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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327547
Recruitment Status : Completed
First Posted : April 1, 2011
Results First Posted : November 14, 2014
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Coinfection
Interventions Drug: Maraviroc
Drug: Placebo
Enrollment 138
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Pre-assignment Details One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.
Arm/Group Title Maraviroc Placebo
Hide 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 [1]
Completed 50 45
Not Completed 20 22
Reason Not Completed
Adverse Event             4             1
Death             1             2
Lost to Follow-up             6             6
Non-Compliance With Study Treatment             0             2
Withdrawal by Subject             3             7
Does Not Meet Entrance Criteria             2             2
Protocol Violation             1             0
Non-compliance due to alcohol intake             0             1
Required prohibited medication             2             0
Non-compliance with study procedures             1             0
By investigator in subject’s interest             0             1
[1]
Randomized but was withdrawn prior to receiving treatment due to poor venous access.
Arm/Group Title Maraviroc Placebo Total
Hide 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 Number of Baseline Participants 70 67 137
Hide Baseline Analysis Population Description
A participant was included in the FAS if the participant had taken at least one dose of study drug.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 67 participants 137 participants
<18 years 0 0 0
18-44 years 26 20 46
45-64 years 42 47 89
≥65 years 2 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 67 participants 137 participants
Female
10
  14.3%
10
  14.9%
20
  14.6%
Male
60
  85.7%
57
  85.1%
117
  85.4%
1.Primary Outcome
Title Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: Percentage of participants
1.4 1.5
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4598
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value -0.0020
Confidence Interval (2-Sided) 95%
-0.0417 to 0.0376
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: Percentage of participants
at Week 96 1.4 3.0
at Week 144 2.9 4.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0167
Confidence Interval (2-Sided) 95%
-0.0653 to 0.0319
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0177
Confidence Interval (2-Sided) 95%
-0.0805 to 0.0452
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: Percentage of participants
Grade 3 2.8 4.4
Grade 4 1.4 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.
6.Secondary Outcome
Title Number of Participants With Hy's Law Abnormalities Through Week 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: participants
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: Percentage of participants
Week 48 77.1 79.1
Week 96 67.1 70.1
Week 144 58.6 67.2
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value -0.0150
Confidence Interval (2-Sided) 95%
-0.1484 to 0.1185
Estimation Comments Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0255
Confidence Interval (2-Sided) 95%
-0.1784 to 0.1274
Estimation Comments Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.
Show Statistical Analysis 3 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0830
Confidence Interval (2-Sided) 95%
-0.2421 to 0.0761
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 69 67
Mean (Standard Deviation)
Unit of Measure: Cells/µL
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.1174
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
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
Estimation Comments Difference in Least Square (LS) Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5930
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -21.96
Confidence Interval (2-Sided) 95%
-103.05 to 59.12
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0669
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -48.26
Confidence Interval (2-Sided) 95%
-99.93 to 3.41
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.1799
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -65.28
Confidence Interval (2-Sided) 95%
-161.07 to 30.50
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.3859
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -27.71
Confidence Interval (2-Sided) 95%
-90.71 to 35.29
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5571
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -31.86
Confidence Interval (2-Sided) 95%
-138.93 to 75.21
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 69 67
Mean (Standard Deviation)
Unit of Measure: cell/mm³
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0153
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -56.06
Confidence Interval (2-Sided) 95%
-101.20 to -10.92
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0947
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -44.93
Confidence Interval (2-Sided) 95%
-97.72 to 7.87
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.3595
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -29.75
Confidence Interval (2-Sided) 95%
-93.74 to 34.24
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.
Hide Description Plasma samples were used to determine markers of immune activation namely CRP.
Time Frame 48, 96 and 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4476
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.53
Confidence Interval (2-Sided) 95%
-9.11 to 4.05
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.3012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-0.61 to 1.96
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4196
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
-1.33 to 3.17
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144
Hide Description Plasma samples were used to determine markers of immune activation namely D-Dimer.
Time Frame 48, 96 and 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: ng/dL
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.9904
Comments Not specifed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-48.66 to 49.26
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.7697
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 10.87
Confidence Interval (2-Sided) 95%
-62.44 to 84.18
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5816
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -24.49
Confidence Interval (2-Sided) 95%
-112.21 to 63.23
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
Hide Description Plasma samples were used to determine markers of immune activation namely TGF beta.
Time Frame 48, 96 and 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: ng/L
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.3786
Comments Not specified
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 498.04
Confidence Interval (2-Sided) 95%
-617.33 to 1613.41
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4388
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 348.70
Confidence Interval (2-Sided) 95%
-539.61 to 1237.01
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.8559
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -173.57
Confidence Interval (2-Sided) 95%
-2060.81 to 1713.68
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: Log10 values
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.8024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.22 to 0.28
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2660
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.12 to 0.43
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2855
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.12 to 0.41
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: Log10 values
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.7778
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.93 to 1.23
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.9991
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.10 to 0.10
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.7275
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.16 to 0.11
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Mean (Standard Deviation)
Unit of Measure: ELF score
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5201
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.15 to 0.30
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.4657
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.28 to 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.8087
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.25 to 0.20
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 25 28
Mean (Standard Deviation)
Unit of Measure: kPa
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.1417
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-4.31 to 0.63
Estimation Comments Difference in LS Mean
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2679
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.44
Confidence Interval (2-Sided) 95%
-4.01 to 1.14
Estimation Comments Difference in LS Mean
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.1366
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.48
Confidence Interval (2-Sided) 95%
-3.45 to 0.49
Estimation Comments Difference in LS Mean
17.Secondary Outcome
Title Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: Numerical score
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 5 4
Median (Full Range)
Unit of Measure: Numerical score
Absolute Values at Baseline
3
(0 to 6)
0
(0 to 6)
Absolute Values at Post-dose (or Week 144)
2
(1 to 4)
0
(0 to 6)
Change from baseline in fibrosis score at Week 144
0.0
(-2.0 to 1.0)
0.0
(0.0 to 0.0)
19.Secondary Outcome
Title Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants who received maraviroc in combination with HAART
Participants who received placebo in combination with HAART
Overall Number of Participants Analyzed 70 67
Measure Type: Number
Unit of Measure: Percentage of participants
Not Hospitalized 71.4 70.1
Hospitalized due to Hepatic Disease at least once 10.0 5.0
Hospitalized, but not due to Hepatic Disease 95.0 95.0
20.Secondary Outcome
Title Summary of Estimated Maraviroc PK Parameters
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Overall Number of Participants Analyzed 31 8 28
Median (Full Range)
Unit of Measure: ng/mL
Cavg
262
(35 to 455)
166
(72 to 187)
309
(79 to 656)
Cmax
496
(47 to 768)
258
(162 to 528)
915
(133 to 1734)
Cmin
127.2
(21.6 to 280.5)
61.3
(19.5 to 112.9)
69.2
(17.3 to 250.9)
21.Secondary Outcome
Title Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 67 67 67 67 24 67
Measure Type: Number
Unit of Measure: p-value
0.892 0.440 0.766 0.795 0.087 0.071
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
Hide Arm/Group Description Participants who received maraviroc in combination with HAART Participants who received placebo in combination with HAART
All-Cause Mortality
Maraviroc Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/70 (31.43%)   19/67 (28.36%) 
Cardiac disorders     
Angina pectoris * 1  0/70 (0.00%)  1/67 (1.49%) 
Atrial flutter * 1  1/70 (1.43%)  0/67 (0.00%) 
Bradycardia * 1  1/70 (1.43%)  0/67 (0.00%) 
Myocardial infarction * 1  0/70 (0.00%)  1/67 (1.49%) 
Supraventricular tachycardia * 1  0/70 (0.00%)  1/67 (1.49%) 
Acute myocardial infarction * 1  0/70 (0.00%)  1/67 (1.49%) 
Endocrine disorders     
Adrenal insufficiency * 1  0/70 (0.00%)  1/67 (1.49%) 
Cushingoid * 1  0/70 (0.00%)  1/67 (1.49%) 
Eye disorders     
Cataract nuclear * 1  1/70 (1.43%)  0/67 (0.00%) 
Gastrointestinal disorders     
Gastritis  2  0/70 (0.00%)  1/67 (1.49%) 
General disorders     
Chest pain  2  0/70 (0.00%)  1/67 (1.49%) 
Hepatobiliary disorders     
Cholangitis  2  1/70 (1.43%)  0/67 (0.00%) 
Cholecystitis chronic * 1  0/70 (0.00%)  1/67 (1.49%) 
Infections and infestations     
Appendicitis  2  1/70 (1.43%)  0/67 (0.00%) 
Bronchopneumonia  2  3/70 (4.29%)  0/67 (0.00%) 
Cellulitis  2  0/70 (0.00%)  1/67 (1.49%) 
Pneumonia necrotising  2  1/70 (1.43%)  0/67 (0.00%) 
Sepsis  2  1/70 (1.43%)  0/67 (0.00%) 
Clostridium difficile colitis * 1  0/70 (0.00%)  1/67 (1.49%) 
Epididymitis * 1  1/70 (1.43%)  0/67 (0.00%) 
Herpes zoster * 1  0/70 (0.00%)  1/67 (1.49%) 
Influenza * 1  1/70 (1.43%)  0/67 (0.00%) 
Mycobacterium avium complex infection * 1  1/70 (1.43%)  0/67 (0.00%) 
Peritonitis * 1  1/70 (1.43%)  0/67 (0.00%) 
Pneumonia * 1  1/70 (1.43%)  1/67 (1.49%) 
Septic shock * 1  0/70 (0.00%)  1/67 (1.49%) 
Injury, poisoning and procedural complications     
Foot fracture  2  0/70 (0.00%)  1/67 (1.49%) 
Jaw fracture  2  1/70 (1.43%)  0/67 (0.00%) 
Procedural hypotension  2  1/70 (1.43%)  0/67 (0.00%) 
Splenic haematoma  2  0/70 (0.00%)  1/67 (1.49%) 
Spinal fracture * 1  0/70 (0.00%)  1/67 (1.49%) 
Toxicity to various agents * 1  0/70 (0.00%)  1/67 (1.49%) 
Investigations     
Alanine aminotransferase increased  2  0/70 (0.00%)  1/67 (1.49%) 
Aspartate aminotransferase increased  2  0/70 (0.00%)  1/67 (1.49%) 
Blood glucose increased  2  1/70 (1.43%)  0/67 (0.00%) 
Blood glucose increased * 1  1/70 (1.43%)  0/67 (0.00%) 
Hepatic enzyme increased * 1  1/70 (1.43%)  0/67 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  2  1/70 (1.43%)  0/67 (0.00%) 
Musculoskeletal and connective tissue disorders     
Femoroacetabular impingement * 1  1/70 (1.43%)  0/67 (0.00%) 
Osteoarthritis * 1  1/70 (1.43%)  0/67 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic cancer * 1  0/70 (0.00%)  1/67 (1.49%) 
Hepatocellular carcinoma * 1  1/70 (1.43%)  0/67 (0.00%) 
Nervous system disorders     
Syncope  2  2/70 (2.86%)  0/67 (0.00%) 
Headache * 1  0/70 (0.00%)  1/67 (1.49%) 
Hypoxic-ischaemic encephalopathy * 1  1/70 (1.43%)  0/67 (0.00%) 
Seizure * 1  1/70 (1.43%)  0/67 (0.00%) 
Ischaemic stroke * 1  1/70 (1.43%)  0/67 (0.00%) 
Psychiatric disorders     
Pyschotic disorder * 1  0/70 (0.00%)  1/67 (1.49%) 
Suicidal ideation * 1  0/70 (0.00%)  1/67 (1.49%) 
Renal and urinary disorders     
Nephrolithiasis  2  0/70 (0.00%)  1/67 (1.49%) 
Reproductive system and breast disorders     
Breast calcifications  2  0/70 (0.00%)  1/67 (1.49%) 
Fibrocystic breast disease  2  0/70 (0.00%)  1/67 (1.49%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  2  1/70 (1.43%)  0/67 (0.00%) 
Chronic obstructive pulmonary disease  2  1/70 (1.43%)  1/67 (1.49%) 
Non-cardiogenic pulmonary oedema  2  0/70 (0.00%)  1/67 (1.49%) 
Cough * 1  1/70 (1.43%)  0/67 (0.00%) 
Pulmonary mass * 1  1/70 (1.43%)  0/67 (0.00%) 
Surgical and medical procedures     
Arthrodesis * 1  1/70 (1.43%)  0/67 (0.00%) 
Vascular disorders     
Hypotension  2  0/70 (0.00%)  1/67 (1.49%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
2
Term from vocabulary, MedDRA v16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   63/70 (90.00%)   62/67 (92.54%) 
Blood and lymphatic system disorders     
Anaemia * 2  2/70 (2.86%)  1/67 (1.49%) 
Lymphadenopathy * 2  1/70 (1.43%)  0/67 (0.00%) 
Thrombocytopenia * 2  1/70 (1.43%)  1/67 (1.49%) 
Cardiac disorders     
Angina pectoris  1  0/70 (0.00%)  2/67 (2.99%) 
Supraventricular tachycardia  1  1/70 (1.43%)  0/67 (0.00%) 
Tachycardia  1  1/70 (1.43%)  0/67 (0.00%) 
Ear and labyrinth disorders     
Deafness  1  0/70 (0.00%)  1/67 (1.49%) 
Ear pain  1  1/70 (1.43%)  0/67 (0.00%) 
Tinnitus  1  1/70 (1.43%)  1/67 (1.49%) 
Vertigo  1  2/70 (2.86%)  3/67 (4.48%) 
Vertigo positional  1  1/70 (1.43%)  0/67 (0.00%) 
Hearing impaired * 2  1/70 (1.43%)  0/67 (0.00%) 
Hypoacusis * 2  0/70 (0.00%)  1/67 (1.49%) 
Endocrine disorders     
Basedow's disease * 2  0/70 (0.00%)  1/67 (1.49%) 
Hypogonadism * 2  0/70 (0.00%)  1/67 (1.49%) 
Hypothyroidism * 2  0/70 (0.00%)  1/67 (1.49%) 
Eye disorders     
Arteriosclerotic retinopathy  1  1/70 (1.43%)  0/67 (0.00%) 
Chalazion  1  0/70 (0.00%)  1/67 (1.49%) 
Conjunctival hyperaemia  1  1/70 (1.43%)  0/67 (0.00%) 
Eye swelling  1  1/70 (1.43%)  0/67 (0.00%) 
Retinopathy  1  1/70 (1.43%)  0/67 (0.00%) 
Blepharitis * 2  1/70 (1.43%)  0/67 (0.00%) 
Eye disorder * 2  1/70 (1.43%)  0/67 (0.00%) 
Retinopathy hypertensive * 2  0/70 (0.00%)  1/67 (1.49%) 
Endocrine ophthalmopathy * 2  0/70 (0.00%)  1/67 (1.49%) 
Glaucoma * 2  0/70 (0.00%)  1/67 (1.49%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/70 (1.43%)  1/67 (1.49%) 
Abdominal pain  1  1/70 (1.43%)  4/67 (5.97%) 
Abdominal pain upper  1  2/70 (2.86%)  0/67 (0.00%) 
Anal fissure  1  0/70 (0.00%)  1/67 (1.49%) 
Anal haemorrhage  1  0/70 (0.00%)  1/67 (1.49%) 
Constipation  1  2/70 (2.86%)  0/67 (0.00%) 
Diarrhoea  1  8/70 (11.43%)  12/67 (17.91%) 
Dry mouth  1  1/70 (1.43%)  0/67 (0.00%) 
Dyspepsia  1  1/70 (1.43%)  2/67 (2.99%) 
Faecaloma  1  0/70 (0.00%)  1/67 (1.49%) 
Flatulence  1  1/70 (1.43%)  0/67 (0.00%) 
Gastritis  1  0/70 (0.00%)  3/67 (4.48%) 
Gastrointestinal disorder  1  0/70 (0.00%)  1/67 (1.49%) 
Gastrooesophageal reflux disease  1  1/70 (1.43%)  1/67 (1.49%) 
Haemorrhoids  1  3/70 (4.29%)  1/67 (1.49%) 
Hiatus hernia  1  0/70 (0.00%)  1/67 (1.49%) 
Nausea  1  7/70 (10.00%)  9/67 (13.43%) 
Proctitis  1  0/70 (0.00%)  1/67 (1.49%) 
Tongue disorder  1  1/70 (1.43%)  0/67 (0.00%) 
Tooth loss  1  0/70 (0.00%)  1/67 (1.49%) 
Toothache  1  1/70 (1.43%)  7/67 (10.45%) 
Vomiting  1  5/70 (7.14%)  7/67 (10.45%) 
Abdominal distension * 2  1/70 (1.43%)  3/67 (4.48%) 
Abdominal symptom * 2  1/70 (1.43%)  0/67 (0.00%) 
Abdominal tenderness * 2  1/70 (1.43%)  0/67 (0.00%) 
Anorectal discomfort * 2  0/70 (0.00%)  1/67 (1.49%) 
Duodenogastric reflux * 2  0/70 (0.00%)  1/67 (1.49%) 
Dysphagia * 2  1/70 (1.43%)  0/67 (0.00%) 
Erosive oesophagitis * 2  0/70 (0.00%)  1/67 (1.49%) 
Food poisoning * 2  1/70 (1.43%)  0/67 (0.00%) 
Gingival bleeding * 2  1/70 (1.43%)  0/67 (0.00%) 
Gingival swelling * 2  0/70 (0.00%)  1/67 (1.49%) 
Umbilical hernia * 2  0/70 (0.00%)  1/67 (1.49%) 
General disorders     
Asthenia  1  1/70 (1.43%)  3/67 (4.48%) 
Axillary pain  1  0/70 (0.00%)  1/67 (1.49%) 
Chest pain  1  3/70 (4.29%)  3/67 (4.48%) 
Chills  1  1/70 (1.43%)  0/67 (0.00%) 
Facial pain  1  0/70 (0.00%)  1/67 (1.49%) 
Fatigue  1  5/70 (7.14%)  3/67 (4.48%) 
Feeling abnormal  1  1/70 (1.43%)  0/67 (0.00%) 
Influenza like illness  1  3/70 (4.29%)  1/67 (1.49%) 
Malaise  1  0/70 (0.00%)  1/67 (1.49%) 
Mucosal inflammation  1  1/70 (1.43%)  0/67 (0.00%) 
Nodule  1  0/70 (0.00%)  2/67 (2.99%) 
Oedema peripheral  1  2/70 (2.86%)  3/67 (4.48%) 
Pyrexia  1  4/70 (5.71%)  2/67 (2.99%) 
Chest discomfort * 2  0/70 (0.00%)  1/67 (1.49%) 
Inflammation * 2  1/70 (1.43%)  0/67 (0.00%) 
Pain * 2  2/70 (2.86%)  1/67 (1.49%) 
Peripheral swelling * 2  1/70 (1.43%)  1/67 (1.49%) 
Temperature intolerance * 2  0/70 (0.00%)  1/67 (1.49%) 
Hepatobiliary disorders     
Cholestasis  1  0/70 (0.00%)  1/67 (1.49%) 
Hepatic pain  1  0/70 (0.00%)  1/67 (1.49%) 
Hepatomegaly  1  0/70 (0.00%)  2/67 (2.99%) 
Hyperbilirubinaemia  1  0/70 (0.00%)  1/67 (1.49%) 
Hypertransaminasaemia  1  1/70 (1.43%)  0/67 (0.00%) 
Liver disorder  1  1/70 (1.43%)  0/67 (0.00%) 
Hepatic steatosis * 2  0/70 (0.00%)  2/67 (2.99%) 
Immune system disorders     
Seasonal allergy  1  3/70 (4.29%)  0/67 (0.00%) 
Infections and infestations     
Abscess neck  1  0/70 (0.00%)  1/67 (1.49%) 
Acarodermatitis  1  0/70 (0.00%)  1/67 (1.49%) 
Acute tonsillitis  1  1/70 (1.43%)  0/67 (0.00%) 
Bronchitis  1  10/70 (14.29%)  7/67 (10.45%) 
Cellulitis  1  1/70 (1.43%)  1/67 (1.49%) 
Chlamydial infection  1  1/70 (1.43%)  0/67 (0.00%) 
Folliculitis  1  1/70 (1.43%)  1/67 (1.49%) 
Gastritis viral  1  1/70 (1.43%)  0/67 (0.00%) 
Gastroenteritis  1  4/70 (5.71%)  1/67 (1.49%) 
Gingival abscess  1  0/70 (0.00%)  1/67 (1.49%) 
Herpes simplex  1  0/70 (0.00%)  1/67 (1.49%) 
Herpes zoster  1  3/70 (4.29%)  2/67 (2.99%) 
Infection  1  1/70 (1.43%)  0/67 (0.00%) 
Laryngitis  1  1/70 (1.43%)  1/67 (1.49%) 
Latent tuberculosis  1  2/70 (2.86%)  0/67 (0.00%) 
Nasopharyngitis  1  9/70 (12.86%)  6/67 (8.96%) 
Onychomycosis  1  1/70 (1.43%)  2/67 (2.99%) 
Oral candidiasis  1  2/70 (2.86%)  0/67 (0.00%) 
Oral herpes  1  2/70 (2.86%)  1/67 (1.49%) 
Oral infection  1  1/70 (1.43%)  1/67 (1.49%) 
Otitis externa  1  1/70 (1.43%)  2/67 (2.99%) 
Otitis media  1  3/70 (4.29%)  0/67 (0.00%) 
Otitis media fungal  1  0/70 (0.00%)  1/67 (1.49%) 
Penile abscess  1  1/70 (1.43%)  0/67 (0.00%) 
Pharyngitis  1  5/70 (7.14%)  2/67 (2.99%) 
Pneumonia  1  0/70 (0.00%)  5/67 (7.46%) 
Rash pustular  1  1/70 (1.43%)  0/67 (0.00%) 
Respiratory tract infection  1  2/70 (2.86%)  4/67 (5.97%) 
Rhinitis  1  2/70 (2.86%)  0/67 (0.00%) 
Schistosomiasis  1  0/70 (0.00%)  1/67 (1.49%) 
Secondary syphilis  1  0/70 (0.00%)  1/67 (1.49%) 
Sinusitis  1  5/70 (7.14%)  4/67 (5.97%) 
Subcutaneous abscess  1  2/70 (2.86%)  3/67 (4.48%) 
Syphilis  1  3/70 (4.29%)  8/67 (11.94%) 
Tinea infection  1  1/70 (1.43%)  1/67 (1.49%) 
Tonsillitis  1  1/70 (1.43%)  0/67 (0.00%) 
Tooth abscess  1  3/70 (4.29%)  0/67 (0.00%) 
Tooth infection  1  4/70 (5.71%)  1/67 (1.49%) 
Upper respiratory tract infection  1  11/70 (15.71%)  11/67 (16.42%) 
Urethritis  1  0/70 (0.00%)  2/67 (2.99%) 
Urinary tract infection  1  3/70 (4.29%)  5/67 (7.46%) 
Viral infection  1  6/70 (8.57%)  4/67 (5.97%) 
Acute sinusitis * 2  0/70 (0.00%)  1/67 (1.49%) 
Body tinea * 2  0/70 (0.00%)  1/67 (1.49%) 
Carbuncle * 2  1/70 (1.43%)  0/67 (0.00%) 
Chikungunya virus infection * 2  0/70 (0.00%)  1/67 (1.49%) 
Conjunctivitis * 2  1/70 (1.43%)  1/67 (1.49%) 
Ear infection * 2  1/70 (1.43%)  1/67 (1.49%) 
Fungal skin infection * 2  1/70 (1.43%)  1/67 (1.49%) 
Furuncle * 2  1/70 (1.43%)  0/67 (0.00%) 
Gastroenteritis viral * 2  1/70 (1.43%)  0/67 (0.00%) 
Genital herpes simplex * 2  0/70 (0.00%)  1/67 (1.49%) 
Gingivitis * 2  1/70 (1.43%)  1/67 (1.49%) 
Groin abscess * 2  0/70 (0.00%)  2/67 (2.99%) 
Herpes virus infection * 2  1/70 (1.43%)  0/67 (0.00%) 
Influenza * 2  1/70 (1.43%)  3/67 (4.48%) 
Lower respiratory tract infection * 2  0/70 (0.00%)  1/67 (1.49%) 
Mastitis * 2  1/70 (1.43%)  0/67 (0.00%) 
Muscle abscess * 2  0/70 (0.00%)  1/67 (1.49%) 
Oesophageal candidiasis * 2  0/70 (0.00%)  1/67 (1.49%) 
Post procedural infection * 2  0/70 (0.00%)  1/67 (1.49%) 
Proctitis chlamydial * 2  0/70 (0.00%)  1/67 (1.49%) 
Streptococcal infection * 2  1/70 (1.43%)  0/67 (0.00%) 
Vulvovaginal mycotic infection * 2  1/70 (1.43%)  0/67 (0.00%) 
Epididymitis * 2  0/70 (0.00%)  1/67 (1.49%) 
Injury, poisoning and procedural complications     
Arthropod sting  1  0/70 (0.00%)  2/67 (2.99%) 
Contusion  1  2/70 (2.86%)  2/67 (2.99%) 
Exposure to communicable disease  1  1/70 (1.43%)  0/67 (0.00%) 
Fibula fracture  1  0/70 (0.00%)  1/67 (1.49%) 
Hand fracture  1  2/70 (2.86%)  0/67 (0.00%) 
Joint injury  1  0/70 (0.00%)  1/67 (1.49%) 
Laceration  1  1/70 (1.43%)  3/67 (4.48%) 
Ligament sprain  1  2/70 (2.86%)  2/67 (2.99%) 
Limb injury  1  0/70 (0.00%)  1/67 (1.49%) 
Muscle strain  1  0/70 (0.00%)  3/67 (4.48%) 
Procedural pain  1  1/70 (1.43%)  0/67 (0.00%) 
Radius fracture  1  0/70 (0.00%)  1/67 (1.49%) 
Spinal compression fracture  1  0/70 (0.00%)  1/67 (1.49%) 
Bone contusion * 2  0/70 (0.00%)  1/67 (1.49%) 
Epicondylitis * 2  0/70 (0.00%)  1/67 (1.49%) 
Fall * 2  0/70 (0.00%)  1/67 (1.49%) 
Humerus fracture * 2  1/70 (1.43%)  0/67 (0.00%) 
Lower limb fracture * 2  0/70 (0.00%)  1/67 (1.49%) 
Muscle injury * 2  0/70 (0.00%)  1/67 (1.49%) 
Overdose * 2  0/70 (0.00%)  1/67 (1.49%) 
Gastrointestinal injury * 2  1/70 (1.43%)  0/67 (0.00%) 
Wound * 2  2/70 (2.86%)  0/67 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/70 (1.43%)  4/67 (5.97%) 
Aspartate aminotransferase increased  1  0/70 (0.00%)  2/67 (2.99%) 
Blood creatinine increased  1  1/70 (1.43%)  1/67 (1.49%) 
Blood pressure increased  1  1/70 (1.43%)  0/67 (0.00%) 
Gamma-glutamyltransferase increased  1  0/70 (0.00%)  1/67 (1.49%) 
Intraocular pressure increased  1  0/70 (0.00%)  1/67 (1.49%) 
Lipase increased  1  0/70 (0.00%)  3/67 (4.48%) 
Transaminases increased  1  1/70 (1.43%)  0/67 (0.00%) 
Viral load increased  1  0/70 (0.00%)  1/67 (1.49%) 
Amylase increased * 2  0/70 (0.00%)  2/67 (2.99%) 
Blood creatine phosphokinase increased * 2  0/70 (0.00%)  1/67 (1.49%) 
Hepatic enzyme increased * 2  0/70 (0.00%)  1/67 (1.49%) 
Liver function test abnormal * 2  0/70 (0.00%)  1/67 (1.49%) 
Weight decreased * 2  1/70 (1.43%)  4/67 (5.97%) 
Anal pap smear abnormal * 2  0/70 (0.00%)  1/67 (1.49%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/70 (0.00%)  3/67 (4.48%) 
Dyslipidaemia  1  0/70 (0.00%)  2/67 (2.99%) 
Gout  1  0/70 (0.00%)  2/67 (2.99%) 
Hypercholesterolaemia  1  1/70 (1.43%)  1/67 (1.49%) 
Hypertriglyceridaemia  1  2/70 (2.86%)  0/67 (0.00%) 
Obesity  1  0/70 (0.00%)  1/67 (1.49%) 
Hyperglycaemia * 2  1/70 (1.43%)  0/67 (0.00%) 
Hypophosphataemia * 2  1/70 (1.43%)  0/67 (0.00%) 
Vitamin D deficiency * 2  2/70 (2.86%)  3/67 (4.48%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/70 (10.00%)  6/67 (8.96%) 
Back pain  1  4/70 (5.71%)  10/67 (14.93%) 
Bursitis  1  0/70 (0.00%)  3/67 (4.48%) 
Flank pain  1  1/70 (1.43%)  1/67 (1.49%) 
Intervertebral disc protrusion  1  0/70 (0.00%)  1/67 (1.49%) 
Joint effusion  1  0/70 (0.00%)  1/67 (1.49%) 
Muscle spasms  1  1/70 (1.43%)  0/67 (0.00%) 
Muscular weakness  1  2/70 (2.86%)  0/67 (0.00%) 
Musculoskeletal chest pain  1  0/70 (0.00%)  2/67 (2.99%) 
Musculoskeletal pain  1  0/70 (0.00%)  4/67 (5.97%) 
Musculoskeletal stiffness  1  0/70 (0.00%)  1/67 (1.49%) 
Myalgia  1  2/70 (2.86%)  2/67 (2.99%) 
Pain in extremity  1  3/70 (4.29%)  7/67 (10.45%) 
Pain in jaw  1  1/70 (1.43%)  0/67 (0.00%) 
Rotator cuff syndrome  1  0/70 (0.00%)  1/67 (1.49%) 
Spinal osteoarthritis  1  1/70 (1.43%)  0/67 (0.00%) 
Arthritis * 2  1/70 (1.43%)  1/67 (1.49%) 
Costochondritis * 2  1/70 (1.43%)  0/67 (0.00%) 
Gouty arthritis * 2  1/70 (1.43%)  0/67 (0.00%) 
Intervertebral disc disorder * 2  1/70 (1.43%)  0/67 (0.00%) 
Musculoskeletal discomfort * 2  1/70 (1.43%)  0/67 (0.00%) 
Neck pain * 2  0/70 (0.00%)  1/67 (1.49%) 
Osteopenia * 2  1/70 (1.43%)  0/67 (0.00%) 
Spondylitis * 2  0/70 (0.00%)  2/67 (2.99%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  0/70 (0.00%)  1/67 (1.49%) 
Skin papilloma  1  0/70 (0.00%)  1/67 (1.49%) 
Lipoma * 2  1/70 (1.43%)  0/67 (0.00%) 
Oral papilloma * 2  1/70 (1.43%)  0/67 (0.00%) 
Nervous system disorders     
Ageusia  1  1/70 (1.43%)  0/67 (0.00%) 
Amnesia  1  1/70 (1.43%)  1/67 (1.49%) 
Burning sensation  1  0/70 (0.00%)  1/67 (1.49%) 
Carpal tunnel syndrome  1  1/70 (1.43%)  0/67 (0.00%) 
Cervicobrachial syndrome  1  0/70 (0.00%)  1/67 (1.49%) 
Complex regional pain syndrome  1  1/70 (1.43%)  0/67 (0.00%) 
Dizziness  1  4/70 (5.71%)  6/67 (8.96%) 
Dysaesthesia  1  2/70 (2.86%)  0/67 (0.00%) 
Dysgeusia  1  0/70 (0.00%)  1/67 (1.49%) 
Headache  1  6/70 (8.57%)  5/67 (7.46%) 
Hypertonia  1  1/70 (1.43%)  0/67 (0.00%) 
Hypoaesthesia  1  1/70 (1.43%)  1/67 (1.49%) 
Intercostal neuralgia  1  1/70 (1.43%)  0/67 (0.00%) 
Migraine  1  3/70 (4.29%)  3/67 (4.48%) 
Sciatica  1  1/70 (1.43%)  2/67 (2.99%) 
Somnolence  1  0/70 (0.00%)  2/67 (2.99%) 
Aphasia * 2  1/70 (1.43%)  0/67 (0.00%) 
Disturbance in attention * 2  0/70 (0.00%)  1/67 (1.49%) 
Dyskinesia * 2  0/70 (0.00%)  1/67 (1.49%) 
Epilepsy * 2  1/70 (1.43%)  0/67 (0.00%) 
Hemiparesis * 2  1/70 (1.43%)  0/67 (0.00%) 
Loss of consciousness * 2  0/70 (0.00%)  1/67 (1.49%) 
Neuropathy peripheral * 2  1/70 (1.43%)  0/67 (0.00%) 
VIIth nerve paralysis * 2  0/70 (0.00%)  1/67 (1.49%) 
Psychiatric disorders     
Abnormal dreams  1  0/70 (0.00%)  1/67 (1.49%) 
Anxiety  1  0/70 (0.00%)  4/67 (5.97%) 
Depression  1  5/70 (7.14%)  4/67 (5.97%) 
Dissociation  1  1/70 (1.43%)  0/67 (0.00%) 
Insomnia  1  5/70 (7.14%)  6/67 (8.96%) 
Nightmare  1  0/70 (0.00%)  1/67 (1.49%) 
Sleep disorder  1  1/70 (1.43%)  2/67 (2.99%) 
Alcohol abuse * 2  0/70 (0.00%)  1/67 (1.49%) 
Alcoholism * 2  0/70 (0.00%)  1/67 (1.49%) 
Hallucination, auditory * 2  0/70 (0.00%)  1/67 (1.49%) 
Paranoia * 2  0/70 (0.00%)  1/67 (1.49%) 
Substance abuse * 2  1/70 (1.43%)  1/67 (1.49%) 
Suicidal ideation * 2  1/70 (1.43%)  0/67 (0.00%) 
Renal and urinary disorders     
Dysuria  1  2/70 (2.86%)  2/67 (2.99%) 
Haematuria  1  0/70 (0.00%)  1/67 (1.49%) 
Leukocyturia  1  1/70 (1.43%)  1/67 (1.49%) 
Micturition urgency  1  0/70 (0.00%)  1/67 (1.49%) 
Nephrolithiasis  1  1/70 (1.43%)  2/67 (2.99%) 
Renal cyst  1  1/70 (1.43%)  0/67 (0.00%) 
Urinary hesitation  1  1/70 (1.43%)  0/67 (0.00%) 
Bladder prolapse * 2  0/70 (0.00%)  1/67 (1.49%) 
Pollakiuria * 2  1/70 (1.43%)  1/67 (1.49%) 
Polyuria * 2  0/70 (0.00%)  1/67 (1.49%) 
Urethral discharge * 2  0/70 (0.00%)  1/67 (1.49%) 
Urinary incontinence * 2  0/70 (0.00%)  1/67 (1.49%) 
Reproductive system and breast disorders     
Breast mass  1  0/70 (0.00%)  2/67 (2.99%) 
Erectile dysfunction  1  1/70 (1.43%)  0/67 (0.00%) 
Genital rash  1  0/70 (0.00%)  1/67 (1.49%) 
Prostatitis  1  1/70 (1.43%)  1/67 (1.49%) 
Pruritus genital  1  0/70 (0.00%)  1/67 (1.49%) 
Testicular pain  1  0/70 (0.00%)  1/67 (1.49%) 
Genital lesion * 2  0/70 (0.00%)  1/67 (1.49%) 
Gynaecomastia * 2  0/70 (0.00%)  1/67 (1.49%) 
Prostatic disorder * 2  0/70 (0.00%)  1/67 (1.49%) 
Vulvovaginal pruritus * 2  0/70 (0.00%)  1/67 (1.49%) 
Vulvovaginal swelling * 2  0/70 (0.00%)  1/67 (1.49%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/70 (1.43%)  1/67 (1.49%) 
Cough  1  9/70 (12.86%)  2/67 (2.99%) 
Dyspnoea  1  1/70 (1.43%)  2/67 (2.99%) 
Haemoptysis  1  0/70 (0.00%)  1/67 (1.49%) 
Nasal congestion  1  0/70 (0.00%)  1/67 (1.49%) 
Oropharyngeal pain  1  4/70 (5.71%)  2/67 (2.99%) 
Pharyngeal erythema  1  2/70 (2.86%)  0/67 (0.00%) 
Productive cough  1  0/70 (0.00%)  1/67 (1.49%) 
Sinus congestion  1  0/70 (0.00%)  1/67 (1.49%) 
Sneezing  1  0/70 (0.00%)  1/67 (1.49%) 
Bronchial hyperreactivity * 2  1/70 (1.43%)  0/67 (0.00%) 
Chronic obstructive pulmonary disease * 2  0/70 (0.00%)  1/67 (1.49%) 
Dry throat * 2  1/70 (1.43%)  0/67 (0.00%) 
Epistaxis * 2  0/70 (0.00%)  1/67 (1.49%) 
Pulmonary hypertension * 2  0/70 (0.00%)  1/67 (1.49%) 
Pulmonary mass * 2  1/70 (1.43%)  0/67 (0.00%) 
Sinus disorder * 2  0/70 (0.00%)  1/67 (1.49%) 
Throat irritation * 2  0/70 (0.00%)  1/67 (1.49%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/70 (1.43%)  1/67 (1.49%) 
Alopecia  1  1/70 (1.43%)  2/67 (2.99%) 
Dermatitis  1  2/70 (2.86%)  1/67 (1.49%) 
Hyperhidrosis  1  0/70 (0.00%)  1/67 (1.49%) 
Night sweats  1  3/70 (4.29%)  1/67 (1.49%) 
Pruritus  1  4/70 (5.71%)  6/67 (8.96%) 
Rash  1  5/70 (7.14%)  3/67 (4.48%) 
Rash maculo-papular  1  1/70 (1.43%)  0/67 (0.00%) 
Rosacea  1  0/70 (0.00%)  1/67 (1.49%) 
Seborrhoeic dermatitis  1  1/70 (1.43%)  0/67 (0.00%) 
Skin lesion  1  2/70 (2.86%)  3/67 (4.48%) 
Skin mass  1  0/70 (0.00%)  1/67 (1.49%) 
Actinic keratosis * 2  0/70 (0.00%)  1/67 (1.49%) 
Dermatitis allergic * 2  1/70 (1.43%)  1/67 (1.49%) 
Dermatitis allergic * 2  1/70 (1.43%)  0/67 (0.00%) 
Dermatitis contact * 2  1/70 (1.43%)  0/67 (0.00%) 
Dry skin * 2  1/70 (1.43%)  1/67 (1.49%) 
Dyshidrotic eczema * 2  1/70 (1.43%)  0/67 (0.00%) 
Eczema * 2  1/70 (1.43%)  1/67 (1.49%) 
Erythema * 2  0/70 (0.00%)  1/67 (1.49%) 
Onycholysis * 2  1/70 (1.43%)  0/67 (0.00%) 
Rash papular * 2  1/70 (1.43%)  0/67 (0.00%) 
Skin fissures * 2  1/70 (1.43%)  0/67 (0.00%) 
Skin plaque * 2  0/70 (0.00%)  1/67 (1.49%) 
Skin ulcer * 2  0/70 (0.00%)  1/67 (1.49%) 
Spider naevus * 2  1/70 (1.43%)  0/67 (0.00%) 
Swelling face * 2  1/70 (1.43%)  0/67 (0.00%) 
Rash pruritic * 2  0/70 (0.00%)  1/67 (1.49%) 
Social circumstances     
Menopause * 2  1/70 (1.43%)  0/67 (0.00%) 
Surgical and medical procedures     
Abdominal hernia repair  1  0/70 (0.00%)  1/67 (1.49%) 
Skin lesion excision  1  1/70 (1.43%)  0/67 (0.00%) 
Tooth extraction  1  0/70 (0.00%)  1/67 (1.49%) 
Cataract operation * 2  0/70 (0.00%)  1/67 (1.49%) 
Vascular disorders     
Haematoma  1  0/70 (0.00%)  1/67 (1.49%) 
Hot flush  1  0/70 (0.00%)  2/67 (2.99%) 
Hypertension  1  4/70 (5.71%)  3/67 (4.48%) 
Hypotension  1  1/70 (1.43%)  1/67 (1.49%) 
Varicose vein  1  1/70 (1.43%)  1/67 (1.49%) 
Deep vein thrombosis * 2  0/70 (0.00%)  2/67 (2.99%) 
Peripheral venous disease * 2  0/70 (0.00%)  1/67 (1.49%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.0
2
Term from vocabulary, MedDRA v17.0
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01327547     History of Changes
Other Study ID Numbers: A4001098
2010-021994-35 ( EudraCT Number )
First Submitted: March 22, 2011
First Posted: April 1, 2011
Results First Submitted: April 9, 2014
Results First Posted: November 14, 2014
Last Update Posted: December 6, 2017