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Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

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ClinicalTrials.gov Identifier: NCT01400412
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : July 15, 2015
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: Darunavir
Drug: Ritonavir
Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine
Drug: Placebo for Tenofovir disoproxil fumarate
Drug: Placebo for Maraviroc
Drug: Maraviroc
Enrollment 262

Recruitment Details A5303 opened under version 1.0 on 12/4/11, and the first participant was enrolled on 1/17/12. Accrual to the study closed on 6/12/13, with a total of 262 participants enrolled at 38 sites
Pre-assignment Details  
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Period Title: Overall Study
Started 130 132
Completed 120 115
Not Completed 10 17
Reason Not Completed
Lost to Follow-up             4             7
Withdrawal by Subject             3             4
Unable to complete             3             3
Never started study treatment             0             3
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo) Total
Hide Arm/Group Description

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Total of all reporting groups
Overall Number of Baseline Participants 130 129 259
Hide Baseline Analysis Population Description
Participants who started study treatment
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 130 participants 129 participants 259 participants
33
(26 to 42)
33
(26 to 42)
33
(26 to 42)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 259 participants
18-29 Years 49 48 97
30-39 Years 40 41 81
40-49 Years 26 24 50
>=50 Years 15 16 31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 259 participants
Female
15
  11.5%
9
   7.0%
24
   9.3%
Male
115
  88.5%
120
  93.0%
235
  90.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 259 participants
White non-Hispanic 57 59 116
Black non-Hispanic 45 33 78
Hispanic (regardless of race) 24 34 58
Asian, Pacific Islander 2 1 3
American Indian, Alaskan Native 0 1 1
More than one race 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 259 participants
United States 127 127 254
Puerto Rico 3 2 5
CD4 count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 130 participants 129 participants 259 participants
389
(295 to 496)
392
(290 to 518)
390
(294 to 517)
HIV-1 RNA  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 130 participants 129 participants 259 participants
4.59
(3.91 to 5.07)
4.47
(4.02 to 4.91)
4.50
(3.97 to 5.00)
1.Primary Outcome
Title Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)
Hide Description The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.
Time Frame Week 0, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 109
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-1.51
(-2.93 to -0.11)
-2.40
(-4.30 to -1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC Arm (DRV/r + MVC + FTC + TDF Placebo), TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Comments The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance
Method Wilcoxon (Mann-Whitney)
Comments Stratified Wilcoxon rank sum test stratified by age (<30 and >=30 years)
2.Secondary Outcome
Title Percent Change in Lumbar Spine Bone Mineral Density (BMD)
Hide Description The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.
Time Frame Week 0, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 114 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-0.88
(-2.93 to 1.30)
-2.35
(-4.25 to -0.45)
3.Secondary Outcome
Title Change in CD4 Count From Baseline to Week 24
Hide Description Change in CD4 count from baseline (week 0) to week 24
Time Frame Week 0, week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 109
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
165
(75 to 245)
127
(35 to 225)
4.Secondary Outcome
Title Change in CD4 Count From Baseline to Week 48
Hide Description Change in CD4 count from baseline (week 0) to week 48
Time Frame Week 0, week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 117 111
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
234
(131 to 327)
188
(94 to 304)
5.Secondary Outcome
Title CD8+ T-cell Change From Baseline to Week 48
Hide Description [Not Specified]
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 117 111
Median (Inter-Quartile Range)
Unit of Measure: cell/mm^3
-6
(-252 to 175)
-109
(-340 to 59)
6.Secondary Outcome
Title Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48
Hide Description percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-52.1
(-60.8 to -34.4)
-48.6
(-65.3 to -31.0)
7.Secondary Outcome
Title Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48
Hide Description percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm: DRV/r + MVC + FTC + TDF Placebo TDF Arm: DRV/r + TDF + FTC + MVC Placebo
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-59.5
(-70.5 to -43.5)
-60.9
(-71.3 to -49.4)
8.Secondary Outcome
Title Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48
Hide Description percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-9.1
(-24.2 to 9.1)
-11.2
(-29.3 to 16.2)
9.Secondary Outcome
Title Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48
Hide Description percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-3.5
(-16.9 to 6.5)
-4.6
(-18.4 to 6.6)
10.Secondary Outcome
Title Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48
Hide Description percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
11.9
(-6.0 to 37.0)
14.0
(-2.6 to 38.4)
11.Secondary Outcome
Title Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48
Hide Description percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 108
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-20.7
(-54.9 to 45.8)
-17.0
(-52.1 to 35.4)
12.Secondary Outcome
Title Change in Levels of IL-6 From Baseline to Week 48
Hide Description Change in levels of Interleukin 6 (IL-6) from baseline to week 48
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 116 107
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.21
(-0.91 to 0.25)
-0.12
(-0.83 to 0.42)
13.Secondary Outcome
Title Change in Level of IP-10 From Baseline to Week 48
Hide Description Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 116 107
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-198
(-366 to -91)
-170
(-310 to -97)
14.Secondary Outcome
Title Change in Levels of sCD163 From Baseline to Week 48
Hide Description Change in levels of soluble CD163 from baseline to week 48
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 116 107
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-250
(-469 to -129)
-258
(-458 to -136)
15.Secondary Outcome
Title Change in Levels of sCD14 From Baseline
Hide Description Change in levels of soluble CD14 from baseline
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 116 107
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-103
(-268 to 63)
-10
(-212 to 159)
16.Secondary Outcome
Title Change in Levels of D-dimer From Baseline
Hide Description [Not Specified]
Time Frame At weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 115 106
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-82
(-210 to -1)
-61
(-211 to -7)
17.Secondary Outcome
Title Cumulative Probability of Virologic Failure by Week 48
Hide Description

Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.

Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group.

Time Frame From study treatment initiation to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 130 129
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative probability per 100 persons
6
(3 to 12)
5
(2 to 11)
18.Secondary Outcome
Title Number of Participants Who Experienced Bone Fractures
Hide Description Number of participants who experienced bone fractures during the study
Time Frame From study treatment initiation to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 130 129
Measure Type: Number
Unit of Measure: participants
2 2
19.Secondary Outcome
Title Number of Participants Who Died During the Study
Hide Description [Not Specified]
Time Frame From study treatment initiation to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 130 129
Measure Type: Number
Unit of Measure: participants
0 0
20.Secondary Outcome
Title Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events
Hide Description

Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.

See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)

Time Frame From study treatment initiation to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who initiated study treatment
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description:

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

Overall Number of Participants Analyzed 130 129
Measure Type: Number
Unit of Measure: participants
16 22
Time Frame week 0 to week 48
Adverse Event Reporting Description Adverse events from participants' first study treatment date to off study date. See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009). All targeted events (see protocol 6.3.4), grade >=3 signs/symptoms or laboratory toxicities, or any adverse events that led to a change in study treatment were required to be recorded.
 
Arm/Group Title MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Hide Arm/Group Description

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.

Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet.

All-Cause Mortality
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/130 (7.69%)   4/129 (3.10%) 
Gastrointestinal disorders     
Intestinal ischaemia  1  1/130 (0.77%)  0/129 (0.00%) 
Infections and infestations     
Abscess limb  1  0/130 (0.00%)  1/129 (0.78%) 
Perineal abscess  1  1/130 (0.77%)  0/129 (0.00%) 
Pneumonia  1  2/130 (1.54%)  0/129 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/130 (0.77%)  0/129 (0.00%) 
Investigations     
Weight decreased  1  1/130 (0.77%)  0/129 (0.00%) 
Metabolism and nutrition disorders     
Abnormal loss of weight  1  0/130 (0.00%)  1/129 (0.78%) 
Nervous system disorders     
Headache  1  0/130 (0.00%)  1/129 (0.78%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/130 (0.77%)  0/129 (0.00%) 
Psychiatric disorders     
Major depression  1  1/130 (0.77%)  0/129 (0.00%) 
Suicide attempt  1  0/130 (0.00%)  1/129 (0.78%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/130 (0.77%)  0/129 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/130 (0.77%)  0/129 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) TDF Arm (DRV/r + TDF + FTC + MVC Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   101/130 (77.69%)   78/129 (60.47%) 
Investigations     
Alanine aminotransferase increased  1  12/130 (9.23%)  15/129 (11.63%) 
Aspartate aminotransferase increased  1  12/130 (9.23%)  10/129 (7.75%) 
Blood cholesterol increased  1  60/130 (46.15%)  39/129 (30.23%) 
Blood creatinine increased  1  3/130 (2.31%)  8/129 (6.20%) 
Blood glucose decreased  1  7/130 (5.38%)  5/129 (3.88%) 
Blood glucose increased  1  12/130 (9.23%)  9/129 (6.98%) 
Blood phosphorus decreased  1  27/130 (20.77%)  24/129 (18.60%) 
Blood sodium decreased  1  10/130 (7.69%)  11/129 (8.53%) 
Low density lipoprotein increased  1  46/130 (35.38%)  26/129 (20.16%) 
Neutrophil count decreased  1  13/130 (10.00%)  10/129 (7.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems
Phone: 301-628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01400412     History of Changes
Other Study ID Numbers: ACTG A5303
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2011
First Posted: July 22, 2011
Results First Submitted: June 17, 2015
Results First Posted: July 15, 2015
Last Update Posted: February 22, 2018