---
title: Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
nct_id: NCT00717067
overall_status: COMPLETED
phase: PHASE4
sponsor: ViiV Healthcare
study_type: INTERVENTIONAL
primary_condition: Human Immunodeficiency Virus (HIV) Infection
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00717067.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00717067"
ct_last_update_post_date: 2010-11-19
last_seen_at: "2026-05-12T07:19:08.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

**Official Title:** An Open-Label, Parallel Group, Single And Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

**NCT ID:** [NCT00717067](https://clinicaltrials.gov/study/NCT00717067)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** ViiV Healthcare
- **Collaborators:** Pfizer
- **Conditions:** Human Immunodeficiency Virus (HIV) Infection
- **Start Date:** 2008-07
- **Completion Date:** 2008-11
- **CT.gov Last Update:** 2010-11-19

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Healthy Subjects** (EXPERIMENTAL) — Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir
- **Mild Renal Impairment** (EXPERIMENTAL) — Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min)
- **Moderate Renal Impairment** (EXPERIMENTAL) — Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
- **Severe Renal Impairment** (EXPERIMENTAL) — Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min)
- **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

## Interventions

- **Maraviroc** (DRUG) — Maraviroc 300 mg (150 mg x 2 tablets) x single dose
- **Maraviroc** (DRUG) — Maraviroc 150 mg tablet twice daily x 7 days
- **Ritonavir** (DRUG) — Ritonavir 100 mg capsule twice daily x 7 days
- **Saquinavir** (DRUG) — Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
- **Maraviroc** (DRUG) — Maraviroc 150 mg tablet once daily x 7 days
- **Ritonavir** (DRUG) — Ritonavir 100 mg capsule twice daily x 7 days
- **Saquinavir** (DRUG) — Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
- **Maraviroc** (DRUG) — Maraviroc 150 mg tablet once every 48 hours x 7 days
- **Ritonavir** (DRUG) — Ritonavir 100 mg capsule twice daily x 7 days
- **Saquinavir** (DRUG) — Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
- **Maraviroc** (DRUG) — Maraviroc 300 mg (150 mg x 2 tablets) x single dose
- **Maraviroc** (DRUG) — Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis
- **Maraviroc** (DRUG) — Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis

## Primary Outcomes

- **Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)** _(time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.)_ — 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).
- **AUCtau** _(time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.)_ — 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).
- **Maximum Observed Plasma Concentration (Cmax)** _(time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.)_ — Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).

## Secondary Outcomes

- **Plasma Protein Binding** _(time frame: 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)** _(time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72)_
- **Time of First Occurrence (Tmax)** _(time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.)_
- **Half-life (t1/2)** _(time frame: 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** _(time frame: 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.)_
- **Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae** _(time frame: 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.)_
- **Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD** _(time frame: Before dialysis)_
- **Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure** _(time frame: Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up)_
- **Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute** _(time frame: Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up)_
- **Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals** _(time frame: Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up)_

## Locations (2)

- Pfizer Investigational Site, Berlin, Germany
- Pfizer Investigational Site, München, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer investigational site|berlin||germany` — added _(2026-05-12)_
- `locations.pfizer investigational site|münchen||germany` — added _(2026-05-12)_

---

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