A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT01327547

Collaborator

Pfizer (Industry)

138

Enrollment

Locations

Arms

46.2

Actual Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

Condition or Disease	Intervention/Treatment	Phase
HIV Coinfection	Drug: Maraviroc Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus

Actual Study Start Date :

May 18, 2011

Actual Primary Completion Date :

Apr 23, 2013

Actual Study Completion Date :

Mar 24, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.0	Drug: Maraviroc 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy Other Names: Selzentry, Celsentri
Placebo Comparator: 2	Drug: Placebo 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

Arm

Intervention/Treatment

Experimental: 1.0

Drug: Maraviroc

150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

Other Names:

Selzentry, Celsentri

Placebo Comparator: 2

Drug: Placebo

150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48 [48 weeks]
Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.

Secondary Outcome Measures

Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144 [Week 96 and 144]
Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities [144 weeks]
Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L [144 weeks]
Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L [144 weeks]
Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Number of Participants With Hy's Law Abnormalities Through Week 144 [144 weeks]
Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144 [Week 48, 96 and 144]
The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the "virology-first principle" and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 [Week 48, 96 and 144]
Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144 [48, 96 and 144 weeks]
Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144. [48, 96 and 144 weeks]
Plasma samples were used to determine markers of immune activation namely CRP.
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144 [48, 96 and 144 weeks]
Plasma samples were used to determine markers of immune activation namely D-Dimer.
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144 [48, 96 and 144 weeks]
Plasma samples were used to determine markers of immune activation namely TGF beta.
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144 [48, 96 and 144 weeks]
Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144 [48, 96 and 144 weeks]
Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144 [48, 96 and 144 weeks]
The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144 [48, 96 and 144 weeks]
Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.
Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144 [Baseline and Week 144]
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144 [Week 144]
Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144 [144 Weeks]
Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.
Summary of Estimated Maraviroc PK Parameters [Week 48]
Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.
Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48 [Week 48]
The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HIV coinfected with HCV and/or HBV.
Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.

Exclusion Criteria:

Currently receiving maraviroc.
Active opportunistic infections.
ALT and/or AST >5x upper limit of normal.
Direct bilirubin >1.5x upper limit of normal.
Severe or decompensated liver disease.
Liver disease unrelated to viral hepatitis infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Office of Dr. Franco Antonio Felizarta, M.D.	Bakersfield	California	United States	93301
2	AIDS Research Alliance	Los Angeles	California	United States	90015
3	Alameda Health System - Highland Hospital	Oakland	California	United States	94602
4	University of California Davis Research	Sacramento	California	United States	95811
5	University of California	Sacramento	California	United States	95817
6	University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)	San Francisco	California	United States	94110
7	University of California, San Francisco - Mt. Zion Hospital	San Francisco	California	United States	94115
8	Community AIDS Resource Inc dba Care Resource	Miami	Florida	United States	33137
9	University of South Florida Health - HIV Clinical Research Unit	Tampa	Florida	United States	33602
10	Rowan Tree Medical, P.A.	Wilton Manors	Florida	United States	33305
11	Georgia Regents Medical Center	Augusta	Georgia	United States	30912
12	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
13	Henry Ford Hospital	Detroit	Michigan	United States	48202
14	Saint Michael's Medical Center	Newark	New Jersey	United States	07102
15	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
16	Mount Sinai Faculty Practice Associates	New York	New York	United States	10029
17	The Mount Sinai Hospital	New York	New York	United States	10029
18	New York Medical College	Valhalla	New York	United States	10595
19	I.D. Consultants, P.A.	Charlotte	North Carolina	United States	28209
20	Kaiser Permanente Sunnybrook Medical Office	Clackamas	Oregon	United States	97015
21	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
22	Southwest Infectious Disease Clinical Research Inc.	Dallas	Texas	United States	75219
23	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
24	University Health Care Center Downtown	San Antonio	Texas	United States	78207
25	Fakultni nemocnice Brno	Brno		Czechia	625 00
26	Hopital de la Croix Rousse	Lyon cedex 4		France	69317
27	Centre Hospitalier Cochin Saint Vincent de Paul	Paris CEDEX 14		France	75679
28	Hopital Tenon, Service des Maladies Infectieuses	Paris		France	75020
29	EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin		Germany	12157
30	Universitaetsklinikum Bonn, Immunologische Ambulanz HIV	Bonn		Germany	53127
31	ifi - Studien und Projekte GmbH	Hamburg		Germany	20099
32	Universitaetsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246
33	Klinikum der Universitaet zu Koeln	Koeln		Germany	50937
34	Ludwig-Maximilians-Universitaet	Muenchen		Germany	80336
35	Egyesített Szent István és Szent László Kórház Rendelőintézet	Budapest		Hungary	1097
36	EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej	Wroclaw	Dolnoslaskie	Poland	50-220
37	Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy	Bydgoszcz		Poland	85-030
38	SPZOZ Wojewodzki Szpital Zakazny	Warszawa		Poland	01-201
39	Ararat Research Center	Ponce		Puerto Rico	00717-1567
40	Farmacia UPR-CTU	San Juan		Puerto Rico	00935
41	University of Puerto Rico - School of Medicine	San Juan		Puerto Rico	00935
42	Hospital Universitari Vall dHebron	Barcelona		Spain	08035
43	Hospital Reina Sofia Hospital Provincial	Cordoba		Spain	14004
44	Hospital Carlos Iii	Madrid		Spain	28029
45	Hospital Nuestra Señora de Valme	Sevilla		Spain	41014
46	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
47	Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust	London		United Kingdom	SE1 7EH
48	St Stephen's AIDS Trust	London		United Kingdom	SW10 9NH

Sponsors and Collaborators

ViiV Healthcare
Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01327547

Other Study ID Numbers:

A4001098
2010-021994-35

First Posted:

Apr 1, 2011

Last Update Posted:

Dec 6, 2017

Last Verified:

Nov 1, 2017

Keywords provided by ViiV Healthcare

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details	In this study, 138 participants were randomized, of which 137 participants received the study drug. Participants were randomized at 37 sites in 9 countries. Five sites received drug and screened subjects but did not randomize any subjects; 2 sites received drug but did not screen any subjects.
Pre-assignment Detail	One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)	Participants who received placebo in combination with HAART
Period Title: Overall Study
STARTED	70	67
Randomized and Not Treated	0	1
COMPLETED	50	45
NOT COMPLETED	20	22

Baseline Characteristics

Arm/Group Title	Maraviroc	Placebo	Total
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART	Total of all reporting groups
Overall Participants	70	67	137
Age, Customized (Number) [Number]
<18 years	0 0%	0 0%	0 0%
18-44 years	26 37.1%	20 29.9%	46 33.6%
45-64 years	42 60%	47 70.1%	89 65%
≥65 years	2 2.9%	0 0%	2 1.5%
Sex: Female, Male (Count of Participants)
Female	10 14.3%	10 14.9%	20 14.6%
Male	60 85.7%	57 85.1%	117 85.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
Description	Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Number [Percentage of participants]	1.4 2%	1.5 2.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4598
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-0.0020
	Confidence Interval	(2-Sided) 95% -0.0417 to 0.0376
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.

2. Secondary Outcome

Title	Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144
Description	Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Time Frame	Week 96 and 144

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
at Week 96	1.4 2%	3.0 4.5%
at Week 144	2.9 4.1%	4.5 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0167
	Confidence Interval	(2-Sided) 95% -0.0653 to 0.0319
	Parameter Dispersion	Type: Value:
	Estimation Comments	CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0177
	Confidence Interval	(2-Sided) 95% -0.0805 to 0.0452
	Parameter Dispersion	Type: Value:
	Estimation Comments	CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.

3. Secondary Outcome

Title	Time to Development of Grade 3 and Grade 4 ALT Abnormalities
Description	Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.
Time Frame	144 weeks

Outcome Measure Data

Analysis Population Description
Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144. The median time to development was not estimable due to too few events reported under each treatment group.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Median (95% Confidence Interval) [Days]	NA	NA

4. Secondary Outcome

Title	Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L
Description	Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time Frame	144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Grade 3	2.8 4%	4.4 6.6%
Grade 4	1.4 2%	0.0 0%

5. Secondary Outcome

Title	Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L
Description	Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.
Time Frame	144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144. The median time to development was not estimable due to too few events reported under each treatment group.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Median (95% Confidence Interval) [Days]	NA	NA

6. Secondary Outcome

Title	Number of Participants With Hy's Law Abnormalities Through Week 144
Description	Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN
Time Frame	144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Number [participants]	0 0%	0 0%

7. Secondary Outcome

Title	Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144
Description	The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the "virology-first principle" and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).
Time Frame	Week 48, 96 and 144

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 144, LOCF was used if the value at that timepoint was missing.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48	77.1 110.1%	79.1 118.1%
Week 96	67.1 95.9%	70.1 104.6%
Week 144	58.6 83.7%	67.2 100.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-0.0150
	Confidence Interval	(2-Sided) 95% -0.1484 to 0.1185
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0255
	Confidence Interval	(2-Sided) 95% -0.1784 to 0.1274
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0830
	Confidence Interval	(2-Sided) 95% -0.2421 to 0.0761
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.

8. Secondary Outcome

Title	Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144
Description	Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame	Week 48, 96 and 144

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	69	67
CD4+ (week 48, n=69, 67)	3.1 (142.58)	42.0 (166.35)
CD8+ (week 48, n=69, 67)	7.8 (229.53)	28.9 (293.18)
CD4+ (week 96, n=69, 67)	5.1 (146.64)	49.7 (177.18)
CD8+ (week 96, n=69, 67)	-2.7 (228.92)	62.6 (376.67)
CD4+ (week 144, n=69, 67)	17.2 (184.86)	41.7 (200.00)
CD8+ (week 144, n=69, 67)	12.6 (293.82)	44.1 (387.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1174
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in Least Square (LS) Mean
	Estimated Value	-41.12
	Confidence Interval	(2-Sided) 95% -92.72 to 10.49
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in Least Square (LS) Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5930
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-21.96
	Confidence Interval	(2-Sided) 95% -103.05 to 59.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0669
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-48.26
	Confidence Interval	(2-Sided) 95% -99.93 to 3.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1799
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-65.28
	Confidence Interval	(2-Sided) 95% -161.07 to 30.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3859
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-27.71
	Confidence Interval	(2-Sided) 95% -90.71 to 35.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5571
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-31.86
	Confidence Interval	(2-Sided) 95% -138.93 to 75.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144
Description	Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	69	67
Week 48 (n=69, 67)	-12.2 (129.82)	43.0 (135.71)
Week 96 (n=69, 67)	5.4 (134.64)	47.4 (186.74)
Week 144(n=69, 67)	23.4 (169.50)	50.7 (219.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0153
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-56.06
	Confidence Interval	(2-Sided) 95% -101.20 to -10.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0947
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-44.93
	Confidence Interval	(2-Sided) 95% -97.72 to 7.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3595
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-29.75
	Confidence Interval	(2-Sided) 95% -93.74 to 34.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.
Description	Plasma samples were used to determine markers of immune activation namely CRP.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n=70, 67)	0.4 (8.18)	3.1 (26.66)
Week 96 (n=70, 67)	0.0 (5.16)	-0.7 (3.32)
Week 144 (n=70, 67)	0.6 (7.99)	-0.3 (5.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4476
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-2.53
	Confidence Interval	(2-Sided) 95% -9.11 to 4.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3012
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95% -0.61 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4196
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95% -1.33 to 3.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144
Description	Plasma samples were used to determine markers of immune activation namely D-Dimer.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n= 68, 65)	-101.1 (753.24)	-20.4 (215.62)
Week 96 (n= 68, 65)	-88.1 (740.14)	-23.1 (201.55)
Week 144 (n= 68, 65)	-97.4 (768.98)	9.8 (358.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9904
	Comments	Not specifed.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95% -48.66 to 49.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7697
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	10.87
	Confidence Interval	(2-Sided) 95% -62.44 to 84.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5816
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-24.49
	Confidence Interval	(2-Sided) 95% -112.21 to 63.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

12. Secondary Outcome

Title	Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144
Description	Plasma samples were used to determine markers of immune activation namely TGF beta.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n= 67, 66)	64.1 (4857.31)	-165.0 (2584.89)
Week 96 (n= 67, 66)	-227.5 (4417.59)	-296.5 (2200.97)
Week 144 (n= 67, 66)	792.0 (6772.41)	1275.4 (5044.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3786
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	498.04
	Confidence Interval	(2-Sided) 95% -617.33 to 1613.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4388
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	348.70
	Confidence Interval	(2-Sided) 95% -539.61 to 1237.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8559
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-173.57
	Confidence Interval	(2-Sided) 95% -2060.81 to 1713.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

13. Secondary Outcome

Title	Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144
Description	Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n= 45, 45)	-3.2 (0.60)	-3.2 (0.68)
Week 96 (n= 45, 45)	-3.2 (0.50)	-3.4 (0.81)
Week 144 (n= 45, 45)	-3.1 (0.57)	-3.3 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8024
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95% -0.22 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2660
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95% -0.12 to 0.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2855
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95% -0.12 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS mean

14. Secondary Outcome

Title	Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144
Description	Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n= 15, 10)	-2.6 (1.55)	-3.0 (0.11)
Week 96 (n= 15, 14)	-3.3 (0.94)	-3.0 (0.00)
Week 144 (n= 15, 15)	-3.4 (0.96)	-3.0 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7778
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95% -0.93 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9991
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95% -0.10 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7275
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95% -0.16 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

15. Secondary Outcome

Title	Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144
Description	The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Week 48 (n= 70, 67)	0.2 (0.70)	0.1 (0.71)
Week 96 (n= 70, 67)	0.4 (0.73)	0.4 (0.58)
Week 144 (n= 70, 67)	0.4 (0.72)	0.4 (0.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5201
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95% -0.15 to 0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4657
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.28 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8087
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95% -0.25 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

16. Secondary Outcome

Title	Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144
Description	Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.
Time Frame	48, 96 and 144 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	25	28
Week 48 (n= 25, 28)	-1.3 (2.41)	0.4 (5.71)
Week 96 (n= 25, 28)	-0.8 (2.95)	0.4 (5.70)
Week 144 (n= 25, 28)	-1.7 (2.45)	-0.3 (4.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1417
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-1.84
	Confidence Interval	(2-Sided) 95% -4.31 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2679
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-1.44
	Confidence Interval	(2-Sided) 95% -4.01 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc, Placebo
	Comments	Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1366
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-1.48
	Confidence Interval	(2-Sided) 95% -3.45 to 0.49
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference in LS Mean

17. Secondary Outcome

Title	Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144
Description	Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Time Frame	Baseline and Week 144

Outcome Measure Data

Analysis Population Description
Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	5	4
Absolute Values at Baseline	2.6 (2.30)	1.5 (3.0)
Absolute Values at Post-dose (or Week 144)	2.2 (1.30)	1.5 (3.0)

18. Secondary Outcome

Title	Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144
Description	Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.
Time Frame	Week 144

Outcome Measure Data

Analysis Population Description
Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	5	4
Absolute Values at Baseline	3	0
Absolute Values at Post-dose (or Week 144)	2	0
Change from baseline in fibrosis score at Week 144	0.0	0.0

19. Secondary Outcome

Title	Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144
Description	Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.
Time Frame	144 Weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Arm/Group Title	Maraviroc	Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART	Participants who received placebo in combination with HAART
Measure Participants	70	67
Not Hospitalized	71.4 102%	70.1 104.6%
Hospitalized due to Hepatic Disease at least once	10.0 14.3%	5.0 7.5%
Hospitalized, but not due to Hepatic Disease	95.0 135.7%	95.0 141.8%

20. Secondary Outcome

Title	Summary of Estimated Maraviroc PK Parameters
Description	Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK data available.

Arm/Group Title	Maraviroc 150 mg	Maraviroc 300 mg	Maraviroc 600 mg
Arm/Group Description	Participants received Maraviroc 150 mg twice a day (BID) in combination with a potent CYP3A4 inhibitor	Participants received Maraviroc 300mg BID in the absence of a potent CYP3A4 inhibitor and inducer	Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)
Measure Participants	31	8	28
Cavg	262	166	309
Cmax	496	258	915
Cmin	127.2	61.3	69.2

21. Secondary Outcome

Title	Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48
Description	The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK and liver fibrosis biomarker data available.

Arm/Group Title	Aspartate Transaminase (AST)	Alanine Transaminase (ALT)	Bilirubin (BIL)	Enhanced Liver Fibrosis (ELF)	Fibroscan (FSCN)	Alkaline Phosphatase (ALK)
Arm/Group Description	The p-value of change in AST levels from baseline versus MVC Cavg at Week 48.	The p-value of change in ALT levels from baseline versus MVC Cavg at Week 48.	The p-value of change in BIL from baseline versus MVC Cavg at Week 48.	The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Measure Participants	67	67	67	67	24	67
Number [p-value]	0.892	0.440	0.766	0.795	0.087	0.071

Adverse Events

	Maraviroc		Placebo
Time Frame	From the date of signing informed consent form up to 30 days after last dose of the study drug.
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Maraviroc		Placebo
Arm/Group Description	Participants who received maraviroc in combination with HAART		Participants who received placebo in combination with HAART
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Maraviroc		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/70 (31.4%)		19/67 (28.4%)
Cardiac disorders
Angina pectoris	0/70 (0%)		1/67 (1.5%)
Atrial flutter	1/70 (1.4%)		0/67 (0%)
Bradycardia	1/70 (1.4%)		0/67 (0%)
Myocardial infarction	0/70 (0%)		1/67 (1.5%)
Supraventricular tachycardia	0/70 (0%)		1/67 (1.5%)
Acute myocardial infarction	0/70 (0%)		1/67 (1.5%)
Endocrine disorders
Adrenal insufficiency	0/70 (0%)		1/67 (1.5%)
Cushingoid	0/70 (0%)		1/67 (1.5%)
Eye disorders
Cataract nuclear	1/70 (1.4%)		0/67 (0%)
Gastrointestinal disorders
Gastritis	0/70 (0%)		1/67 (1.5%)
General disorders
Chest pain	0/70 (0%)		1/67 (1.5%)
Hepatobiliary disorders
Cholangitis	1/70 (1.4%)		0/67 (0%)
Cholecystitis chronic	0/70 (0%)		1/67 (1.5%)
Infections and infestations
Appendicitis	1/70 (1.4%)		0/67 (0%)
Bronchopneumonia	3/70 (4.3%)		0/67 (0%)
Cellulitis	0/70 (0%)		1/67 (1.5%)
Pneumonia necrotising	1/70 (1.4%)		0/67 (0%)
Sepsis	1/70 (1.4%)		0/67 (0%)
Clostridium difficile colitis	0/70 (0%)		1/67 (1.5%)
Epididymitis	1/70 (1.4%)		0/67 (0%)
Herpes zoster	0/70 (0%)		1/67 (1.5%)
Influenza	1/70 (1.4%)		0/67 (0%)
Mycobacterium avium complex infection	1/70 (1.4%)		0/67 (0%)
Peritonitis	1/70 (1.4%)		0/67 (0%)
Pneumonia	1/70 (1.4%)		1/67 (1.5%)
Septic shock	0/70 (0%)		1/67 (1.5%)
Injury, poisoning and procedural complications
Foot fracture	0/70 (0%)		1/67 (1.5%)
Jaw fracture	1/70 (1.4%)		0/67 (0%)
Procedural hypotension	1/70 (1.4%)		0/67 (0%)
Splenic haematoma	0/70 (0%)		1/67 (1.5%)
Spinal fracture	0/70 (0%)		1/67 (1.5%)
Toxicity to various agents	0/70 (0%)		1/67 (1.5%)
Investigations
Alanine aminotransferase increased	0/70 (0%)		1/67 (1.5%)
Aspartate aminotransferase increased	0/70 (0%)		1/67 (1.5%)
Blood glucose increased	1/70 (1.4%)		0/67 (0%)
Blood glucose increased	1/70 (1.4%)		0/67 (0%)
Hepatic enzyme increased	1/70 (1.4%)		0/67 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/70 (1.4%)		0/67 (0%)
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement	1/70 (1.4%)		0/67 (0%)
Osteoarthritis	1/70 (1.4%)		0/67 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer	0/70 (0%)		1/67 (1.5%)
Hepatocellular carcinoma	1/70 (1.4%)		0/67 (0%)
Nervous system disorders
Syncope	2/70 (2.9%)		0/67 (0%)
Headache	0/70 (0%)		1/67 (1.5%)
Hypoxic-ischaemic encephalopathy	1/70 (1.4%)		0/67 (0%)
Seizure	1/70 (1.4%)		0/67 (0%)
Ischaemic stroke	1/70 (1.4%)		0/67 (0%)
Psychiatric disorders
Pyschotic disorder	0/70 (0%)		1/67 (1.5%)
Suicidal ideation	0/70 (0%)		1/67 (1.5%)
Renal and urinary disorders
Nephrolithiasis	0/70 (0%)		1/67 (1.5%)
Reproductive system and breast disorders
Breast calcifications	0/70 (0%)		1/67 (1.5%)
Fibrocystic breast disease	0/70 (0%)		1/67 (1.5%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/70 (1.4%)		0/67 (0%)
Chronic obstructive pulmonary disease	1/70 (1.4%)		1/67 (1.5%)
Non-cardiogenic pulmonary oedema	0/70 (0%)		1/67 (1.5%)
Cough	1/70 (1.4%)		0/67 (0%)
Pulmonary mass	1/70 (1.4%)		0/67 (0%)
Surgical and medical procedures
Arthrodesis	1/70 (1.4%)		0/67 (0%)
Vascular disorders
Hypotension	0/70 (0%)		1/67 (1.5%)
Other (Not Including Serious) Adverse Events
	Maraviroc		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	63/70 (90%)		62/67 (92.5%)
Blood and lymphatic system disorders
Anaemia	2/70 (2.9%)		1/67 (1.5%)
Lymphadenopathy	1/70 (1.4%)		0/67 (0%)
Thrombocytopenia	1/70 (1.4%)		1/67 (1.5%)
Cardiac disorders
Angina pectoris	0/70 (0%)		2/67 (3%)
Supraventricular tachycardia	1/70 (1.4%)		0/67 (0%)
Tachycardia	1/70 (1.4%)		0/67 (0%)
Ear and labyrinth disorders
Deafness	0/70 (0%)		1/67 (1.5%)
Ear pain	1/70 (1.4%)		0/67 (0%)
Tinnitus	1/70 (1.4%)		1/67 (1.5%)
Vertigo	2/70 (2.9%)		3/67 (4.5%)
Vertigo positional	1/70 (1.4%)		0/67 (0%)
Hearing impaired	1/70 (1.4%)		0/67 (0%)
Hypoacusis	0/70 (0%)		1/67 (1.5%)
Endocrine disorders
Basedow's disease	0/70 (0%)		1/67 (1.5%)
Hypogonadism	0/70 (0%)		1/67 (1.5%)
Hypothyroidism	0/70 (0%)		1/67 (1.5%)
Eye disorders
Arteriosclerotic retinopathy	1/70 (1.4%)		0/67 (0%)
Chalazion	0/70 (0%)		1/67 (1.5%)
Conjunctival hyperaemia	1/70 (1.4%)		0/67 (0%)
Eye swelling	1/70 (1.4%)		0/67 (0%)
Retinopathy	1/70 (1.4%)		0/67 (0%)
Blepharitis	1/70 (1.4%)		0/67 (0%)
Eye disorder	1/70 (1.4%)		0/67 (0%)
Retinopathy hypertensive	0/70 (0%)		1/67 (1.5%)
Endocrine ophthalmopathy	0/70 (0%)		1/67 (1.5%)
Glaucoma	0/70 (0%)		1/67 (1.5%)
Gastrointestinal disorders
Abdominal discomfort	1/70 (1.4%)		1/67 (1.5%)
Abdominal pain	1/70 (1.4%)		4/67 (6%)
Abdominal pain upper	2/70 (2.9%)		0/67 (0%)
Anal fissure	0/70 (0%)		1/67 (1.5%)
Anal haemorrhage	0/70 (0%)		1/67 (1.5%)
Constipation	2/70 (2.9%)		0/67 (0%)
Diarrhoea	8/70 (11.4%)		12/67 (17.9%)
Dry mouth	1/70 (1.4%)		0/67 (0%)
Dyspepsia	1/70 (1.4%)		2/67 (3%)
Faecaloma	0/70 (0%)		1/67 (1.5%)
Flatulence	1/70 (1.4%)		0/67 (0%)
Gastritis	0/70 (0%)		3/67 (4.5%)
Gastrointestinal disorder	0/70 (0%)		1/67 (1.5%)
Gastrooesophageal reflux disease	1/70 (1.4%)		1/67 (1.5%)
Haemorrhoids	3/70 (4.3%)		1/67 (1.5%)
Hiatus hernia	0/70 (0%)		1/67 (1.5%)
Nausea	7/70 (10%)		9/67 (13.4%)
Proctitis	0/70 (0%)		1/67 (1.5%)
Tongue disorder	1/70 (1.4%)		0/67 (0%)
Tooth loss	0/70 (0%)		1/67 (1.5%)
Toothache	1/70 (1.4%)		7/67 (10.4%)
Vomiting	5/70 (7.1%)		7/67 (10.4%)
Abdominal distension	1/70 (1.4%)		3/67 (4.5%)
Abdominal symptom	1/70 (1.4%)		0/67 (0%)
Abdominal tenderness	1/70 (1.4%)		0/67 (0%)
Anorectal discomfort	0/70 (0%)		1/67 (1.5%)
Duodenogastric reflux	0/70 (0%)		1/67 (1.5%)
Dysphagia	1/70 (1.4%)		0/67 (0%)
Erosive oesophagitis	0/70 (0%)		1/67 (1.5%)
Food poisoning	1/70 (1.4%)		0/67 (0%)
Gingival bleeding	1/70 (1.4%)		0/67 (0%)
Gingival swelling	0/70 (0%)		1/67 (1.5%)
Umbilical hernia	0/70 (0%)		1/67 (1.5%)
General disorders
Asthenia	1/70 (1.4%)		3/67 (4.5%)
Axillary pain	0/70 (0%)		1/67 (1.5%)
Chest pain	3/70 (4.3%)		3/67 (4.5%)
Chills	1/70 (1.4%)		0/67 (0%)
Facial pain	0/70 (0%)		1/67 (1.5%)
Fatigue	5/70 (7.1%)		3/67 (4.5%)
Feeling abnormal	1/70 (1.4%)		0/67 (0%)
Influenza like illness	3/70 (4.3%)		1/67 (1.5%)
Malaise	0/70 (0%)		1/67 (1.5%)
Mucosal inflammation	1/70 (1.4%)		0/67 (0%)
Nodule	0/70 (0%)		2/67 (3%)
Oedema peripheral	2/70 (2.9%)		3/67 (4.5%)
Pyrexia	4/70 (5.7%)		2/67 (3%)
Chest discomfort	0/70 (0%)		1/67 (1.5%)
Inflammation	1/70 (1.4%)		0/67 (0%)
Pain	2/70 (2.9%)		1/67 (1.5%)
Peripheral swelling	1/70 (1.4%)		1/67 (1.5%)
Temperature intolerance	0/70 (0%)		1/67 (1.5%)
Hepatobiliary disorders
Cholestasis	0/70 (0%)		1/67 (1.5%)
Hepatic pain	0/70 (0%)		1/67 (1.5%)
Hepatomegaly	0/70 (0%)		2/67 (3%)
Hyperbilirubinaemia	0/70 (0%)		1/67 (1.5%)
Hypertransaminasaemia	1/70 (1.4%)		0/67 (0%)
Liver disorder	1/70 (1.4%)		0/67 (0%)
Hepatic steatosis	0/70 (0%)		2/67 (3%)
Immune system disorders
Seasonal allergy	3/70 (4.3%)		0/67 (0%)
Infections and infestations
Abscess neck	0/70 (0%)		1/67 (1.5%)
Acarodermatitis	0/70 (0%)		1/67 (1.5%)
Acute tonsillitis	1/70 (1.4%)		0/67 (0%)
Bronchitis	10/70 (14.3%)		7/67 (10.4%)
Cellulitis	1/70 (1.4%)		1/67 (1.5%)
Chlamydial infection	1/70 (1.4%)		0/67 (0%)
Folliculitis	1/70 (1.4%)		1/67 (1.5%)
Gastritis viral	1/70 (1.4%)		0/67 (0%)
Gastroenteritis	4/70 (5.7%)		1/67 (1.5%)
Gingival abscess	0/70 (0%)		1/67 (1.5%)
Herpes simplex	0/70 (0%)		1/67 (1.5%)
Herpes zoster	3/70 (4.3%)		2/67 (3%)
Infection	1/70 (1.4%)		0/67 (0%)
Laryngitis	1/70 (1.4%)		1/67 (1.5%)
Latent tuberculosis	2/70 (2.9%)		0/67 (0%)
Nasopharyngitis	9/70 (12.9%)		6/67 (9%)
Onychomycosis	1/70 (1.4%)		2/67 (3%)
Oral candidiasis	2/70 (2.9%)		0/67 (0%)
Oral herpes	2/70 (2.9%)		1/67 (1.5%)
Oral infection	1/70 (1.4%)		1/67 (1.5%)
Otitis externa	1/70 (1.4%)		2/67 (3%)
Otitis media	3/70 (4.3%)		0/67 (0%)
Otitis media fungal	0/70 (0%)		1/67 (1.5%)
Penile abscess	1/70 (1.4%)		0/67 (0%)
Pharyngitis	5/70 (7.1%)		2/67 (3%)
Pneumonia	0/70 (0%)		5/67 (7.5%)
Rash pustular	1/70 (1.4%)		0/67 (0%)
Respiratory tract infection	2/70 (2.9%)		4/67 (6%)
Rhinitis	2/70 (2.9%)		0/67 (0%)
Schistosomiasis	0/70 (0%)		1/67 (1.5%)
Secondary syphilis	0/70 (0%)		1/67 (1.5%)
Sinusitis	5/70 (7.1%)		4/67 (6%)
Subcutaneous abscess	2/70 (2.9%)		3/67 (4.5%)
Syphilis	3/70 (4.3%)		8/67 (11.9%)
Tinea infection	1/70 (1.4%)		1/67 (1.5%)
Tonsillitis	1/70 (1.4%)		0/67 (0%)
Tooth abscess	3/70 (4.3%)		0/67 (0%)
Tooth infection	4/70 (5.7%)		1/67 (1.5%)
Upper respiratory tract infection	11/70 (15.7%)		11/67 (16.4%)
Urethritis	0/70 (0%)		2/67 (3%)
Urinary tract infection	3/70 (4.3%)		5/67 (7.5%)
Viral infection	6/70 (8.6%)		4/67 (6%)
Acute sinusitis	0/70 (0%)		1/67 (1.5%)
Body tinea	0/70 (0%)		1/67 (1.5%)
Carbuncle	1/70 (1.4%)		0/67 (0%)
Chikungunya virus infection	0/70 (0%)		1/67 (1.5%)
Conjunctivitis	1/70 (1.4%)		1/67 (1.5%)
Ear infection	1/70 (1.4%)		1/67 (1.5%)
Fungal skin infection	1/70 (1.4%)		1/67 (1.5%)
Furuncle	1/70 (1.4%)		0/67 (0%)
Gastroenteritis viral	1/70 (1.4%)		0/67 (0%)
Genital herpes simplex	0/70 (0%)		1/67 (1.5%)
Gingivitis	1/70 (1.4%)		1/67 (1.5%)
Groin abscess	0/70 (0%)		2/67 (3%)
Herpes virus infection	1/70 (1.4%)		0/67 (0%)
Influenza	1/70 (1.4%)		3/67 (4.5%)
Lower respiratory tract infection	0/70 (0%)		1/67 (1.5%)
Mastitis	1/70 (1.4%)		0/67 (0%)
Muscle abscess	0/70 (0%)		1/67 (1.5%)
Oesophageal candidiasis	0/70 (0%)		1/67 (1.5%)
Post procedural infection	0/70 (0%)		1/67 (1.5%)
Proctitis chlamydial	0/70 (0%)		1/67 (1.5%)
Streptococcal infection	1/70 (1.4%)		0/67 (0%)
Vulvovaginal mycotic infection	1/70 (1.4%)		0/67 (0%)
Epididymitis	0/70 (0%)		1/67 (1.5%)
Injury, poisoning and procedural complications
Arthropod sting	0/70 (0%)		2/67 (3%)
Contusion	2/70 (2.9%)		2/67 (3%)
Exposure to communicable disease	1/70 (1.4%)		0/67 (0%)
Fibula fracture	0/70 (0%)		1/67 (1.5%)
Hand fracture	2/70 (2.9%)		0/67 (0%)
Joint injury	0/70 (0%)		1/67 (1.5%)
Laceration	1/70 (1.4%)		3/67 (4.5%)
Ligament sprain	2/70 (2.9%)		2/67 (3%)
Limb injury	0/70 (0%)		1/67 (1.5%)
Muscle strain	0/70 (0%)		3/67 (4.5%)
Procedural pain	1/70 (1.4%)		0/67 (0%)
Radius fracture	0/70 (0%)		1/67 (1.5%)
Spinal compression fracture	0/70 (0%)		1/67 (1.5%)
Bone contusion	0/70 (0%)		1/67 (1.5%)
Epicondylitis	0/70 (0%)		1/67 (1.5%)
Fall	0/70 (0%)		1/67 (1.5%)
Humerus fracture	1/70 (1.4%)		0/67 (0%)
Lower limb fracture	0/70 (0%)		1/67 (1.5%)
Muscle injury	0/70 (0%)		1/67 (1.5%)
Overdose	0/70 (0%)		1/67 (1.5%)
Gastrointestinal injury	1/70 (1.4%)		0/67 (0%)
Wound	2/70 (2.9%)		0/67 (0%)
Investigations
Alanine aminotransferase increased	1/70 (1.4%)		4/67 (6%)
Aspartate aminotransferase increased	0/70 (0%)		2/67 (3%)
Blood creatinine increased	1/70 (1.4%)		1/67 (1.5%)
Blood pressure increased	1/70 (1.4%)		0/67 (0%)
Gamma-glutamyltransferase increased	0/70 (0%)		1/67 (1.5%)
Intraocular pressure increased	0/70 (0%)		1/67 (1.5%)
Lipase increased	0/70 (0%)		3/67 (4.5%)
Transaminases increased	1/70 (1.4%)		0/67 (0%)
Viral load increased	0/70 (0%)		1/67 (1.5%)
Amylase increased	0/70 (0%)		2/67 (3%)
Blood creatine phosphokinase increased	0/70 (0%)		1/67 (1.5%)
Hepatic enzyme increased	0/70 (0%)		1/67 (1.5%)
Liver function test abnormal	0/70 (0%)		1/67 (1.5%)
Weight decreased	1/70 (1.4%)		4/67 (6%)
Anal pap smear abnormal	0/70 (0%)		1/67 (1.5%)
Metabolism and nutrition disorders
Decreased appetite	0/70 (0%)		3/67 (4.5%)
Dyslipidaemia	0/70 (0%)		2/67 (3%)
Gout	0/70 (0%)		2/67 (3%)
Hypercholesterolaemia	1/70 (1.4%)		1/67 (1.5%)
Hypertriglyceridaemia	2/70 (2.9%)		0/67 (0%)
Obesity	0/70 (0%)		1/67 (1.5%)
Hyperglycaemia	1/70 (1.4%)		0/67 (0%)
Hypophosphataemia	1/70 (1.4%)		0/67 (0%)
Vitamin D deficiency	2/70 (2.9%)		3/67 (4.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/70 (10%)		6/67 (9%)
Back pain	4/70 (5.7%)		10/67 (14.9%)
Bursitis	0/70 (0%)		3/67 (4.5%)
Flank pain	1/70 (1.4%)		1/67 (1.5%)
Intervertebral disc protrusion	0/70 (0%)		1/67 (1.5%)
Joint effusion	0/70 (0%)		1/67 (1.5%)
Muscle spasms	1/70 (1.4%)		0/67 (0%)
Muscular weakness	2/70 (2.9%)		0/67 (0%)
Musculoskeletal chest pain	0/70 (0%)		2/67 (3%)
Musculoskeletal pain	0/70 (0%)		4/67 (6%)
Musculoskeletal stiffness	0/70 (0%)		1/67 (1.5%)
Myalgia	2/70 (2.9%)		2/67 (3%)
Pain in extremity	3/70 (4.3%)		7/67 (10.4%)
Pain in jaw	1/70 (1.4%)		0/67 (0%)
Rotator cuff syndrome	0/70 (0%)		1/67 (1.5%)
Spinal osteoarthritis	1/70 (1.4%)		0/67 (0%)
Arthritis	1/70 (1.4%)		1/67 (1.5%)
Costochondritis	1/70 (1.4%)		0/67 (0%)
Gouty arthritis	1/70 (1.4%)		0/67 (0%)
Intervertebral disc disorder	1/70 (1.4%)		0/67 (0%)
Musculoskeletal discomfort	1/70 (1.4%)		0/67 (0%)
Neck pain	0/70 (0%)		1/67 (1.5%)
Osteopenia	1/70 (1.4%)		0/67 (0%)
Spondylitis	0/70 (0%)		2/67 (3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/70 (0%)		1/67 (1.5%)
Skin papilloma	0/70 (0%)		1/67 (1.5%)
Lipoma	1/70 (1.4%)		0/67 (0%)
Oral papilloma	1/70 (1.4%)		0/67 (0%)
Nervous system disorders
Ageusia	1/70 (1.4%)		0/67 (0%)
Amnesia	1/70 (1.4%)		1/67 (1.5%)
Burning sensation	0/70 (0%)		1/67 (1.5%)
Carpal tunnel syndrome	1/70 (1.4%)		0/67 (0%)
Cervicobrachial syndrome	0/70 (0%)		1/67 (1.5%)
Complex regional pain syndrome	1/70 (1.4%)		0/67 (0%)
Dizziness	4/70 (5.7%)		6/67 (9%)
Dysaesthesia	2/70 (2.9%)		0/67 (0%)
Dysgeusia	0/70 (0%)		1/67 (1.5%)
Headache	6/70 (8.6%)		5/67 (7.5%)
Hypertonia	1/70 (1.4%)		0/67 (0%)
Hypoaesthesia	1/70 (1.4%)		1/67 (1.5%)
Intercostal neuralgia	1/70 (1.4%)		0/67 (0%)
Migraine	3/70 (4.3%)		3/67 (4.5%)
Sciatica	1/70 (1.4%)		2/67 (3%)
Somnolence	0/70 (0%)		2/67 (3%)
Aphasia	1/70 (1.4%)		0/67 (0%)
Disturbance in attention	0/70 (0%)		1/67 (1.5%)
Dyskinesia	0/70 (0%)		1/67 (1.5%)
Epilepsy	1/70 (1.4%)		0/67 (0%)
Hemiparesis	1/70 (1.4%)		0/67 (0%)
Loss of consciousness	0/70 (0%)		1/67 (1.5%)
Neuropathy peripheral	1/70 (1.4%)		0/67 (0%)
VIIth nerve paralysis	0/70 (0%)		1/67 (1.5%)
Psychiatric disorders
Abnormal dreams	0/70 (0%)		1/67 (1.5%)
Anxiety	0/70 (0%)		4/67 (6%)
Depression	5/70 (7.1%)		4/67 (6%)
Dissociation	1/70 (1.4%)		0/67 (0%)
Insomnia	5/70 (7.1%)		6/67 (9%)
Nightmare	0/70 (0%)		1/67 (1.5%)
Sleep disorder	1/70 (1.4%)		2/67 (3%)
Alcohol abuse	0/70 (0%)		1/67 (1.5%)
Alcoholism	0/70 (0%)		1/67 (1.5%)
Hallucination, auditory	0/70 (0%)		1/67 (1.5%)
Paranoia	0/70 (0%)		1/67 (1.5%)
Substance abuse	1/70 (1.4%)		1/67 (1.5%)
Suicidal ideation	1/70 (1.4%)		0/67 (0%)
Renal and urinary disorders
Dysuria	2/70 (2.9%)		2/67 (3%)
Haematuria	0/70 (0%)		1/67 (1.5%)
Leukocyturia	1/70 (1.4%)		1/67 (1.5%)
Micturition urgency	0/70 (0%)		1/67 (1.5%)
Nephrolithiasis	1/70 (1.4%)		2/67 (3%)
Renal cyst	1/70 (1.4%)		0/67 (0%)
Urinary hesitation	1/70 (1.4%)		0/67 (0%)
Bladder prolapse	0/70 (0%)		1/67 (1.5%)
Pollakiuria	1/70 (1.4%)		1/67 (1.5%)
Polyuria	0/70 (0%)		1/67 (1.5%)
Urethral discharge	0/70 (0%)		1/67 (1.5%)
Urinary incontinence	0/70 (0%)		1/67 (1.5%)
Reproductive system and breast disorders
Breast mass	0/70 (0%)		2/67 (3%)
Erectile dysfunction	1/70 (1.4%)		0/67 (0%)
Genital rash	0/70 (0%)		1/67 (1.5%)
Prostatitis	1/70 (1.4%)		1/67 (1.5%)
Pruritus genital	0/70 (0%)		1/67 (1.5%)
Testicular pain	0/70 (0%)		1/67 (1.5%)
Genital lesion	0/70 (0%)		1/67 (1.5%)
Gynaecomastia	0/70 (0%)		1/67 (1.5%)
Prostatic disorder	0/70 (0%)		1/67 (1.5%)
Vulvovaginal pruritus	0/70 (0%)		1/67 (1.5%)
Vulvovaginal swelling	0/70 (0%)		1/67 (1.5%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/70 (1.4%)		1/67 (1.5%)
Cough	9/70 (12.9%)		2/67 (3%)
Dyspnoea	1/70 (1.4%)		2/67 (3%)
Haemoptysis	0/70 (0%)		1/67 (1.5%)
Nasal congestion	0/70 (0%)		1/67 (1.5%)
Oropharyngeal pain	4/70 (5.7%)		2/67 (3%)
Pharyngeal erythema	2/70 (2.9%)		0/67 (0%)
Productive cough	0/70 (0%)		1/67 (1.5%)
Sinus congestion	0/70 (0%)		1/67 (1.5%)
Sneezing	0/70 (0%)		1/67 (1.5%)
Bronchial hyperreactivity	1/70 (1.4%)		0/67 (0%)
Chronic obstructive pulmonary disease	0/70 (0%)		1/67 (1.5%)
Dry throat	1/70 (1.4%)		0/67 (0%)
Epistaxis	0/70 (0%)		1/67 (1.5%)
Pulmonary hypertension	0/70 (0%)		1/67 (1.5%)
Pulmonary mass	1/70 (1.4%)		0/67 (0%)
Sinus disorder	0/70 (0%)		1/67 (1.5%)
Throat irritation	0/70 (0%)		1/67 (1.5%)
Skin and subcutaneous tissue disorders
Acne	1/70 (1.4%)		1/67 (1.5%)
Alopecia	1/70 (1.4%)		2/67 (3%)
Dermatitis	2/70 (2.9%)		1/67 (1.5%)
Hyperhidrosis	0/70 (0%)		1/67 (1.5%)
Night sweats	3/70 (4.3%)		1/67 (1.5%)
Pruritus	4/70 (5.7%)		6/67 (9%)
Rash	5/70 (7.1%)		3/67 (4.5%)
Rash maculo-papular	1/70 (1.4%)		0/67 (0%)
Rosacea	0/70 (0%)		1/67 (1.5%)
Seborrhoeic dermatitis	1/70 (1.4%)		0/67 (0%)
Skin lesion	2/70 (2.9%)		3/67 (4.5%)
Skin mass	0/70 (0%)		1/67 (1.5%)
Actinic keratosis	0/70 (0%)		1/67 (1.5%)
Dermatitis allergic	1/70 (1.4%)		1/67 (1.5%)
Dermatitis allergic	1/70 (1.4%)		0/67 (0%)
Dermatitis contact	1/70 (1.4%)		0/67 (0%)
Dry skin	1/70 (1.4%)		1/67 (1.5%)
Dyshidrotic eczema	1/70 (1.4%)		0/67 (0%)
Eczema	1/70 (1.4%)		1/67 (1.5%)
Erythema	0/70 (0%)		1/67 (1.5%)
Onycholysis	1/70 (1.4%)		0/67 (0%)
Rash papular	1/70 (1.4%)		0/67 (0%)
Skin fissures	1/70 (1.4%)		0/67 (0%)
Skin plaque	0/70 (0%)		1/67 (1.5%)
Skin ulcer	0/70 (0%)		1/67 (1.5%)
Spider naevus	1/70 (1.4%)		0/67 (0%)
Swelling face	1/70 (1.4%)		0/67 (0%)
Rash pruritic	0/70 (0%)		1/67 (1.5%)
Social circumstances
Menopause	1/70 (1.4%)		0/67 (0%)
Surgical and medical procedures
Abdominal hernia repair	0/70 (0%)		1/67 (1.5%)
Skin lesion excision	1/70 (1.4%)		0/67 (0%)
Tooth extraction	0/70 (0%)		1/67 (1.5%)
Cataract operation	0/70 (0%)		1/67 (1.5%)
Vascular disorders
Haematoma	0/70 (0%)		1/67 (1.5%)
Hot flush	0/70 (0%)		2/67 (3%)
Hypertension	4/70 (5.7%)		3/67 (4.5%)
Hypotension	1/70 (1.4%)		1/67 (1.5%)
Varicose vein	1/70 (1.4%)		1/67 (1.5%)
Deep vein thrombosis	0/70 (0%)		2/67 (3%)
Peripheral venous disease	0/70 (0%)		1/67 (1.5%)

Limitations/Caveats

The median time to development of Grade 3 and 4 ALT abnormalities was not estimable due to too few events reported under each treatment group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01327547

Other Study ID Numbers:

A4001098
2010-021994-35

First Posted:

Apr 1, 2011

Last Update Posted:

Dec 6, 2017

Last Verified:

Nov 1, 2017