Pharmacokinetics, Safety And Toleration Of Maraviroc Admi... | NCT00717067

NCT00717067

Status Module

Sponsor/Collaborators Module

Name	Class
Pfizer	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Maraviroc	Drug	Maraviroc 300 mg (150 mg x 2 tablets) x single dose	Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Plasma Protein Binding	Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.	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)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Berlin		10117	Germany
Pfizer Investigational Site

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Healthy Subjects	(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
FG001	Mild Renal Impairment

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Healthy Subjects	Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
BG001	Mild Renal Impairment	Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
BG002	Moderate Renal Impairment	Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
BG003	Severe Renal Impairment	Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
BG004	ESRD on Hemodialysis	Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

years

Title

Denominators

Categories

Title	Measurements
	OG0007356.3± 2313.45 OG0019502.1± 3599.32 OG0026496.0± 1795.89 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.	ANOVA				ratio of adjusted geometric means	129.17				90	92.16	181.04				No	Superiority or Other
OG000 OG002	Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.

Primary

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).

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.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.

Primary

Maximum Observed Plasma Concentration (Cmax)

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

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

Posted

Geometric Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003	Healthy Subjects: Single Dose

Secondary

Plasma Protein Binding

Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.

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

Posted

Number

percent free

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003	Healthy Subjects: Single Dose

Secondary

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).

Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.

Posted

Geometric Mean

Standard Deviation

ng*hr/mL

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

ID	Title	Description
OG000	Healthy Subjects: Single Dose	Maraviroc 300 mg single dose.
OG001	Severe Renal Impairment: Single Dose	Maraviroc 300 mg single dose.
OG002	ESRD: Single Dose; After Dialysis	Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
OG003	ESRD: Single Dose; Before Dialysis	Maraviroc 300 mg single dose three hours prior to start of hemodialysis.

Secondary

Time of First Occurrence (Tmax)

Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.

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

Posted

Median

Full Range

hours

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003	Healthy Subjects: Single Dose

Secondary

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.

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

Posted

Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003	Healthy Subjects: Single Dose

Secondary

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

Renal clearance (CLR) measured in milliliters per minute (mL/min).

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

Posted

Geometric Mean

Standard Deviation

mL/min

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.

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003

Secondary

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).

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

Posted

Mean

Standard Deviation

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.

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG003

Secondary

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.

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

Posted

Geometric Mean

Standard Deviation

mL/min

Before dialysis

ID	Title	Description
OG000	ESRD: Single Dose; Before Dialysis	Maraviroc 300 mg single dose three hours prior to start of hemodialysis

Units	Counts
Participants	OG000

Secondary

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.

Safety analysis set: all subjects who received study medication. BL: Baseline.

Posted

Number

subjects

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002

Secondary

Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.

Safety analysis set: all subjects who received study medication.

Posted

Number

bpm

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002	Moderate Renal Impairment: Multiple Dose	Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.

Secondary

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.

Safety analysis set: all subjects who received study medication.

Posted

Number

subjects

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

ID	Title	Description
OG000	Healthy Subjects: Multiple Dose	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
OG001	Mild Renal Impairment: Multiple Dose	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
OG002

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Healthy Subjects	Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.	6	2	6
EG001	Mild Renal Impairment	Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.	6	6	6
EG002	Moderate Renal Impairment	Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.	6	6	6
EG003	Healthy Subjects: Single Dose	Maraviroc 300 mg single dose.	6	1	6
EG004	Severe Renal Impairment:	Maraviroc 300 mg single dose.	6	3	6
EG005	ESRD: Dosing After Dialysis	Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.	6	2	6
EG006	ESRD: Dosing Before Dialysis	Maraviroc 300 mg single dose three hours prior to start of hemodialysis.	6	1	6

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
conjunctival hyperaemia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG0030 affected6 at risk EG0040 affected6 at risk EG0050 affected6 at risk EG0060 affected6 at risk
visual impairment	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
abdominal pain upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
diarrhea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
dry mouth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
flatulence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0021 affected6 at risk EG003
pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
sensation of foreign body	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
rhinitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
wound	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
blood bilirubin increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
blood creatinine increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0014 affected6 at risk EG0024 affected6 at risk EG003
blood urea increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0013 affected6 at risk EG0020 affected6 at risk EG003
renal function test abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
hyperuricaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected6 at risk EG0013 affected6 at risk EG0021 affected6 at risk EG003
paraesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
nocturia	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0013 affected6 at risk EG0023 affected6 at risk EG003
renal pain	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
orthostatic hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D052801	Male Urogenital Diseases

ID	Term
D000077592	Maraviroc
D019438	Ritonavir
D019258	Saquinavir

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013844	Thiazoles
D013457	Sulfur Compounds
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011804	Quinolines

OG0044255.5± 2424.19

OG0052636.5± 1123.34

OG0062770.1± 1356.56

Units	Counts
Participants	OG0006 OG0016 OG0025

Maraviroc 300 mg single dose.

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0041 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0041 affected6 at risk

EG0050 affected6 at risk

EG0061 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0061 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

EG0050 affected6 at risk

EG0060 affected6 at risk

EG0040 affected6 at risk

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