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Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects (MOTIVATE 2)

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ClinicalTrials.gov Identifier: NCT00098722
Recruitment Status : Completed
First Posted : December 8, 2004
Results First Posted : May 16, 2012
Last Update Posted : May 16, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Maraviroc (UK-427,857)
Drug: optimized background therapy
Enrollment 474

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc QD, Double Blind Maraviroc BID, Double Blind Placebo, Double Blind Maraviroc BID, Open Label In Study-off Drug (ISOD), Open Label Maraviroc BID, Observation Phase In Study-off Drug (ISOD), Observation Phase
Hide Arm/Group Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning. Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase. Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase. Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase. Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
Period Title: Double Blind Phase
Started 186 194 94 0 0 0 0
Treated 182 191 91 0 0 0 0
Completed 0 0 0 0 0 0 0
Not Completed 186 194 94 0 0 0 0
Reason Not Completed
Adverse Event             7             7             3             0             0             0             0
Death             2             5             0             0             0             0             0
Lack of Efficacy             21             23             15             0             0             0             0
Participant defaulted             16             11             9             0             0             0             0
Pregnancy             1             0             0             0             0             0             0
Randomized, not treated             4             3             3             0             0             0             0
Ongoing at cut-off date             128             137             57             0             0             0             0
Other             7             8             7             0             0             0             0
Period Title: Open Label Phase
Started 0 0 0 272 50 0 0
Completed 0 0 0 0 0 0 0
Not Completed 0 0 0 272 50 0 0
Reason Not Completed
Adverse Event             0             0             0             5             0             0             0
Death             0             0             0             2             0             0             0
Lack of Efficacy             0             0             0             8             0             0             0
Pregnancy             0             0             0             1             0             0             0
Participant defaulted             0             0             0             18             0             0             0
Ongoing at cut-off date             0             0             0             220             50             0             0
Other             0             0             0             18             0             0             0
Period Title: Observation Phase
Started 0 0 0 0 0 205 65
Completed 0 0 0 0 0 160 48
Not Completed 0 0 0 0 0 45 17
Reason Not Completed
Death             0             0             0             0             0             5             3
Lack of Efficacy             0             0             0             0             0             2             0
Participant defaulted             0             0             0             0             0             17             4
Other             0             0             0             0             0             21             10
Arm/Group Title Maraviroc QD Maraviroc BID Placebo Total
Hide Arm/Group Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning. Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Total of all reporting groups
Overall Number of Baseline Participants 182 191 91 464
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 182 participants 191 participants 91 participants 464 participants
Less than 18 years 1 0 0 1
18 to 24 years 1 1 0 2
25 to 34 years 8 9 6 23
35 to 44 years 85 71 40 196
45 to 54 years 63 70 32 165
55 to 64 years 19 37 11 67
Greater than or equal to 65 years 5 3 2 10
[1]
Measure Description: Out of a total of 474 participants, data for baseline measure (age) was available for 464 participants who were treated.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 191 participants 91 participants 464 participants
Female
29
  15.9%
21
  11.0%
12
  13.2%
62
  13.4%
Male
153
  84.1%
170
  89.0%
79
  86.8%
402
  86.6%
[1]
Measure Description: Out of a total of 474 participants, data for baseline measure (gender) was available for 464 participants who were treated.
1.Primary Outcome
Title Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Hide Description Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Mean (Standard Deviation)
Unit of Measure: log10 copies/milliliter(log10 copies/mL)
4.873  (0.6641) 4.840  (0.6205) 4.886  (0.6957)
2.Primary Outcome
Title Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Hide Description Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
-1.950  (0.1054) -1.971  (0.1026) -0.929  (0.1473)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.021
Confidence Interval (2-Sided) 97.5%
-1.426 to -0.616
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1802
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.042
Confidence Interval (2-Sided) 97.5%
-1.444 to -0.640
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1786
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Hide Description Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
-1.718  (0.1086) -1.865  (0.1057) -0.757  (0.1518)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.961
Confidence Interval (2-Sided) 97.5%
-1.379 to -0.544
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1856
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.109
Confidence Interval (2-Sided) 97.5%
-1.523 to -0.695
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1840
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Hide Description [Not Specified]
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 55.49 61.26 23.08
Week 48 52.75 54.97 23.08
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than [<] 100,000 or greater than or equal to [>=] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (>) 1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.59
Confidence Interval (2-Sided) 95%
2.56 to 8.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.01
Confidence Interval (2-Sided) 95%
3.35 to 10.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.03
Confidence Interval (2-Sided) 95%
2.25 to 7.20
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.41
Confidence Interval (2-Sided) 95%
2.47 to 7.85
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
Hide Description [Not Specified]
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 69.78 72.25 37.36
Week 48 60.99 65.97 31.87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.69
Confidence Interval (2-Sided) 95%
2.72 to 8.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.01
Confidence Interval (2-Sided) 95%
2.91 to 8.62
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.67
Confidence Interval (2-Sided) 95%
2.13 to 6.32
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.64
Confidence Interval (2-Sided) 95%
2.69 to 8.02
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
Hide Description [Not Specified]
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 66.48 69.63 30.77
Week 48 58.79 63.35 27.47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.58
Confidence Interval (2-Sided) 95%
2.64 to 7.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.42
Confidence Interval (2-Sided) 95%
3.13 to 9.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.01
Confidence Interval (2-Sided) 95%
2.29 to 7.00
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.08
Confidence Interval (2-Sided) 95%
2.91 to 8.89
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Hide Description [Not Specified]
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 45.60 40.84 20.88
Week 48 45.05 44.50 17.58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.55
Confidence Interval (2-Sided) 95%
1.95 to 6.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.88
Confidence Interval (2-Sided) 95%
1.59 to 5.23
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.23
Confidence Interval (2-Sided) 95%
2.26 to 7.92
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.10
Confidence Interval (2-Sided) 95%
2.20 to 7.64
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Hide Description Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 90
Mean (Standard Deviation)
Unit of Measure: cells per microliter (cells/μL)
CD4 206.0  (171.99) 204.9  (149.21) 198.5  (140.39)
CD8 994.6  (658.03) 996.9  (576.97) 952.3  (598.19)
9.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24 and 48
Hide Description Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 180 185 90
Least Squares Mean (Standard Error)
Unit of Measure: cells/μL
Week 24 111.72  (7.821) 101.89  (7.684) 63.78  (10.929)
Week 48 121.49  (8.651) 127.80  (8.499) 69.34  (12.088)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 47.94
Confidence Interval (2-Sided) 95%
21.64 to 74.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 13.383
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 38.12
Confidence Interval (2-Sided) 95%
11.96 to 64.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 13.313
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 52.15
Confidence Interval (2-Sided) 95%
23.06 to 81.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.803
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 58.46
Confidence Interval (2-Sided) 95%
29.53 to 87.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.725
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in CD8 Cell Count at Week 24 and 48
Hide Description Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Time Frame Week 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 180 185 90
Least Squares Mean (Standard Error)
Unit of Measure: cells/μL
Week 24 340.74  (41.601) 255.40  (40.873) 122.18  (58.150)
Week 48 241.43  (33.789) 244.75  (33.198) 104.51  (47.231)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 218.57
Confidence Interval (2-Sided) 95%
78.59 to 358.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 71.225
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 133.22
Confidence Interval (2-Sided) 95%
-6.03 to 272.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 70.855
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 136.93
Confidence Interval (2-Sided) 95%
23.24 to 250.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 57.850
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 140.25
Confidence Interval (2-Sided) 95%
27.15 to 253.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 57.550
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to Virological Failure
Hide Description Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Median (95% Confidence Interval)
Unit of Measure: days
345.00 [1] 
(197.00 to NA)
361.00 [1] 
(361.00 to NA)
0.00 [2] 
(NA to NA)
[1]
Upper limit of CI was not estimable because the empirical distribution rendered the algorithmic formula non-calculable.
[2]
Data was not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.29 to 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.23 to 0.46
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
Hide Description TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Time Frame Baseline to Week 24 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/mL
Week 24 -1.748  (0.0897) -1.755  (0.0873) -0.872  (0.1254)
Week 48 -1.603  (0.0994) -1.781  (0.0968) -0.748  (0.1390)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.876
Confidence Interval (2-Sided) 95%
-1.177 to -0.575
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1534
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.882
Confidence Interval (2-Sided) 95%
-1.181 to -0.584
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1521
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc QD, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.855
Confidence Interval (2-Sided) 95%
-1.189 to -0.521
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1700
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc BID, Placebo
Comments Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.033
Confidence Interval (2-Sided) 95%
-1.364 to -0.701
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1685
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Hide Description Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Time Frame Screening
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomized participants who had taken at least one dose of the study medication.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 182 191 91
Measure Type: Number
Unit of Measure: participants
GSS: 0 39 43 20
GSS: 1 64 58 24
GSS: 2 25 32 20
GSS: greater than or equal to 3 52 57 25
GSS: missing 2 1 2
PSS: 0 20 26 12
PSS: 1 46 42 20
PSS: 2 42 38 23
PSS: greater than or equal to 3 71 84 34
PSS: missing 3 1 2
14.Secondary Outcome
Title Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Hide Description Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Time Frame Screening and time of failure through Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 27 31 44
Measure Type: Number
Unit of Measure: participants
Change in GSS by less than -3 (n= 22, 25, 40) 0 1 0
Change in GSS by -3 (n= 22, 25, 40) 0 0 0
Change in GSS by -2 (n= 22, 25, 40) 0 0 1
Change in GSS by -1 (n= 22, 25, 40) 9 6 15
Change in GSS by 0 (n= 22, 25, 40) 13 15 22
Change in GSS by 1 (n= 22, 25, 40) 0 3 1
Change in GSS by 2 (n= 22, 25, 40) 0 0 1
Change in GSS by 3 (n= 22, 25, 40) 0 0 0
Change in GSS by greater than 3 (n= 22, 25, 40) 0 0 0
Change in PSS by less than -3 (n= 22, 24, 40) 0 0 0
Change in PSS by -3 (n= 22, 24, 40) 1 0 2
Change in PSS by -2 (n= 22, 24, 40) 2 3 3
Change in PSS by -1 (n= 22, 24, 40) 8 8 16
Change in PSS by 0 (n= 22, 24, 40) 10 13 18
Change in PSS by 1 (n= 22, 24, 40) 1 0 1
Change in PSS by 2 (n= 22, 24, 40) 0 0 0
Change in PSS by 3 (n= 22, 24, 40) 0 0 0
Change in PSS by greater than 3 (n= 22, 24, 40) 0 0 0
15.Secondary Outcome
Title Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48
Hide Description Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Time Frame Screening and time of failure through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 41 38 49
Measure Type: Number
Unit of Measure: participants
Change in GSS by less than -3 (n= 35, 33, 46) 0 1 0
Change in GSS by -3 (n= 35, 33, 46) 0 0 0
Change in GSS by -2 (n= 35, 33, 46) 0 0 2
Change in GSS by -1 (n= 35, 33, 46) 12 6 17
Change in GSS by 0 (n= 35, 33, 46) 23 22 24
Change in GSS by 1 (n= 35, 33, 46) 0 4 2
Change in GSS by 2 (n= 35, 33, 46) 0 0 1
Change in GSS by 3 (n= 35, 33, 46) 0 0 0
Change in GSS by greater than 3 (n= 35, 33, 46) 0 0 0
Change in PSS by less than -3 (n= 35, 32, 46) 0 0 0
Change in PSS by -3 (n= 35, 32, 46) 1 0 3
Change in PSS by -2 (n= 35, 32, 46) 3 3 4
Change in PSS by -1 (n= 35, 32, 46) 13 9 18
Change in PSS by 0 (n= 35, 32, 46) 16 19 19
Change in PSS by 1 (n= 35, 32, 46) 2 0 2
Change in PSS by 2 (n= 35, 32, 46) 0 1 0
Change in PSS by 3 (n= 35, 32, 46) 0 0 0
Change in PSS by greater than 3 (n= 35, 32, 46) 0 0 0
16.Secondary Outcome
Title Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Hide Description Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
Time Frame Baseline and time of failure through Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 26 31 44
Measure Type: Number
Unit of Measure: participants
Baseline: R5; Treatment failure: R5 8 7 36
Baseline: R5; Treatment failure: X4 2 2 0
Baseline: R5; Treatment failure: DM 5 6 3
Baseline: R5; Treatment failure: NR/NP 6 5 2
Baseline: DM; Treatment failure: R5 1 0 2
Baseline: DM; Treatment failure: X4 0 2 0
Baseline: DM; Treatment failure: DM 3 7 0
Baseline: DM; Treatment failure: NR/NP 0 1 0
17.Secondary Outcome
Title Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Hide Description Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
Time Frame Baseline and time of failure through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 41 38 49
Measure Type: Number
Unit of Measure: participants
Baseline: R5; Treatment failure: R5 17 9 40
Baseline: R5; Treatment failure: X4 2 2 0
Baseline: R5; Treatment failure: DM 8 10 3
Baseline: R5; Treatment failure: NR/NP 6 6 2
Baseline: DM; Treatment failure: R5 1 0 3
Baseline: DM; Treatment failure: X4 0 2 0
Baseline: DM; Treatment failure: DM 3 7 0
Baseline: DM; Treatment failure: NR/NP 0 1 0
18.Secondary Outcome
Title Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Hide Description Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
Time Frame Baseline, Week 24 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.
Arm/Group Title Maraviroc QD Maraviroc BID Placebo
Hide Arm/Group Description:
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Overall Number of Participants Analyzed 180 185 91
Mean (Standard Deviation)
Unit of Measure: log10copies/mL
Week 24; Screening OSS 0 (n= 22, 29, 16) -1.721  (1.0477) -1.231  (1.2924) -0.264  (0.8979)
Week 24; Screening OSS 1 (n= 54, 48, 23) -1.822  (1.0244) -2.051  (1.1860) -0.651  (0.9756)
Week 24; Screening OSS 2 (n= 37, 39, 21) -2.145  (1.4052) -2.515  (0.8209) -0.611  (0.9732)
Week 24; Screening OSS >=3 (n= 64, 68, 29) -2.655  (1.1364) -2.530  (1.2694) -2.109  (1.3495)
Week 24; Screening OSS= Missing (n= 3, 1, 2) -2.642  (0.9282) -0.544 [1]   (NA) -1.169  (2.1350)
Week 48; Screening OSS 0 (n= 22, 29, 16) -1.745  (1.2354) -1.290  (1.2978) -0.249  (0.8727)
Week 48; Screening OSS 1 (n= 54, 48, 23) -1.678  (1.2115) -1.899  (1.1966) -0.594  (0.9454)
Week 48; Screening OSS 2 (n= 38, 39, 21) -2.207  (1.3866) -2.565  (0.8734) -0.591  (0.9309)
Week 48; Screening OSS >=3 (n= 63, 68, 29) -2.448  (1.2477) -2.426  (1.2977) -1.942  (1.4167)
Week 48; Screening OSS= Missing (n= 3, 1, 2) -2.795  (0.5079) -0.833 [1]   (NA) -1.105  (2.0447)
[1]
Data was not estimable since only 1 participant was evaluable.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a 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 QD Maraviroc BID Placebo Maraviroc BID, Open Label In Study-off Drug, Open Label Maraviroc BID, Observation Phase In Study-off Drug, Observation Phase
Hide Arm/Group Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning. Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase. Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase. Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase. Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
All-Cause Mortality
Maraviroc QD Maraviroc BID Placebo Maraviroc BID, Open Label In Study-off Drug, Open Label Maraviroc BID, Observation Phase In Study-off Drug, Observation Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc QD Maraviroc BID Placebo Maraviroc BID, Open Label In Study-off Drug, Open Label Maraviroc BID, Observation Phase In Study-off Drug, Observation Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/182 (21.98%)   46/191 (24.08%)   16/91 (17.58%)   28/272 (10.29%)   0/50 (0.00%)   0/205 (0.00%)   0/65 (0.00%) 
Blood and lymphatic system disorders               
Anaemia * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  2/272 (0.74%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Febrile neutropenia * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Haemolytic anaemia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lymphadenopathy * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Neutropenia * 1  1/182 (0.55%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pancytopenia * 1  0/182 (0.00%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Thrombocytopenia * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cardiac disorders               
Aortic valve disease * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Arrhythmia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cardiac failure acute * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cardio-respiratory arrest * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Coronary artery occlusion * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Myocardial infarction * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Supraventricular tachyarrhythmia * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Endocrine disorders               
Hypothyroidism * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Eye disorders               
Retinal detachment * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Gastrointestinal disorders               
Abdominal pain * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Diarrhoea * 1  2/182 (1.10%)  2/191 (1.05%)  1/91 (1.10%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Dysphagia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Inguinal hernia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Nausea * 1  3/182 (1.65%)  2/191 (1.05%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Proctitis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Rectal ulcer * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Vomiting * 1  3/182 (1.65%)  3/191 (1.57%)  2/91 (2.20%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Reflux oesophagitis * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
General disorders               
Chest pain * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Fatigue * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hyperthermia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Oedema peripheral * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pyrexia * 1  1/182 (0.55%)  2/191 (1.05%)  3/91 (3.30%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Mucosal erosion * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Sudden death * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hepatobiliary disorders               
Bile duct stone * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cholecystitis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hepatic failure * 1  0/182 (0.00%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Jaundice cholestatic * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Immune system disorders               
Drug hypersensitivity * 1  1/182 (0.55%)  1/191 (0.52%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Immune reconstitution syndrome * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Infections and infestations               
Anogenital warts * 1  2/182 (1.10%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Appendicitis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Aspergillosis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Bronchitis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Bronchopneumonia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cellulitis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Cystitis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Endocarditis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Gastroenteritis * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Genital herpes * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Genitourinary tract infection * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Herpes simplex * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Herpes virus infection * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Herpes zoster * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Herpes zoster disseminated * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Klebsiella sepsis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Laryngitis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Liver abscess * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lobar pneumonia * 1  1/182 (0.55%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lung infection * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Malaria * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Mycobacterial infection * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Mycobacterium avium complex infection * 1  0/182 (0.00%)  1/191 (0.52%)  1/91 (1.10%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Mycoplasma infection * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Neurosyphilis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Oesophageal candidiasis * 1  1/182 (0.55%)  1/191 (0.52%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Oral candidiasis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pneumococcal sepsis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pneumocystis jiroveci pneumonia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pneumonia * 1  2/182 (1.10%)  5/191 (2.62%)  1/91 (1.10%)  3/272 (1.10%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pneumonia bacterial * 1  1/182 (0.55%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pneumonia cytomegaloviral * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Progressive multifocal leukoencephalopathy * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pyothorax * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Respiratory tract infection * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Sepsis * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Septic shock * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Sinusitis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Syphilis * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Tuberculosis * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Upper respiratory tract infection * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Urinary tract infection * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Injury, poisoning and procedural complications               
Post procedural discomfort * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Investigations               
Alanine aminotransferase increased * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Aspartate aminotransferase increased * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Blood bilirubin increased * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Blood creatine phosphokinase increased * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hepatic enzyme increased * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Liver function test abnormal * 1  2/182 (1.10%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Weight decreased * 1  1/182 (0.55%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  1/182 (0.55%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Dehydration * 1  0/182 (0.00%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Diabetes mellitus * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Gout * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain * 1  2/182 (1.10%)  1/191 (0.52%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Costochondritis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Flank pain * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Intervertebral disc protrusion * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Myositis * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Osteoporotic fracture * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Osteonecrosis * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Anal cancer * 1  2/182 (1.10%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Bile duct cancer * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Bronchial carcinoma * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hodgkin’s disease * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  2/272 (0.74%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Kaposi’s sarcoma * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lymphoma * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metastases to bone * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metastases to liver * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metastases to peritoneum * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metastatic salivary gland cancer * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metastatic squamous cell carcinoma * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Paraganglion neoplasm * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Prostate cancer * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Squamous cell carcinoma * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Squamous cell carcinoma of skin * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Tongue neoplasm malignant stage unspecified * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Nervous system disorders               
Cerebral haemorrhage * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Convulsion * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Demyelination * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Encephalitis * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Epilepsy * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
IIIrd nerve disorder * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lumbar radiculopathy * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Polyneuropathy * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Syncope * 1  0/182 (0.00%)  2/191 (1.05%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Transient ischaemic attack * 1  1/182 (0.55%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Pregnancy * 1  1/182 (0.55%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Psychiatric disorders               
Abnormal behaviour * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Depression * 1  2/182 (1.10%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Schizophrenia * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Suicidal ideation * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Renal and urinary disorders               
Proteinuria * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Renal colic * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Renal failure * 1  0/182 (0.00%)  2/191 (1.05%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Renal failure acute * 1  1/182 (0.55%)  1/191 (0.52%)  2/91 (2.20%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Acute respiratory failure * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Asthma * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  2/272 (0.74%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/182 (0.00%)  1/191 (0.52%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Dyspnoea * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Lung disorder * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pulmonary embolism * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pulmonary hypertension * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Respiratory arrest * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Skin and subcutaneous tissue disorders               
Lipohypertrophy * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Purpura * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Urticaria * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Surgical and medical procedures               
Arterial bypass operation * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Osteotomy * 1  0/182 (0.00%)  0/191 (0.00%)  0/91 (0.00%)  1/272 (0.37%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Vascular disorders               
Aortic arteriosclerosis * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Arterial occlusive disease * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Haematoma * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Hypertension * 1  1/182 (0.55%)  0/191 (0.00%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Iliac artery stenosis * 1  0/182 (0.00%)  0/191 (0.00%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Orthostatic hypotension * 1  0/182 (0.00%)  1/191 (0.52%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maraviroc QD Maraviroc BID Placebo Maraviroc BID, Open Label In Study-off Drug, Open Label Maraviroc BID, Observation Phase In Study-off Drug, Observation Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   138/182 (75.82%)   147/191 (76.96%)   64/91 (70.33%)   15/272 (5.51%)   0/50 (0.00%)   0/205 (0.00%)   0/65 (0.00%) 
Gastrointestinal disorders               
Abdominal pain * 1  13/182 (7.14%)  10/191 (5.24%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Abdominal pain upper * 1  15/182 (8.24%)  5/191 (2.62%)  4/91 (4.40%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Constipation * 1  10/182 (5.49%)  12/191 (6.28%)  6/91 (6.59%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Diarrhoea * 1  49/182 (26.92%)  39/191 (20.42%)  19/91 (20.88%)  15/272 (5.51%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Flatulence * 1  9/182 (4.95%)  4/191 (2.09%)  7/91 (7.69%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Nausea * 1  39/182 (21.43%)  33/191 (17.28%)  17/91 (18.68%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Vomiting * 1  24/182 (13.19%)  20/191 (10.47%)  9/91 (9.89%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
General disorders               
Asthenia * 1  11/182 (6.04%)  8/191 (4.19%)  3/91 (3.30%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Fatigue * 1  25/182 (13.74%)  22/191 (11.52%)  13/91 (14.29%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Injection site reaction * 1  12/182 (6.59%)  13/191 (6.81%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Pyrexia * 1  14/182 (7.69%)  26/191 (13.61%)  8/91 (8.79%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Infections and infestations               
Bronchitis * 1  18/182 (9.89%)  18/191 (9.42%)  7/91 (7.69%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Influenza * 1  10/182 (5.49%)  8/191 (4.19%)  0/91 (0.00%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Nasopharyngitis * 1  28/182 (15.38%)  27/191 (14.14%)  4/91 (4.40%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Oral candidiasis * 1  15/182 (8.24%)  8/191 (4.19%)  7/91 (7.69%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Upper respiratory tract infection * 1  20/182 (10.99%)  26/191 (13.61%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Investigations               
Weight decreased * 1  7/182 (3.85%)  8/191 (4.19%)  6/91 (6.59%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  14/182 (7.69%)  15/191 (7.85%)  9/91 (9.89%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  10/182 (5.49%)  14/191 (7.33%)  3/91 (3.30%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Back pain * 1  13/182 (7.14%)  10/191 (5.24%)  3/91 (3.30%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Muscle spasms * 1  10/182 (5.49%)  7/191 (3.66%)  4/91 (4.40%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Myalgia * 1  17/182 (9.34%)  11/191 (5.76%)  1/91 (1.10%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Nervous system disorders               
Dizziness * 1  17/182 (9.34%)  15/191 (7.85%)  8/91 (8.79%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Headache * 1  36/182 (19.78%)  30/191 (15.71%)  16/91 (17.58%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Neuropathy peripheral * 1  6/182 (3.30%)  11/191 (5.76%)  3/91 (3.30%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Psychiatric disorders               
Depression * 1  10/182 (5.49%)  14/191 (7.33%)  4/91 (4.40%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Insomnia * 1  10/182 (5.49%)  16/191 (8.38%)  4/91 (4.40%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1  17/182 (9.34%)  28/191 (14.66%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Skin and subcutaneous tissue disorders               
Pruritus * 1  5/182 (2.75%)  6/191 (3.14%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
Rash * 1  12/182 (6.59%)  17/191 (8.90%)  5/91 (5.49%)  0/272 (0.00%)  0/50 (0.00%)  0/205 (0.00%)  0/65 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00098722     History of Changes
Other Study ID Numbers: A4001028
First Submitted: December 7, 2004
First Posted: December 8, 2004
Results First Submitted: April 16, 2012
Results First Posted: May 16, 2012
Last Update Posted: May 16, 2012