Human Immunodeficiency Virus (HIV) InfectionPhase 4NCT00717067

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

A Phase 4 study testing Maraviroc, Ritonavir and Saquinavir in people with Human Immunodeficiency Virus (HIV) Infection, run by ViiV Healthcare at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus (HIV) Infection
What is being tested?: Maraviroc, Ritonavir and Saquinavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesGermany
Study dates: Jul 2008to Nov 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

2 sites in 1 country.

Germany2 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
München, 81241

Other trials in Germany

About this study

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

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
Being tested: Maraviroc, Ritonavir, Saquinavir
Keywords: maraviroc, pharmacokinetics, renal impairment
Medical subject headings: Acquired Immunodeficiency Syndrome, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00717067
Study group	Role	What they receive
Healthy Subjects	Experimental	Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir Receives: Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir
Mild Renal Impairment	Experimental	Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min) Receives: Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir
Moderate Renal Impairment	Experimental	Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min) Receives: Drug: Maraviroc; Drug: Ritonavir; Drug: Saquinavir
Severe Renal Impairment	Experimental	Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min) Receives: 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 Receives: Drug: Maraviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Plasma Protein Binding
Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.
Measured: 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)
Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).
Measured: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72
Time of First Occurrence (Tmax)
Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.
Measured: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.
Half-life (t1/2)
Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.
Measured: 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
Renal clearance (CLR) measured in milliliters per minute (mL/min).
Measured: 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
Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).
Measured: 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
CLdD: dialysate clearance before dialysis; measured in milliliters per minute.
Measured: 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
Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.
Measured: 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
Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.
Measured: 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
Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Nov 2008

First posted16 Jul 2008 (estimated)
Study startJul 2008
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717067
Sponsor's protocol ID: A4001075
Status last verified: Nov 2010
First submitted: 15 Jul 2008
Last updated: 19 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus (HIV) Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00717067
Acronym / sponsor ID: A4001075
Conditions: Human Immunodeficiency Virus (HIV) Infection
Keywords: maraviroc, pharmacokinetics, renal impairment
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Jul 2008
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 16 Jul 2008 (estimated)
Results: Posted 21 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Healthy Subjects	Experimental	Drug: Maraviroc, Drug: Ritonavir, Drug: SaquinavirSubjects with Normal Renal Function (Creatinine Clearance > 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir
Mild Renal Impairment	Experimental	Drug: Maraviroc, Drug: Ritonavir, Drug: SaquinavirSubjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
Moderate Renal Impairment	Experimental	Drug: Maraviroc, Drug: Ritonavir, Drug: SaquinavirSubjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
Severe Renal Impairment	Experimental	Drug: MaravirocSubjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
ESRD on Hemodialysis	Experimental	Drug: MaravirocSubjects 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

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MaravirocMaraviroc 300 mg (150 mg x 2 tablets) x single dose	Drug	Healthy Subjects
MaravirocMaraviroc 150 mg tablet twice daily x 7 days	Drug	Healthy Subjects
RitonavirRitonavir 100 mg capsule twice daily x 7 days	Drug	Healthy Subjects
SaquinavirSaquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days	Drug	Healthy Subjects
MaravirocMaraviroc 150 mg tablet once daily x 7 days	Drug	Mild Renal Impairment
RitonavirRitonavir 100 mg capsule twice daily x 7 days	Drug	Mild Renal Impairment
SaquinavirSaquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days	Drug	Mild Renal Impairment
MaravirocMaraviroc 150 mg tablet once every 48 hours x 7 days	Drug	Moderate Renal Impairment
RitonavirRitonavir 100 mg capsule twice daily x 7 days	Drug	Moderate Renal Impairment
SaquinavirSaquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days	Drug	Moderate Renal Impairment
MaravirocMaraviroc 300 mg (150 mg x 2 tablets) x single dose	Drug	Severe Renal Impairment
MaravirocMaraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis	Drug	ESRD on Hemodialysis
MaravirocMaraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis	Drug	ESRD on Hemodialysis

Primary outcome

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).

10 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

Results and safety

Results posted to the registry on 21 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Subjects	6	6
Mild Renal Impairment	6	6
Moderate Renal Impairment	6	5
Severe Renal Impairment	0	0
ESRD: Single Dose	0	0

Primary outcome: 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.. Geometric mean (Standard Deviation). Unit: ng*hr/mL

Measure	Healthy Subjects: Multiple Dose n = 6	Mild Renal Impairment: Multiple Dose n = 6	Moderate Renal Impairment: Multiple Dose n = 5	Healthy Subjects: Single Dose n = 6	Severe Renal Impairment: Single Dose n = 6	ESRD: Single Dose; After Dialysis n = 6	ESRD: Single Dose; Before Dialysis n = 6
Value	7356.3 (2313.45)	9502.1 (3599.32)	6496.0 (1795.89)	1320.7 (988.66)	4255.5 (2424.19)	2636.5 (1123.34)	2770.1 (1356.56)

Healthy Subjects: Multiple Dose vs Mild Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 129.17 (90% CI 92.16 to 181.04), ANOVA
Healthy Subjects: Multiple Dose vs Moderate Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 88.31 (90% CI 61.97 to 125.83), ANOVA
Healthy Subjects: Single Dose vs Severe Renal Impairment: Single Dose: ratio of adjusted geometric means: 322.23 (90% CI 171.97 to 603.78), ANOVA

Population analysed: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.

Primary outcome: AUCtau

Time frame: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.. Geometric mean (Standard Deviation). Unit: ng*hr/mL

Measure	Healthy Subjects: Multiple Dose n = 6	Mild Renal Impairment: Multiple Dose n = 6	Moderate Renal Impairment: Multiple Dose n = 5
Value	5341.4 (1498.27)	8118.7 (2995.27)	6193.3 (1762.41)

Healthy Subjects: Multiple Dose vs Mild Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 151.99 (90% CI 109.53 to 210.92), ANOVA
Healthy Subjects: Multiple Dose vs Moderate Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 115.95 (90% CI 82.23 to 163.50), ANOVA

Population analysed: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.

Primary outcome: 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.. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Healthy Subjects: Multiple Dose n = 6	Mild Renal Impairment: Multiple Dose n = 6	Moderate Renal Impairment: Multiple Dose n = 5	Healthy Subjects: Single Dose n = 6	Severe Renal Impairment: Single Dose n = 6	ESRD: Single Dose; After Dialysis n = 6	ESRD: Single Dose; Before Dialysis n = 6
Value	950.91 (220.368)	1150.74 (392.167)	674.20 (275.722)	335.60 (393.024)	801.16 (525.656)	576.7 (339.27)	478.5 (198.81)

Healthy Subjects: Multiple Dose vs Mild Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 121.01 (90% CI 83.15 to 176.13), ANOVA
Healthy Subjects: Multiple Dose vs Moderate Renal Impairment: Multiple Dose: ratio of adjusted geometric means: 70.90 (90% CI 47.83 to 105.10), ANOVA
Healthy Subjects: Single Dose vs Severe Renal Impairment: Single Dose: ratio of adjusted geometric means: 238.73 (90% CI 106.83 to 533.48), ANOVA

Population analysed: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Subjects	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Mild Renal Impairment	0 of 6 (0%)	6 of 6 (100%)	Not reported
Moderate Renal Impairment	0 of 6 (0%)	6 of 6 (100%)	Not reported
Healthy Subjects: Single Dose	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Severe Renal Impairment:	0 of 6 (0%)	3 of 6 (50%)	Not reported
ESRD: Dosing After Dialysis	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
ESRD: Dosing Before Dialysis	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Maraviroc, Ritonavir and Saquinavir in people with Human Immunodeficiency Virus (HIV) Infection, run by ViiV Healthcare at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.