Trial Outcomes & Findings for Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND) (NCT NCT02519777)

NCT ID: NCT02519777

Last Updated: 2022-04-22

Results Overview

The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests: Domestic (US-based) and International Participants: * Grooved pegboard dominant * Grooved pegboard non-dominant * Hopkins Verbal Learning Test (HVLT-R) Learning trials * HVLT-R Delayed recall * HVLT-R Delayed recognition * Semantic verbal fluency Domestic only: * Stroop color naming * Stroop word reading * Stroop interference trial * Letter fluency * Trail Making A * Trail Making B * WAIS-III Symbol search * Digit Symbol International only: * Timed Gait * Finger Tapping Dominant * Finger Tapping Non-dominant * Color Trail 1 Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at Week 48 minus the total z-score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

191 participants

Primary outcome timeframe

Measured at Baseline and Week 48

Results posted on

2022-04-22

Participant Flow

Participants were enrolled at 30 Clinical Research Sites (CRSs) in the United States, Thailand, Brazil, and South Africa between April 2016 and November 2018.

Participant milestones

Participant milestones
Measure	Arm A: Placebo MVC and Placebo DTG In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Overall Study STARTED	63	67	61
Overall Study COMPLETED	57	59	57
Overall Study NOT COMPLETED	6	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Placebo MVC and Placebo DTG In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Overall Study Death	1	0	0
Overall Study Lost to Follow-up	0	4	2
Overall Study Withdrawal by Subject	3	1	0
Overall Study Severe Debilitation	1	1	1
Overall Study Not able to get to clinic	1	2	1

Baseline Characteristics

Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=61 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen	Total n=191 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 7 • n=5 Participants	52 years STANDARD_DEVIATION 9 • n=7 Participants	52 years STANDARD_DEVIATION 8 • n=5 Participants	52 years STANDARD_DEVIATION 8 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	135 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	42 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	50 Participants n=7 Participants	51 Participants n=5 Participants	149 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	30 Participants n=7 Participants	37 Participants n=5 Participants	97 Participants n=4 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	29 Participants n=7 Participants	16 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Normalized Neurocognitive Test Scores	-0.96 total neurocognitive z-score STANDARD_DEVIATION 0.79 • n=5 Participants	-0.97 total neurocognitive z-score STANDARD_DEVIATION 0.70 • n=7 Participants	-1.09 total neurocognitive z-score STANDARD_DEVIATION 0.70 • n=5 Participants	-1.00 total neurocognitive z-score STANDARD_DEVIATION 0.73 • n=4 Participants
CD4 Cell Count	681 cells/mm^3 STANDARD_DEVIATION 294 • n=5 Participants	703 cells/mm^3 STANDARD_DEVIATION 278 • n=7 Participants	726 cells/mm^3 STANDARD_DEVIATION 331 • n=5 Participants	703 cells/mm^3 STANDARD_DEVIATION 300 • n=4 Participants
CD8 Cell Count	789 cells/mm^3 STANDARD_DEVIATION 334 • n=5 Participants	809 cells/mm^3 STANDARD_DEVIATION 393 • n=7 Participants	816 cells/mm^3 STANDARD_DEVIATION 393 • n=5 Participants	805 cells/mm^3 STANDARD_DEVIATION 373 • n=4 Participants
HIV RNA <50 copies/mL	62 Participants n=5 Participants	64 Participants n=7 Participants	58 Participants n=5 Participants	184 Participants n=4 Participants
HIV RNA ≥50 copies/mL	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and Week 48

Population: All participants who started study treatment were included in the analysis. Analysis performed under intention to treat (ITT) principle, all eligible randomized participants were included in the analysis.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline	0.20 total neurocognitive z-score Interval 0.02 to 0.37	0.26 total neurocognitive z-score Interval 0.11 to 0.4	0.31 total neurocognitive z-score Interval 0.16 to 0.46

SECONDARY outcome

Timeframe: Measured from treatment initiation through Week 96

Population: All participants who were randomized were included in the analysis

Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=61 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Number of Participants With Treatment Related Adverse Events (AEs)	3 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 24, 72, and 96

The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests: Domestic and International Participants: * Grooved pegboard dominant * Grooved pegboard non-dominant * HVLT-R Learning trials * HVLT-R Delayed recall * HVLT-R Delayed recognition * Semantic verbal fluency Domestic only: * Stroop color naming * Stroop word reading * Stroop interference trial * Letter fluency * Trail Making A * Trail Making B * WAIS-III Symbol search * Digit Symbol International only: * Timed Gait * Finger Tapping Dominant * Finger Tapping Non-dominant * Color Trail 1 * Color Trail 2 Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at the given time point minus the total z-score at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline Change of Normalized Composite Neurocognitive Test Score (Week 24)	0.14 total neurocognitive z-score Interval -0.02 to 0.3	0.18 total neurocognitive z-score Interval 0.08 to 0.28	0.20 total neurocognitive z-score Interval 0.07 to 0.33
Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline Change of Normalized Composite Neurocognitive Test Score (Week 72)	0.29 total neurocognitive z-score Interval 0.12 to 0.45	0.32 total neurocognitive z-score Interval 0.19 to 0.46	0.37 total neurocognitive z-score Interval 0.23 to 0.5
Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline Change of Normalized Composite Neurocognitive Test Score (Week 96)	0.37 total neurocognitive z-score Interval 0.19 to 0.55	0.34 total neurocognitive z-score Interval 0.21 to 0.47	0.38 total neurocognitive z-score Interval 0.23 to 0.52

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 24, 48, 72, and 96

Functional status scores were calculated based on the instrumental activities of daily living (IADLs) forms. IADL scores were calculated as the sum of the eight IADL tasks where the task scores were equal to 1 if a participant did not need assistance with the task and equal to 0 if a participant needed some level of help with the task. The maximum possible functional status score was 8, while the minimum possible functional status score was 0, with higher functional status scores indicating a higher level of functionality.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Functional Status Scores Change from Baseline in IADL Score (Week 24)	0.29 units on a scale Interval -0.04 to 0.61	0.43 units on a scale Interval 0.07 to 0.8	0.15 units on a scale Interval -0.19 to 0.49
Change in Functional Status Scores Change from Baseline in IADL Score (Week 48)	0.38 units on a scale Interval 0.12 to 0.64	0.45 units on a scale Interval 0.11 to 0.79	0.10 units on a scale Interval -0.16 to 0.36
Change in Functional Status Scores Change from Baseline in IADL Score (Week 72)	0.40 units on a scale Interval 0.09 to 0.7	0.30 units on a scale Interval -0.07 to 0.67	0.13 units on a scale Interval -0.12 to 0.39
Change in Functional Status Scores Change from Baseline in IADL Score (Week 96)	0.16 units on a scale Interval -0.21 to 0.53	0.28 units on a scale Interval -0.08 to 0.64	0.20 units on a scale Interval -0.13 to 0.53

SECONDARY outcome

Timeframe: Measured at Weeks 24, 48, and 96

Population: The analysis included all participants who started study treatment and had Plasma HIV-1 RNA measured at the scheduled study visits.

The number of participants with Plasma HIV-1 RNA greater than or equal to 50 copies/mL was assessed at each given time point.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=62 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=66 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL HIV RNA (Week 24)	3 Participants	1 Participants	1 Participants
Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL HIV RNA (Week 48)	3 Participants	0 Participants	1 Participants
Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL HIV RNA (Week 96)	1 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Measured at Weeks 24, 48, and 96

Population: The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits.

CD4+ T-cell counts were recorded at the given time point

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
CD4+ T-cell Counts CD4 Count (Week 48)	638 cells/mm^3 Interval 565.0 to 711.0	691 cells/mm^3 Interval 628.0 to 754.0	758 cells/mm^3 Interval 669.0 to 846.0
CD4+ T-cell Counts CD4 Count (Week 96)	674 cells/mm^3 Interval 597.0 to 750.0	720 cells/mm^3 Interval 648.0 to 793.0	788 cells/mm^3 Interval 696.0 to 881.0
CD4+ T-cell Counts CD4 Count (Week 24)	660 cells/mm^3 Interval 585.0 to 735.0	669 cells/mm^3 Interval 610.0 to 727.0	773 cells/mm^3 Interval 676.0 to 869.0

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 24, 48, and 96

Population: The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits.

Changes in CD4+ T-cell count were calculated as the CD4+ T-cell count at a given time point minus the CD4+ T-cell count at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in CD4+ T-cell Count Change from Baseline in CD4 Count (Week 24)	-13 cells/mm^3 Interval -56.0 to 31.0	-33 cells/mm^3 Interval -66.0 to -1.0	42 cells/mm^3 Interval -19.0 to 103.0
Change in CD4+ T-cell Count Change from Baseline in CD4 Count (Week 48)	-43 cells/mm^3 Interval -82.0 to -5.0	-19 cells/mm^3 Interval -61.0 to 23.0	21 cells/mm^3 Interval -28.0 to 69.0
Change in CD4+ T-cell Count Change from Baseline in CD4 Count (Week 96)	-10 cells/mm^3 Interval -54.0 to 33.0	10 cells/mm^3 Interval -36.0 to 55.0	44 cells/mm^3 Interval -23.0 to 111.0

SECONDARY outcome

Timeframe: Measured at Weeks 24, 48, and 96

Population: The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits.

CD8+ T-cell counts were recorded at the given time point

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
CD8+ T-cell Counts CD8 Count (Week 24)	757 cells/mm^3 Interval 684.0 to 830.0	752 cells/mm^3 Interval 671.0 to 833.0	862 cells/mm^3 Interval 748.0 to 976.0
CD8+ T-cell Counts CD8 Count (Week 48)	742 cells/mm^3 Interval 655.0 to 828.0	731 cells/mm^3 Interval 648.0 to 814.0	856 cells/mm^3 Interval 759.0 to 954.0
CD8+ T-cell Counts CD8 Count (Week 96)	747 cells/mm^3 Interval 664.0 to 830.0	773 cells/mm^3 Interval 671.0 to 876.0	879 cells/mm^3 Interval 776.0 to 983.0

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 24, 48, and 96

Population: The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits.

Changes in CD8+ T-cell count were calculated as the CD8+ T-cell count at a given time point minus the CD8+ T-cell count at baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=63 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=67 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=60 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in CD8+ T-cell Count Change from Baseline in CD8 Count (Week 48)	-45 cells/mm^3 Interval -111.0 to 22.0	-82 cells/mm^3 Interval -133.0 to -31.0	35 cells/mm^3 Interval -32.0 to 103.0
Change in CD8+ T-cell Count Change from Baseline in CD8 Count (Week 24)	-29 cells/mm^3 Interval -83.0 to 24.0	-61 cells/mm^3 Interval -102.0 to -19.0	44 cells/mm^3 Interval -24.0 to 112.0
Change in CD8+ T-cell Count Change from Baseline in CD8 Count (Week 96)	-43 cells/mm^3 Interval -97.0 to 12.0	-33 cells/mm^3 Interval -87.0 to 21.0	44 cells/mm^3 Interval -31.0 to 118.0

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48.

Changes in Log10 sCD14 in Plasma were calculated as the Log10 sCD14 in Plasma at Week 48 minus the Log10 sCD14 in Plasma at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=54 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=54 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=54 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 sCD14 in Plasma at Week 48 From Baseline	0.04 Log10 ng/mL Interval 0.0 to 0.08	0.03 Log10 ng/mL Interval -0.01 to 0.07	0.01 Log10 ng/mL Interval -0.03 to 0.04

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48

Changes in Log10 MIP-1 Beta in Plasma were calculated as the Log10 MIP-1 Beta in Plasma at Week 48 minus the Log10 MIP-1 Beta in Plasma at Baseline. Results below the lower limit of quantification were set to the lower limit value of 11.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=54 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=54 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=54 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline	0.05 Log10 pg/mL Interval -0.04 to 0.14	-0.02 Log10 pg/mL Interval -0.1 to 0.06	0.30 Log10 pg/mL Interval 0.22 to 0.37

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48

Changes in Log10 sTNFr-II in Plasma were calculated as the Log10 sTNFr-II in Plasma at Week 48 minus the Log10 sTNFr-II in Plasma at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=54 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=54 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=54 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline	0.02 Log10 pg/mL Interval -0.02 to 0.05	0.01 Log10 pg/mL Interval -0.02 to 0.04	0.00 Log10 pg/mL Interval -0.04 to 0.03

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48

Changes in Log10 VCAM in Plasma were calculated as the Log10 VCAM in Plasma at Week 48 minus the Log10 VCAM in Plasma at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=54 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=54 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=54 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 VCAM in Plasma at Week 48 From Baseline	0.01 Log10 pg/mL Interval -0.02 to 0.05	0.00 Log10 pg/mL Interval -0.02 to 0.03	0.00 Log10 pg/mL Interval -0.03 to 0.02

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48

Changes in Log10 MIP-1 Beta in CSF were calculated as the Log10 MIP-1 Beta in CSF at Week 48 minus the Log10 MIP-1 Beta in CSF at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=13 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=12 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=9 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline	-0.24 Log10 pg/mL Interval -0.71 to 0.23	-0.32 Log10 pg/mL Interval -0.77 to 0.14	0.17 Log10 pg/mL Interval -0.42 to 0.76

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48

Changes in Log10 IP-10 in CSF were calculated as the Log10 IP-10 in CSF at Week 48 minus the Log10 IP-10 in CSF at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=13 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=12 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=9 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 IP-10 in CSF at Week 48 From Baseline	0.02 Log10 pg/mL Interval -0.06 to 0.09	-0.11 Log10 pg/mL Interval -0.33 to 0.1	-0.36 Log10 pg/mL Interval -0.99 to 0.26

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48

Changes in Log10 Neopterin in CSF were calculated as the Log10 Neopterin in CSF at Week 48 minus the Log10 Neopterin in CSF at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=13 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=12 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=9 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 Neopterin in CSF at Week 48 From Baseline	0.01 Log10 nmol/L Interval -0.04 to 0.06	-0.06 Log10 nmol/L Interval -0.22 to 0.1	-0.17 Log10 nmol/L Interval -0.51 to 0.17

SECONDARY outcome

Timeframe: Measured at Baseline and Week 48

Population: The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48

Changes in Log10 NFL in CSF were calculated as the Log10 NFL in CSF at Week 48 minus the Log10 NFL in CSF at Baseline.

Outcome measures

Outcome measures
Measure	Arm A: Placebo MVC and Placebo DTG n=13 Participants In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B: DTG and Placebo MVC n=12 Participants In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C: MVC and DTG n=9 Participants In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Change in Log10 NFL in CSF at Week 48 From Baseline	-0.02 Log10 pg/mL Interval -0.08 to 0.05	-0.05 Log10 pg/mL Interval -0.12 to 0.02	0.00 Log10 pg/mL Interval -0.14 to 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Baseline and Week 48

This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Baseline and Week 48

This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Baseline and Week 48

This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Placebo DTG/Placebo MVC)

Serious events: 6 serious events

Other events: 31 other events

Deaths: 1 deaths

Arm B (DTG/Placebo MVC)

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

Arm C (DTG/MVC)

Serious events: 9 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company

Phone: (301) 628-3348

Email: [email protected]

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

Serious adverse events
Measure	Arm A (Placebo DTG/Placebo MVC) n=63 participants at risk In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B (DTG/Placebo MVC) n=67 participants at risk In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C (DTG/MVC) n=60 participants at risk In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Infections and infestations Appendicitis perforated	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Cardiac disorders Atrial fibrillation	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Cardiac disorders Coronary artery stenosis	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Cardiac disorders Hypertensive heart disease	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Endocrine disorders Hyperthyroidism	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Gastrointestinal disorders Abdominal pain	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
General disorders Chest pain	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Anal abscess	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Pneumonia	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Sepsis	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Staphylococcal infection	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Urinary tract infection	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Wound infection	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Aspartate aminotransferase increased	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood bilirubin increased	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Nervous system disorders Haemorrhagic stroke	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Nervous system disorders Loss of consciousness	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Nervous system disorders Syncope	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Psychiatric disorders Suicide attempt	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Renal and urinary disorders Acute kidney injury	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	3.0% 2/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Asthma	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Vascular disorders Peripheral artery occlusion	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.

Other adverse events
Measure	Arm A (Placebo DTG/Placebo MVC) n=63 participants at risk In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Placebo for dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm B (DTG/Placebo MVC) n=67 participants at risk In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. Placebo for maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen	Arm C (DTG/MVC) n=60 participants at risk In addition to their existing ART regimens, participants in Arm C received MVC and DTG Dolutegravir (DTG): Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen Maraviroc (MVC): Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
Gastrointestinal disorders Nausea	3.2% 2/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	4.5% 3/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
General disorders Chest pain	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.7% 4/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
General disorders Fatigue	3.2% 2/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.0% 4/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	3.3% 2/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
General disorders Pain	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
General disorders Pyrexia	4.8% 3/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.0% 4/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Infections and infestations Influenza	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	3.0% 2/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Alanine aminotransferase increased	6.3% 4/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	4.5% 3/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Aspartate aminotransferase increased	7.9% 5/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood alkaline phosphatase increased	9.5% 6/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	9.0% 6/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	8.3% 5/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood bicarbonate decreased	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	3.0% 2/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood bilirubin increased	4.8% 3/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	10.4% 7/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	8.3% 5/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood creatinine increased	4.8% 3/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	13.4% 9/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	25.0% 15/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood glucose increased	12.7% 8/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	11.9% 8/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	16.7% 10/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood phosphorus decreased	9.5% 6/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.0% 4/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	3.3% 2/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood potassium decreased	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Blood sodium increased	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Investigations Creatinine renal clearance decreased	3.2% 2/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	9.0% 6/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	8.3% 5/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 3/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	0.00% 0/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	4.5% 3/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	5.0% 3/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 4/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	10.4% 7/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	8.3% 5/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.7% 4/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.9% 5/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	4.5% 3/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.7% 1/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/63 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	1.5% 1/67 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.	6.7% 4/60 • From treatment initiation to study completion at Week 96 or premature study discontinuation Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥ Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V2.1) and Expediated Adverse Events (EAE) Manual (V2.0) were used. All eligible participants who initiated study treatment are included.