Integrase and Maraviroc Intensification in Neurocognitive... | NCT02519777

ID	Type	Description	Link
11909	Registry Identifier	DAIDS-ES

Label	Type	Description	Intervention Names
Arm A: Placebo MVC and placebo DTG	Placebo Comparator	In addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.	Drug: Placebo for maraviroc (MVC) Drug: Placebo for dolutegravir (DTG)
Arm B: DTG and placebo MVC	Experimental	In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.	Drug: Placebo for maraviroc (MVC) Drug: Dolutegravir (DTG)
Arm C: MVC and DTG	Experimental	In addition to their existing ART regimens, participants in Arm C received MVC and DTG	Drug: Dolutegravir (DTG) Drug: Maraviroc (MVC)

Name	Type	Description	Arm Group Labels	Other Names
Placebo for maraviroc (MVC)	Drug	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	Arm A: Placebo MVC and placebo DTG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline	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.	Measured at Baseline and Week 48

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Related Adverse Events (AEs)	Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment.	Measured from treatment initiation through Week 96
Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline

Other Outcomes

Measure	Description	Time Frame
Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA)	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.	Measured at Baseline and Week 48
Changes in T Cell and Monocyte Activation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infection, documented by:
- a licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. NOTE: The term "licensed" refers to a United States Food and Drug Administration (FDA)-approved kit, which is required for all IND studies, or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally. Non-US sites are encouraged to use US FDA-approved methods for IND studies. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA. OR
- Documentation of HIV diagnosis in the medical record by a healthcare provider.
On current ART for at least 6 months prior to study entry with no interruption in treatment of greater than or equal to 7 consecutive days. Note: The following ART changes are allowed:
- Tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide fumarate (TAF)/TAF-containing fixed-dose combination regimens
- Ritonavir (RTV) to cobicistat (COBI)/COBI-containing fixed-dose combination regimens
No plans to change ART while on study. Note: The following planned ART changes are allowed:
- TDF to TAF/TAF-containing fixed-dose combination regimens
- RTV to COBI/COBI-containing fixed-dose combination regimens
HIV-1 plasma RNA less than 50 copies/mL obtained within 90 days prior to study entry by any FDA-approved assay at any United States laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
No more than one HIV-1 plasma RNA greater than or equal to 50 and less than 200 copies/mL (only one "blip") in the past 6 months with a subsequent HIV-1 plasma RNA less than 50 copies/mL. NOTE: There should be no plasma HIV-1 RNA greater than 200 copies/mL within the 6 months prior to study entry.
HAND diagnosis (ANI, MND, or HAD) within 60 days prior to study entry. HAND is defined as at least mild impairment on neurocognitive testing (more than one standard deviation below appropriate normative data in two domains of functioning) and no severely confounding factors.
Screening laboratory values obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs:
- Absolute neutrophil count (ANC) greater than or equal to 500/mm^3
- Hemoglobin greater than or equal to 7.5 g/dL
- Platelet count greater than or equal to 40,000/mm^3
- Creatinine less than or equal to 2.0 x upper limit of normal (ULN)
- Aspartate transaminase (AST) less than or equal to 5 x ULN
- Alanine transaminase (ALT) less than 3 x ULN
- Alkaline phosphatase less than or equal to 5 x ULN
- Total bilirubin less than 1.5 x ULN. NOTE: If the potential participant is taking an indinavir (IDV)- or atazanavir (ATV)-containing regimen at the time of screening, total bilirubin less than or equal to 5 x ULN is acceptable.
- Creatinine clearance (CrCl) greater than or equal to 60 mL/min, either measured or estimated by Cockcroft-Gault equation. NOTE: A calculator for estimating the CrCl can be found at www.fstrf.org/ACTG/ccc.html
Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, hysterectomy or bilateral salpingectomy or bilateral oophorectomy or tubal ligation) must have a negative serum or urine pregnancy test by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC) / CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs within 48 hours prior to study entry
Females of reproductive potential must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must use at least one reliable form of contraception. Female participants must use contraceptives while receiving study treatment and for 6 weeks after stopping study treatment. More information on this criterion is available in the protocol.
Ability and willingness of participant to complete the neuropsychological tests
Ability and willingness of participant or a legally authorized representative (see protocol for more information) to provide informed consent
Ability and willingness to take oral study medications

Exclusion Criteria:

Current or past medical condition(s) that in the opinion of the investigator prevents attribution of the cause of cognitive impairment to HIV. For example:
- Major depressive disorder with psychotic features
- Traumatic Brain Injury (TBI) with a clear impact on activities of daily living
- Developmental delay, intellectual deficit, and/or severe educational disability resulting in some dependence for activities of daily living
- Ongoing substance use disorder with significant impact on activities of daily living. Difficult or impossible to determine whether cognitive or functional decline is due to substance use or HIV, or both
- Evidence of intoxication or withdrawal during the screening evaluation
- Central nervous system (CNS) infections or opportunistic conditions: brain abscess (bacterial, mycobacterial, fungal or Toxoplasma), meningitis with persistent neurologic impairment, primary CNS lymphoma, progressive multifocal leukoencephalopathy (PML), or another structural brain lesion with neurological sequelae
- Other CNS conditions: non-opportunistic primary or metastatic brain tumors, uncontrolled seizure disorder, progressive multiple sclerosis, stroke with neurological sequelae, or dementia due to causes other than HIV (eg, Alzheimer's disease)
- Constitutional illness (eg, persistent unexplained fever, diarrhea, significant weight loss, disabling weakness) within 30 days of screening
- Known untreated B12 deficiency or malnutrition (body mass index [BMI] less than 18) at screening
Evidence of current hepatitis C virus infection (HCV) (ie, HCV antibody [Ab] positive within 90 days prior to study entry unless also shown to be plasma HCV RNA negative within the same time period)
Unstable and advanced liver disease (as defined by the presence of at least one of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice)
Prior or current use of any CCR5 antagonist (such as MVC and cenicriviroc [CVC]) and integrase inhibitor (such as RAL, DTG, and elvitegravir [EVG])
Current use of any medication, including antiretrovirals, prohibited in the study (refer to the A5324 protocol-specific web page [PSWP] for the prohibited medications)
Breastfeeding
Presence of an AIDS-defining opportunistic infection within 6 months prior to entry. Note: Refer to the A5324 Manual of Operations (MOPS) for the list of AIDS-defining opportunistic infections.
Active syphilis or treatment for syphilis within 90 days prior to study entry. NOTE: Active syphilis is defined as four-fold increase in serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL) tests in an individual with past syphilis, or newly reactive serum RPR or VDRL with a reactive confirmatory test (enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS]).
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation

Name	Affiliation	Role
Kevin Robertson, PhD	University of North Carolina	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UCLA CARE Center CRS		Los Angeles	California	90035	United States
UCSD Antiviral Research Center CRS

Label	URL
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017	View source
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010	View source

ID	Title	Description
FG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form: Protocol V2.0	Aug 25, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline

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.

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.

Posted

Mean

95% Confidence Interval

total neurocognitive z-score

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units	Counts
Participants	OG00063 OG00167 OG00260

Title

Denominators

Categories

Title	Measurements
	OG0000.20(0.02 to 0.37) OG0010.26(0.11 to 0.40) OG0020.31(0.16 to 0.46)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline	t-test, 2 sided		0.60														Superiority
OG000 OG002

Secondary

Number of Participants With Treatment Related Adverse Events (AEs)

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

All participants who were randomized were included in the analysis

Posted

Count of Participants

Participants

Measured from treatment initiation through Week 96

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline

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

Posted

Mean

95% Confidence Interval

total neurocognitive z-score

Measured at Baseline and Weeks 24, 72, and 96

ID	Title	Description
OG000	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

Secondary

Change in Functional Status Scores

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.

Posted

Mean

95% Confidence Interval

units on a scale

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL

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

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

Posted

Count of Participants

Participants

Measured at Weeks 24, 48, and 96

ID	Title	Description
OG000	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
OG001	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
OG002

Secondary

CD4+ T-cell Counts

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

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

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Weeks 24, 48, and 96

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in CD4+ T-cell Count

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.

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

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Baseline and Weeks 24, 48, and 96

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

CD8+ T-cell Counts

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

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

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Weeks 24, 48, and 96

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in CD8+ T-cell Count

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.

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

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Baseline and Weeks 24, 48, and 96

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Log10 sCD14 in Plasma at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 ng/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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

Secondary

Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002

Secondary

Change in Log10 VCAM in Plasma at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002

Secondary

Change in Log10 IP-10 in CSF at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Log10 Neopterin in CSF at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 nmol/L

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Secondary

Change in Log10 NFL in CSF at Week 48 From Baseline

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.

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

Posted

Mean

95% Confidence Interval

Log10 pg/mL

Measured at Baseline and Week 48

ID	Title	Description
OG000	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
OG001	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
OG002	Arm C: MVC and DTG

Other Pre-specified

Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA)

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.

Not Posted

Measured at Baseline and Week 48

Participants

Other Pre-specified

Changes in T Cell and Monocyte Activation

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.

Not Posted

Measured at Baseline and Week 48

Participants

Other Pre-specified

Changes in Residual Viremia

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.

Not Posted

Measured at Baseline and Week 48

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Anal abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Appendicitis perforated	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Staphylococcal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0020 affected60 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Loss of consciousness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Suicide attempt	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0021 affected60 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0012 affected67 at risk EG0020 affected60 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0021 affected60 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0020 affected60 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected63 at risk EG0013 affected67 at risk EG0023 affected60 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0024 affected60 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected63 at risk EG0014 affected67 at risk EG0022 affected60 at risk
Pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0023 affected60 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected63 at risk EG0014 affected67 at risk EG0023 affected60 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0012 affected67 at risk EG0023 affected60 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 affected63 at risk EG0013 affected67 at risk EG0023 affected60 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0005 affected63 at risk EG0010 affected67 at risk EG0023 affected60 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0006 affected63 at risk EG0016 affected67 at risk EG0025 affected60 at risk
Blood bicarbonate decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0012 affected67 at risk EG0023 affected60 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 affected63 at risk EG0017 affected67 at risk EG0025 affected60 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 affected63 at risk EG0019 affected67 at risk EG00215 affected60 at risk
Blood glucose increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0008 affected63 at risk EG0018 affected67 at risk EG00210 affected60 at risk
Blood phosphorus decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0006 affected63 at risk EG0014 affected67 at risk EG0022 affected60 at risk
Blood potassium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0010 affected67 at risk EG0023 affected60 at risk
Blood sodium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0023 affected60 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected63 at risk EG0016 affected67 at risk EG0025 affected60 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected63 at risk EG0010 affected67 at risk EG0023 affected60 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0010 affected67 at risk EG0023 affected60 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0013 affected67 at risk EG0023 affected60 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected63 at risk EG0017 affected67 at risk EG0025 affected60 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected63 at risk EG0011 affected67 at risk EG0024 affected60 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected63 at risk EG0013 affected67 at risk EG0021 affected60 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected63 at risk EG0011 affected67 at risk EG0024 affected60 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A (Placebo DTG/Placebo MVC)	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	1	63	6	63	31	63
EG001	Arm B (DTG/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	0	67	12	67	32	67
EG002	Arm C (DTG/MVC)	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	0	60	9	60	37	60