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Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1 (MODERN)

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ClinicalTrials.gov Identifier: NCT01345630
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 2, 2011
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV-1
Interventions Drug: Maraviroc
Drug: Emtricitabine/tenofovir
Drug: darunavir/ritonavir 800/100 mg
Drug: placebo for emtricitabine/tenofovir
Drug: placebo for maraviroc
Enrollment 813

Recruitment Details Overall, 1423 participants were screened and 813 participants randomized in the study. A total of 797 participants were treated (396 were treated in the maraviroc + darunavir/ritonavir [MVC+DRV/r] group and 401 in the emtricitabine/tenofovir + darunavir/ritonavir [FTC/TDF+DRV/r] group). The study was conducted in 138 sites in 18 countries.
Pre-assignment Details Participants were randomized to undergo either genotype testing or enhanced Trofile assay (ESTA) in a 1:1 ratio. Among participants who were identified as being infected with R5 tropic HIV-1 by either testing methods, 813 were randomized in a 1:1 ratio to receive 96-week treatment either in the MVC+DRV/r arm or in the FTC/TDF+DRV/r arm.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Period Title: Overall Study
Started 396 401
Completed 35 42
Not Completed 361 359
Reason Not Completed
Adverse Event             22             23
Lost to Follow-up             17             16
Protocol Violation             4             1
Medication error without associated AE             0             1
Study terminated by sponsor             254             285
Other reasons             6             8
Withdrawn due to pregnancy             1             2
No longer willing to participate             9             12
Insufficient clinical response             48             11
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r Total
Hide Arm/Group Description Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Total of all reporting groups
Overall Number of Baseline Participants 396 401 797
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants 401 participants 797 participants
37.9  (10.9) 36.2  (10.9) 37.1  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 401 participants 797 participants
Female
36
   9.1%
34
   8.5%
70
   8.8%
Male
360
  90.9%
367
  91.5%
727
  91.2%
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
Hide Description The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “Outcome Measure Description” above.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: Percentage of participants
77.3 86.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (>=100,000 copies/mL or <100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.54
Confidence Interval (2-Sided) 95%
-14.83 to -4.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Frequency of Adverse Events (AE).
Hide Description Number of participants with treatment-emergent non serious AEs
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: participants
360 365
3.Secondary Outcome
Title Number of Participants With Grade 3 or 4 AEs
Hide Description Number of participants with grade 3 or 4 AEs are presented here.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: participants
65 71
4.Secondary Outcome
Title Number of Participants Who Discontinued Due to AEs
Hide Description Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: participants
22 23
5.Secondary Outcome
Title Number of Treatment-related AEs
Hide Description Number of treatment-related AEs are presented here.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: events
316 361
6.Secondary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Events
Hide Description Total number of participants with treatment-emergent serious adverse events are reported
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: participants
41 40
7.Secondary Outcome
Title Number of Participants With Abnormal Laboratory Values
Hide Description Number of participants with laboratory abnormalities are reported
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 400
Measure Type: Number
Unit of Measure: participants
Normal Baseline 210 205
Abnormal Baseline 111 101
8.Secondary Outcome
Title Severity of Abnormal Laboratory Values
Hide Description Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: participants
Alanine Aminotransferase (ALT) (n=396, 400) 9 6
Alkaline Phosphatase (n=396, 400) 1 0
Amylase (n=396, 400) 5 13
Aspartate Aminotransferase (AST) (n=396, 400) 11 7
Blood Urea Nitrogen (BUN) (n=396, 400) 3 5
Calcium (n=396, 400) 7 10
Creatine Kinase (n=396, 400) 18 22
Hemoglobin (n=396, 400) 4 2
LDL Cholesterol (n=396, 400) 50 24
Lipase (n=116, 122) 3 10
Lymphocytes (Abs) (n=396, 400) 2 2
Phosphate (n=396, 400) 5 12
Platelets (n=396, 400) 5 1
Potassium (n=396, 400) 3 2
Sodium (n=396, 400) 2 0
Total Bilirubin (n=396, 400) 3 1
Total Neutrophils (Abs) (n=396, 400) 6 2
Triglycerides (n=396, 400) 4 6
Uric Acid (n=396, 400) 0 2
White Blood Cell Count (n=396, 400) 1 0
Creatinine (n=396, 400) 0 1
9.Secondary Outcome
Title The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
Hide Description The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA’s Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: proportion of participants
0.8047 0.8797
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments The difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at Week 48 between the [MVC+DRV/r] and the [FTC/TDF+DRV/r] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.0750
Confidence Interval (2-Sided) 95%
-0.1343 to -0.0157
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0303
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
Hide Description Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. No imputation for missing values was performed for this endpoint. 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Measure Type: Number
Unit of Measure: Number of participants
Confirmed PDTF 40 13
Evaluable PDTF 17 3
11.Secondary Outcome
Title Tropism Change Between Screening or Baseline and PDTF
Hide Description For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).
Arm/Group Title MVC+DRV/r - Baseline MVC+DRV/r - Failure FTC/TDF+DRV/r - Baseline FTC/TDF+DRV/r - Failure
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
Overall Number of Participants Analyzed 17 17 3 3
Measure Type: Number
Unit of Measure: participants
R5 (Randomized Assay) 14 13 2 1
NON R5 (Randomized Assay) 1 1 0 0
NR (Randomized Assay) 2 3 1 2
R5 (Alternate Assay) 10 10 3 2
NON R5 (Alternate Assay) 2 3 0 1
NR (Alternate Assay) 5 4 0 0
12.Secondary Outcome
Title Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
Hide Description For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 17 3
Measure Type: Number
Unit of Measure: participants
Not eligible for analysis (failed tropism test) 4 1
Not eligible for analysis (non-R5 tropism) 1 1
Eligible for analysis (R5 virus using ESTA) 12 1
Results reported 12 1
Maximal percent inhibition <95% 0 0
IC50 FC ≥3.0 0 0
13.Secondary Outcome
Title Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
Hide Description For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI’s were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. The assessment was performed using the overall (ie. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15 for the MVC+DRV/r arm and 3 for the FTC/TDF+DRV/r arm.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
NRTI - All (Baseline, n=15, 3) 0 0
NNRTI Delavirdine (Baseline, n=15, 3) 1 0
NNRTI Nevirapine (Baseline, n=15, 3) 1 0
NNRTI Efavirenz (Baseline, n=15, 3) 1 0
PRI - All (Baseline, n=15, 3) 0 0
NRTI - All (PDTF, n=15, 3) 0 0
NNRTI Delavirdine (PDTF, n=15, 3) 1 0
NNRTI Nevirapine (PDTF, n=15, 3) 1 0
NNRTI Efavirenz (PDTF, n=15, 3) 1 0
PRI - All (PDTF, n=15, 3) 0 0
14.Secondary Outcome
Title Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
Hide Description The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Mean (Standard Deviation)
Unit of Measure: cell/mm^3
Baseline (n=396, 401) 382.0  (173.4) 379.5  (170.9)
Week 48 (n=394, 396) 576.9  (226.0) 574.6  (232.1)
Change from Baseline at Week 48 (n=394, 396) 194.9  (175.5) 194.2  (175.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9750
Comments Not specified.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-24.4 to 23.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
Hide Description The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Mean (Standard Deviation)
Unit of Measure: Percentage of lymphocytes
Baseline (n=396, 401) 24.2  (7.9) 24.5  (8.2)
Week 48 (n=394, 396) 31.3  (8.3) 33.7  (8.6)
Change from Baseline at Week 48 (n=394, 396) 7.0  (5.7) 9.2  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-3.1 to -1.5
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
Hide Description The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Mean (Standard Deviation)
Unit of Measure: cell/mm^3
Baseline (n=396, 401) 954.4  (502.1) 914.5  (473.0)
Week 48 (n=394, 396) 900.0  (508.3) 751.1  (386.7)
Change from Baseline at Week 48 (n=394, 396) -49.9  (410.7) -157.9  (444.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 127.7
Confidence Interval (2-Sided) 95%
76.5 to 178.8
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
Hide Description The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Mean (Standard Deviation)
Unit of Measure: Percentage of lymphocytes
Baseline (n=396, 401) 57.0  (10.7) 55.8  (10.5)
Week 48 (n=394, 396) 46.0  (10.4) 43.0  (10.2)
Change from Baseline at Week 48 (n=394, 396) -10.9  (7.2) -12.6  (8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.1 to 3.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
Hide Description The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 396 401
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline (n=396, 401) 0.47  (0.24) 0.48  (0.25)
Week 48 (n=394, 396) 0.75  (0.34) 0.87  (0.45)
Change from Baseline at Week 48 (n=394, 396) 0.28  (0.22) 0.39  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.15 to -0.07
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
Hide Description A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 52 56
Least Squares Mean (Standard Error)
Unit of Measure: gram
-181.6  (569.8) -257.5  (556.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8379
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 75.861
Confidence Interval (2-Sided) 95%
-658.181 to 809.903
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
Hide Description A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 52 56
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.017  (0.048) -0.014  (0.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3376
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.031
Confidence Interval (2-Sided) 95%
-0.033 to 0.094
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
Hide Description Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 47 57
Least Squares Mean (Standard Error)
Unit of Measure: g/cm^2
-0.014  (0.005) -0.028  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
0.004 to 0.023
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
Hide Description Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 47 57
Least Squares Mean (Standard Error)
Unit of Measure: g/cm^2
-0.021  (0.007) -0.029  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2273
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.008
Confidence Interval (2-Sided) 95%
-0.005 to 0.022
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
Hide Description Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 54 60
Least Squares Mean (Standard Error)
Unit of Measure: g/cm^2
-0.020  (0.006) -0.025  (0.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4188
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.007 to 0.018
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
Hide Description Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 52 61
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.61  (8.02) 6.77  (8.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1722
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.12
Confidence Interval (2-Sided) 95%
-5.17 to 0.94
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
Hide Description Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description:
Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Overall Number of Participants Analyzed 53 62
Mean (Standard Deviation)
Unit of Measure: pg/mL
121.13  (243.03) 223.52  (293.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC+DRV/r, FTC/TDF+DRV/r
Comments Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -126.78
Confidence Interval (2-Sided) 95%
-218.34 to -35.23
Estimation Comments [Not Specified]
Time Frame From the day the first dose of the study drug was administered to 28 days after the last dose of the study drug was administered.
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title MVC+DRV/r FTC/TDF+DRV/r
Hide Arm/Group Description Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
All-Cause Mortality
MVC+DRV/r FTC/TDF+DRV/r
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MVC+DRV/r FTC/TDF+DRV/r
Affected / at Risk (%) Affected / at Risk (%)
Total   41/396 (10.35%)   40/401 (9.98%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  0/396 (0.00%)  1/401 (0.25%) 
Cardiac disorders     
Myocardial infarction  1  0/396 (0.00%)  1/401 (0.25%) 
Pericarditis  1  1/396 (0.25%)  0/401 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/396 (0.00%)  1/401 (0.25%) 
Anal fistula  1  0/396 (0.00%)  1/401 (0.25%) 
Anal haemorrhage  1  0/396 (0.00%)  1/401 (0.25%) 
Colitis  1  2/396 (0.51%)  0/401 (0.00%) 
Diarrhoea  1  1/396 (0.25%)  0/401 (0.00%) 
Enterocolitis  1  1/396 (0.25%)  0/401 (0.00%) 
Hiatus hernia  1  1/396 (0.25%)  1/401 (0.25%) 
Proctitis  1  1/396 (0.25%)  0/401 (0.00%) 
Proctitis ulcerative  1  0/396 (0.00%)  1/401 (0.25%) 
Gastrointestinal necrosis  1  0/396 (0.00%)  1/401 (0.25%) 
General disorders     
Chest pain  1  2/396 (0.51%)  1/401 (0.25%) 
Hernia  1  1/396 (0.25%)  0/401 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/396 (0.00%)  1/401 (0.25%) 
Cholecystitis acute  1  0/396 (0.00%)  1/401 (0.25%) 
Cholelithiasis  1  1/396 (0.25%)  0/401 (0.00%) 
THROMBUS, AORTIC HEPATIC ARTERY  1 [1]  0/396 (0.00%)  1/401 (0.25%) 
Immune system disorders     
Anaphylactic reaction  1  1/396 (0.25%)  0/401 (0.00%) 
Infections and infestations     
Acute hepatitis C  1  0/396 (0.00%)  2/401 (0.50%) 
Anal abscess  1  1/396 (0.25%)  1/401 (0.25%) 
Cerebral toxoplasmosis  1  0/396 (0.00%)  1/401 (0.25%) 
Chronic sinusitis  1  0/396 (0.00%)  1/401 (0.25%) 
Eye infection syphilitic  1  0/396 (0.00%)  1/401 (0.25%) 
Gastroenteritis  1  0/396 (0.00%)  1/401 (0.25%) 
Hepatitis A  1  0/396 (0.00%)  1/401 (0.25%) 
Lymph node abscess  1  0/396 (0.00%)  1/401 (0.25%) 
Neurosyphilis  1  1/396 (0.25%)  0/401 (0.00%) 
Pharyngotonsillitis  1  0/396 (0.00%)  1/401 (0.25%) 
Pneumonia bacterial  1  1/396 (0.25%)  1/401 (0.25%) 
Pneumonia viral  1  0/396 (0.00%)  1/401 (0.25%) 
Pyelonephritis  1  1/396 (0.25%)  1/401 (0.25%) 
Viral infection  1  1/396 (0.25%)  0/401 (0.00%) 
Amoebic dysentery  1  0/396 (0.00%)  1/401 (0.25%) 
Epididymitis  1  1/396 (0.25%)  0/401 (0.00%) 
Pneumonia  1  1/396 (0.25%)  0/401 (0.00%) 
Shigella infection  1  1/396 (0.25%)  0/401 (0.00%) 
Herpes zoster infection neurological  1  1/396 (0.25%)  0/401 (0.00%) 
Injury, poisoning and procedural complications     
Patella fracture  1  1/396 (0.25%)  0/401 (0.00%) 
Toxicity to various agents  1  1/396 (0.25%)  2/401 (0.50%) 
Concussion  1  1/396 (0.25%)  0/401 (0.00%) 
Radius fracture  1  0/396 (0.00%)  1/401 (0.25%) 
Investigations     
Amylase increased  1  0/396 (0.00%)  1/401 (0.25%) 
Hepatic enzyme increased  1  1/396 (0.25%)  0/401 (0.00%) 
Metabolism and nutrition disorders     
Abnormal loss of weight  1  1/396 (0.25%)  1/401 (0.25%) 
Dehydration  1  0/396 (0.00%)  1/401 (0.25%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/396 (0.25%)  0/401 (0.00%) 
Rhabdomyolysis  1  0/396 (0.00%)  2/401 (0.50%) 
Osteoarthritis  1  0/396 (0.00%)  1/401 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hodgkin's disease  1  2/396 (0.51%)  0/401 (0.00%) 
Kaposi's sarcoma  1  1/396 (0.25%)  1/401 (0.25%) 
Lung adenocarcinoma  1  1/396 (0.25%)  0/401 (0.00%) 
Lymphoma  1  1/396 (0.25%)  0/401 (0.00%) 
Castleman’s disease  1  1/396 (0.25%)  0/401 (0.00%) 
Testis cancer  1  0/396 (0.00%)  1/401 (0.25%) 
Uterine leiomyoma  1  1/396 (0.25%)  0/401 (0.00%) 
Nervous system disorders     
Loss of consciousness  1  0/396 (0.00%)  1/401 (0.25%) 
Syncope  1  1/396 (0.25%)  0/401 (0.00%) 
Presyncope  1  0/396 (0.00%)  1/401 (0.25%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy  1  1/396 (0.25%)  0/401 (0.00%) 
Psychiatric disorders     
Anxiety disorder  1  0/396 (0.00%)  1/401 (0.25%) 
Bipolar I disorder  1  1/396 (0.25%)  0/401 (0.00%) 
Depression  1  2/396 (0.51%)  1/401 (0.25%) 
Drug abuse  1  0/396 (0.00%)  1/401 (0.25%) 
Drug dependence  1  1/396 (0.25%)  0/401 (0.00%) 
Mania  1  1/396 (0.25%)  0/401 (0.00%) 
Stress  1  0/396 (0.00%)  1/401 (0.25%) 
Suicidal ideation  1  1/396 (0.25%)  2/401 (0.50%) 
Suicide attempt  1  1/396 (0.25%)  2/401 (0.50%) 
Alcohol withdrawal syndrome  1  0/396 (0.00%)  1/401 (0.25%) 
Major depression  1  0/396 (0.00%)  2/401 (0.50%) 
Mental disorder  1  0/396 (0.00%)  1/401 (0.25%) 
Schizophrenia  1  0/396 (0.00%)  1/401 (0.25%) 
Renal and urinary disorders     
Haematuria  1  1/396 (0.25%)  0/401 (0.00%) 
Reproductive system and breast disorders     
Priapism  1  1/396 (0.25%)  0/401 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/396 (0.25%)  0/401 (0.00%) 
Pulmonary embolism  1  1/396 (0.25%)  0/401 (0.00%) 
Asthma  1  0/396 (0.00%)  1/401 (0.25%) 
Chronic obstructive pulmonary disease  1  1/396 (0.25%)  0/401 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/396 (0.25%)  0/401 (0.00%) 
Surgical and medical procedures     
Drug rehabilitation  1  0/396 (0.00%)  2/401 (0.50%) 
Papilloma excision  1  0/396 (0.00%)  1/401 (0.25%) 
Anal lesion excision  1  0/396 (0.00%)  1/401 (0.25%) 
Vascular disorders     
Deep vein thrombosis  1  1/396 (0.25%)  0/401 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v17.0
[1]
BEING QUERIED
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MVC+DRV/r FTC/TDF+DRV/r
Affected / at Risk (%) Affected / at Risk (%)
Total   257/396 (64.90%)   285/401 (71.07%) 
Gastrointestinal disorders     
Diarrhoea  1  88/396 (22.22%)  135/401 (33.67%) 
Nausea  1  34/396 (8.59%)  45/401 (11.22%) 
Abdominal distension  1  9/396 (2.27%)  22/401 (5.49%) 
General disorders     
Fatigue  1  27/396 (6.82%)  46/401 (11.47%) 
Infections and infestations     
Bronchitis  1  25/396 (6.31%)  24/401 (5.99%) 
Gastroenteritis  1  23/396 (5.81%)  16/401 (3.99%) 
Nasopharyngitis  1  48/396 (12.12%)  55/401 (13.72%) 
Upper respiratory tract infection  1  40/396 (10.10%)  45/401 (11.22%) 
Influenza  1  22/396 (5.56%)  20/401 (4.99%) 
Syphilis  1  15/396 (3.79%)  23/401 (5.74%) 
Investigations     
Blood cholesterol increased  1  22/396 (5.56%)  10/401 (2.49%) 
Low density lipoprotein increased  1  22/396 (5.56%)  11/401 (2.74%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  22/396 (5.56%)  23/401 (5.74%) 
Nervous system disorders     
Headache  1  27/396 (6.82%)  47/401 (11.72%) 
Psychiatric disorders     
Depression  1  26/396 (6.57%)  29/401 (7.23%) 
Insomnia  1  15/396 (3.79%)  25/401 (6.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  27/396 (6.82%)  30/401 (7.48%) 
Skin and subcutaneous tissue disorders     
Rash  1  37/396 (9.34%)  30/401 (7.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v17.0
The study was terminated following a preliminary review of the 48- week primary clinical efficacy data by the study’s external independent Data Monitoring Committee’s recommendation based on inferior efficacy of the investigational MVC+DRV/r arm.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01345630     History of Changes
Other Study ID Numbers: A4001095
2010-021785-30 ( EudraCT Number )
First Submitted: April 27, 2011
First Posted: May 2, 2011
Results First Submitted: August 14, 2014
Results First Posted: January 14, 2016
Last Update Posted: January 14, 2016