4 Results

• 1 other identifier: A4001075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

maraviroc, pharmacokinetics, renal impairment

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms \* hour divided by milliliters (ng\*hr/mL).

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

• AUCtau

  AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms \* hours divided by milliliters (ng.hr/mL).

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

• Maximum Observed Plasma Concentration (Cmax)

  Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

Secondary Outcomes (10)

• Plasma Protein Binding

  2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1

• Area Under the Time Curve From 0 to Infinity (AUCinf)

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72

• Time of First Occurrence (Tmax)

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

• Half-life (t1/2)

  Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

• Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function

  Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.

Study Arms (5)

Healthy Subjects

EXPERIMENTAL

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

Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir

Mild Renal Impairment

EXPERIMENTAL

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

Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir

Severe Renal Impairment

EXPERIMENTAL

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

Drug: Maraviroc

ESRD on Hemodialysis

EXPERIMENTAL

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

Drug: Maraviroc

Interventions

Ritonavir DRUG

Ritonavir 100 mg capsule twice daily x 7 days

Healthy Subjects

Saquinavir DRUG

Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days

Healthy Subjects

Maraviroc DRUG

Maraviroc 300 mg (150 mg x 2 tablets) x single dose

Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (2)

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

München, 81241, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Renal Insufficiency

Interventions

Maraviroc; Ritonavir; Saquinavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 19, 2010
• Results First Posted: December 21, 2009

Record last verified: 2010-11

Locations

DE (2)