Trial Outcomes & Findings for Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen (NCT NCT01400412)

NCT ID: NCT01400412

Last Updated: 2024-10-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 262 participants
• Primary outcome timeframe: Week 0, week 48
• Results posted on: 2024-10-15

Participant Flow

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

Participant milestones

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) 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 Study STARTED	130	132
Overall Study COMPLETED	120	115
Overall Study NOT COMPLETED	10	17

Reasons for withdrawal

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) 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 Study Lost to Follow-up	4	7
Overall Study Withdrawal by Subject	3	4
Overall Study Unable to complete	3	3
Overall Study Never started study treatment	0	3

Baseline Characteristics

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Baseline characteristics by cohort

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 Participants 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 n=259 Participants Total of all reporting groups
Age, Continuous	33 years n=5 Participants	33 years n=7 Participants	33 years n=5 Participants
Age, Customized 18-29 Years	49 participants n=5 Participants	48 participants n=7 Participants	97 participants n=5 Participants
Age, Customized 30-39 Years	40 participants n=5 Participants	41 participants n=7 Participants	81 participants n=5 Participants
Age, Customized 40-49 Years	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants
Age, Customized >=50 Years	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	120 Participants n=7 Participants	235 Participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic	57 participants n=5 Participants	59 participants n=7 Participants	116 participants n=5 Participants
Race/Ethnicity, Customized Black non-Hispanic	45 participants n=5 Participants	33 participants n=7 Participants	78 participants n=5 Participants
Race/Ethnicity, Customized Hispanic (regardless of race)	24 participants n=5 Participants	34 participants n=7 Participants	58 participants n=5 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized American Indian, Alaskan Native	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized More than one race	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants	127 participants n=7 Participants	254 participants n=5 Participants
Region of Enrollment Puerto Rico	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
CD4 count	389 cells/mm^3 n=5 Participants	392 cells/mm^3 n=7 Participants	390 cells/mm^3 n=5 Participants
HIV-1 RNA	4.59 log10 copies/mL n=5 Participants	4.47 log10 copies/mL n=7 Participants	4.50 log10 copies/mL n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 48

Population: 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.

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.

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=109 Participants 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.
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)	-1.51 percentage change Interval -2.93 to -0.11	-2.40 percentage change Interval -4.3 to -1.32

SECONDARY outcome

Timeframe: Week 0, week 48

Population: 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.

The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=114 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percent Change in Lumbar Spine Bone Mineral Density (BMD)	-0.88 percentage change Interval -2.93 to 1.3	-2.35 percentage change Interval -4.25 to -0.45

SECONDARY outcome

Timeframe: Week 0, week 24

Population: Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.

Change in CD4 count from baseline (week 0) to week 24

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=109 Participants 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.
Change in CD4 Count From Baseline to Week 24	165 cells/mm^3 Interval 75.0 to 245.0	127 cells/mm^3 Interval 35.0 to 225.0

SECONDARY outcome

Timeframe: Week 0, week 48

Population: Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.

Change in CD4 count from baseline (week 0) to week 48

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=117 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=111 Participants 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.
Change in CD4 Count From Baseline to Week 48	234 cells/mm^3 Interval 131.0 to 327.0	188 cells/mm^3 Interval 94.0 to 304.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

CD8+ T-cell change from baseline to week 48

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=117 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=111 Participants 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.
CD8+ T-cell Change From Baseline to Week 48	-6 cell/mm^3 Interval -252.0 to 175.0	-109 cell/mm^3 Interval -340.0 to 59.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48	-52.1 percentage change Interval -60.8 to -34.4	-48.6 percentage change Interval -65.3 to -31.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48	-59.5 percentage change Interval -70.5 to -43.5	-60.9 percentage change Interval -71.3 to -49.4

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48	-9.1 percentage change Interval -24.2 to 9.1	-11.2 percentage change Interval -29.3 to 16.2

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48	-3.5 percentage change Interval -16.9 to 6.5	-4.6 percentage change Interval -18.4 to 6.6

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48	11.9 percentage change Interval -6.0 to 37.0	14.0 percentage change Interval -2.6 to 38.4

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=108 Participants 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.
Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48	-20.7 percentage change Interval -54.9 to 45.8	-17.0 percentage change Interval -52.1 to 35.4

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

Change in levels of Interleukin 6 (IL-6) from baseline to week 48

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=116 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=107 Participants 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.
Change in Levels of IL-6 From Baseline to Week 48	-0.21 pg/ml Interval -0.91 to 0.25	-0.12 pg/ml Interval -0.83 to 0.42

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=116 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=107 Participants 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.
Change in Level of IP-10 From Baseline to Week 48	-198 pg/ml Interval -366.0 to -91.0	-170 pg/ml Interval -310.0 to -97.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

Change in levels of soluble CD163 from baseline to week 48

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=116 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=107 Participants 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.
Change in Levels of sCD163 From Baseline to Week 48	-250 ng/ml Interval -469.0 to -129.0	-258 ng/ml Interval -458.0 to -136.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

Change in levels of soluble CD14 from baseline

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=116 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=107 Participants 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.
Change in Levels of sCD14 From Baseline	-103 ng/ml Interval -268.0 to 63.0	-10 ng/ml Interval -212.0 to 159.0

SECONDARY outcome

Timeframe: At weeks 0 and 48

Population: 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.

Change in levels of D-dimer from baseline

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=115 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=106 Participants 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.
Change in Levels of D-dimer From Baseline	-82 ng/ml Interval -210.0 to -1.0	-61 ng/ml Interval -211.0 to -7.0

SECONDARY outcome

Timeframe: From study treatment initiation to week 48

Population: All participants who started study treatment

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.

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 Participants 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.
Cumulative Probability of Virologic Failure by Week 48	6 cumulative probability per 100 persons Interval 3.0 to 12.0	5 cumulative probability per 100 persons Interval 2.0 to 11.0

SECONDARY outcome

Timeframe: From study treatment initiation to week 48

Population: All participants who started study treatment

Number of participants who experienced bone fractures during the study

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 Participants 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.
Number of Participants Who Experienced Bone Fractures	2 participants	2 participants

SECONDARY outcome

Timeframe: From study treatment initiation to week 48

Population: All participants who started study treatment

Number of participants who died during the study

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 Participants 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.
Number of Participants Who Died During the Study	0 participants	0 participants

SECONDARY outcome

Timeframe: From study treatment initiation to week 48

Population: All participants who initiated study treatment

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)

Outcome measures

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 Participants 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 Participants 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.
Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events	16 participants	22 participants

Adverse Events

MVC Arm (DRV/r + MVC + FTC + TDF Placebo)

Serious events: 10 serious events

Other events: 101 other events

Deaths: 0 deaths

TDF Arm (DRV/r + TDF + FTC + MVC Placebo)

Serious events: 4 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 participants at risk 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 participants at risk 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.
Gastrointestinal disorders Intestinal ischaemia	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Infections and infestations Abscess limb	0.00% 0/130 • week 0 to week 48 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.	0.78% 1/129 • week 0 to week 48 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.
Infections and infestations Perineal abscess	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Infections and infestations Pneumonia	1.5% 2/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Injury, poisoning and procedural complications Road traffic accident	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Investigations Weight decreased	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/130 • week 0 to week 48 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.	0.78% 1/129 • week 0 to week 48 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.
Nervous system disorders Headache	0.00% 0/130 • week 0 to week 48 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.	0.78% 1/129 • week 0 to week 48 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.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Psychiatric disorders Major depression	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Psychiatric disorders Suicide attempt	0.00% 0/130 • week 0 to week 48 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.	0.78% 1/129 • week 0 to week 48 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.
Skin and subcutaneous tissue disorders Rash	0.77% 1/130 • week 0 to week 48 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.	0.00% 0/129 • week 0 to week 48 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.

Other adverse events

Measure	MVC Arm (DRV/r + MVC + FTC + TDF Placebo) n=130 participants at risk 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.	TDF Arm (DRV/r + TDF + FTC + MVC Placebo) n=129 participants at risk 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.
Investigations Alanine aminotransferase increased	9.2% 12/130 • week 0 to week 48 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.	11.6% 15/129 • week 0 to week 48 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.
Investigations Aspartate aminotransferase increased	9.2% 12/130 • week 0 to week 48 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.	7.8% 10/129 • week 0 to week 48 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.
Investigations Blood cholesterol increased	46.2% 60/130 • week 0 to week 48 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.	30.2% 39/129 • week 0 to week 48 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.
Investigations Blood creatinine increased	2.3% 3/130 • week 0 to week 48 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.	6.2% 8/129 • week 0 to week 48 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.
Investigations Blood glucose decreased	5.4% 7/130 • week 0 to week 48 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.	3.9% 5/129 • week 0 to week 48 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.
Investigations Blood glucose increased	9.2% 12/130 • week 0 to week 48 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.	7.0% 9/129 • week 0 to week 48 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.
Investigations Blood phosphorus decreased	20.8% 27/130 • week 0 to week 48 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.	18.6% 24/129 • week 0 to week 48 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.
Investigations Blood sodium decreased	7.7% 10/130 • week 0 to week 48 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.	8.5% 11/129 • week 0 to week 48 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.
Investigations Low density lipoprotein increased	35.4% 46/130 • week 0 to week 48 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.	20.2% 26/129 • week 0 to week 48 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.
Investigations Neutrophil count decreased	10.0% 13/130 • week 0 to week 48 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.	7.8% 10/129 • week 0 to week 48 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER