Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT02519777
Collaborator
(none)
191
30
3
56.5
6.4
0.1
Study Details
Study Description
Brief Summary
People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV] medications) to participants' existing ART regimens improved participants' neurocognitive performance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
HIV-infected people often have cognitive dysfunction (HIV-associated neurocognitive disorder, or HAND), which includes asymptomatic neurocognitive impairment (ANI), mild neurocognitive disorder (MND), and HIV-associated dementia (HAD), even if they are on ART and have undetectable viral loads. In this study, researchers evaluated the effectiveness of adding MVC and DTG to the current ART regimen of HIV-infected people with undetectable (<50 copies/mL) plasma HIV-1 RNA who had neurocognitive impairment and who had been on stable ART for at least 6 months prior to study entry. The purpose of this study was to evaluate if the addition of MVC and DTG to participants' existing ART regimens improved participants' neurocognitive performance.
Participants were randomly assigned to one of three arms. All participants remained on their existing ART regimens; they took their assigned study drugs in addition to their ART regimen. Study visits occurred at entry and Weeks 2, 4, 12, 24, 48, 72, and 96. Visits may have included physical examinations, blood collection, neurocognitive testing, pregnancy testing, and questionnaires. Some participants may have had an optional lumbar puncture procedure at study entry and Week 48. Participants returned for refills of study drugs on Weeks 36, 60, and 84.
Study Design
Study Type:
Interventional
Actual Enrollment
:
191 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
Actual Study Start Date
:
Apr 21, 2016
Actual Primary Completion Date
:
Dec 2, 2019
Actual Study Completion Date
:
Jan 5, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 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. |
Drug: 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
Drug: Placebo for dolutegravir (DTG)
Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
|
| Experimental: Arm B: DTG and placebo MVC In addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC. |
Drug: 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
Drug: Dolutegravir (DTG)
Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
|
| Experimental: Arm C: MVC and DTG In addition to their existing ART regimens, participants in Arm C received MVC and DTG |
Drug: Dolutegravir (DTG)
Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline [Measured at Baseline and Week 48]
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.
Secondary Outcome Measures
- Number of Participants With Treatment Related Adverse Events (AEs) [Measured from treatment initiation through Week 96]
Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment.
- Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline [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.
- Change in Functional Status Scores [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.
- Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL [Measured at Weeks 24, 48, and 96]
The number of participants with Plasma HIV-1 RNA greater than or equal to 50 copies/mL was assessed at each given time point.
- CD4+ T-cell Counts [Measured at Weeks 24, 48, and 96]
CD4+ T-cell counts were recorded at the given time point
- Change in CD4+ T-cell Count [Measured at Baseline and Weeks 24, 48, and 96]
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.
- CD8+ T-cell Counts [Measured at Weeks 24, 48, and 96]
CD8+ T-cell counts were recorded at the given time point
- Change in CD8+ T-cell Count [Measured at Baseline and Weeks 24, 48, and 96]
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.
- Change in Log10 sCD14 in Plasma at Week 48 From Baseline [Measured 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.
- Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline [Measured 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.
- Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline [Measured 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.
- Change in Log10 VCAM in Plasma at Week 48 From Baseline [Measured 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.
- Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline [Measured 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.
- Change in Log10 IP-10 in CSF at Week 48 From Baseline [Measured 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.
- Change in Log10 Neopterin in CSF at Week 48 From Baseline [Measured 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.
- Change in Log10 NFL in CSF at Week 48 From Baseline [Measured 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.
Other Outcome Measures
- Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA) [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.
- Changes in T Cell and Monocyte Activation [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.
- Changes in Residual Viremia [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA CARE Center CRS | Los Angeles | California | United States | 90035 |
| 2 | UCSD Antiviral Research Center CRS | San Diego | California | United States | 92103 |
| 3 | Harbor-UCLA CRS | Torrance | California | United States | 90502 |
| 4 | Whitman-Walker Health CRS | Washington | District of Columbia | United States | 20005 |
| 5 | Northwestern University CRS | Chicago | Illinois | United States | 60611 |
| 6 | Johns Hopkins University CRS | Baltimore | Maryland | United States | 21205 |
| 7 | Washington University Therapeutics (WT) CRS | Saint Louis | Missouri | United States | 63110-1010 |
| 8 | New Jersey Medical School Clinical Research Center CRS | Newark | New Jersey | United States | 07103 |
| 9 | Weill Cornell Chelsea CRS | New York | New York | United States | 10010 |
| 10 | Weill Cornell Uptown CRS | New York | New York | United States | 10065 |
| 11 | University of Rochester Adult HIV Therapeutic Strategies Network CRS | Rochester | New York | United States | 14642 |
| 12 | Chapel Hill CRS | Chapel Hill | North Carolina | United States | 27599 |
| 13 | Greensboro CRS | Greensboro | North Carolina | United States | 27401 |
| 14 | Cincinnati Clinical Research Site | Cincinnati | Ohio | United States | 45219 |
| 15 | Case Clinical Research Site | Cleveland | Ohio | United States | 44106 |
| 16 | Ohio State University CRS | Columbus | Ohio | United States | 43210 |
| 17 | Penn Therapeutics, CRS | Philadelphia | Pennsylvania | United States | 19104 |
| 18 | University of Pittsburgh CRS | Pittsburgh | Pennsylvania | United States | 15213 |
| 19 | The Miriam Hospital Clinical Research Site (TMH CRS) CRS | Providence | Rhode Island | United States | 02906 |
| 20 | Vanderbilt Therapeutics (VT) CRS | Nashville | Tennessee | United States | 37204 |
| 21 | Trinity Health and Wellness Center CRS | Dallas | Texas | United States | 75208 |
| 22 | Houston AIDS Research Team CRS | Houston | Texas | United States | 77030 |
| 23 | University of Washington AIDS CRS | Seattle | Washington | United States | 98104-9929 |
| 24 | Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Rio De Janeiro | Brazil | 21040-360 | |
| 25 | Puerto Rico AIDS Clinical Trials Unit CRS | San Juan | Puerto Rico | 00935 | |
| 26 | Wits Helen Joseph Hospital CRS (Wits HJH CRS) | Johannesburg | Gauteng | South Africa | 2092 |
| 27 | Durban International Clinical Research Site CRS | Durban | Kwa Zulu Natal | South Africa | 4052 |
| 28 | Famcru Crs | Tygerberg | Western Cape Province | South Africa | 7505 |
| 29 | Thai Red Cross AIDS Research Centre (TRC-ARC) CRS | Bangkok | Thailand | 10330 | |
| 30 | Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS | Chiang Mai | Thailand | 50200 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Study Chair: Kevin Robertson, PhD, University of North Carolina
Study Documents (Full-Text)
- Study Protocol and Informed Consent Form: Protocol V2.0 - Aug 25, 2017
- Study Protocol: Protocol V2.0_Letter of Amendment 1 - Mar 29, 2018
- Study Protocol: Protocol V2.0_Letter of Amendment 2 - Jun 4, 2018
- Study Protocol: Protocol V2.0_Letter of Amendment 3 - Aug 22, 2018
- Study Protocol: Protocol V2.0_Letter of Amendment 4 - Oct 23, 2020
- Statistical Analysis Plan - Feb 12, 2021
More Information
Additional Information:
- 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
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Publications
None provided.Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02519777
Other Study ID Numbers:
- A5324
- 11909
- NCT02406196
First Posted:
Aug 11, 2015
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 30 Clinical Research Sites (CRSs) in the United States, Thailand, Brazil, and South Africa between April 2016 and November 2018. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Period Title: Overall Study | |||
| STARTED | 63 | 67 | 61 |
| COMPLETED | 57 | 59 | 57 |
| NOT COMPLETED | 6 | 8 | 4 |
Baseline Characteristics
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 of all reporting groups |
| Overall Participants | 63 | 67 | 61 | 191 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
52
(7)
|
52
(9)
|
52
(8)
|
52
(8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
23.8%
|
23
34.3%
|
18
29.5%
|
56
29.3%
|
| Male |
48
76.2%
|
44
65.7%
|
43
70.5%
|
135
70.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
15
23.8%
|
17
25.4%
|
10
16.4%
|
42
22%
|
| Not Hispanic or Latino |
48
76.2%
|
50
74.6%
|
51
83.6%
|
149
78%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
1.6%
|
0
0%
|
0
0%
|
1
0.5%
|
| Asian |
5
7.9%
|
6
9%
|
6
9.8%
|
17
8.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
30
47.6%
|
30
44.8%
|
37
60.7%
|
97
50.8%
|
| White |
23
36.5%
|
29
43.3%
|
16
26.2%
|
68
35.6%
|
| More than one race |
1
1.6%
|
1
1.5%
|
1
1.6%
|
3
1.6%
|
| Unknown or Not Reported |
3
4.8%
|
1
1.5%
|
1
1.6%
|
5
2.6%
|
| Normalized Neurocognitive Test Scores (total neurocognitive z-score) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [total neurocognitive z-score] |
-0.96
(0.79)
|
-0.97
(0.70)
|
-1.09
(0.70)
|
-1.00
(0.73)
|
| CD4 Cell Count (cells/mm^3) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cells/mm^3] |
681
(294)
|
703
(278)
|
726
(331)
|
703
(300)
|
| CD8 Cell Count (cells/mm^3) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cells/mm^3] |
789
(334)
|
809
(393)
|
816
(393)
|
805
(373)
|
| HIV RNA (Count of Participants) | ||||
| <50 copies/mL |
62
98.4%
|
64
95.5%
|
58
95.1%
|
184
96.3%
|
| ≥50 copies/mL |
1
1.6%
|
3
4.5%
|
3
4.9%
|
7
3.7%
|
Outcome Measures
| Title | Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| Mean (95% Confidence Interval) [total neurocognitive z-score] |
0.20
|
0.26
|
0.31
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Number of Participants With Treatment Related Adverse Events (AEs) |
|---|---|
| Description | Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment. |
| Time Frame | Measured from treatment initiation through Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized were included in the analysis |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 61 |
| Count of Participants [Participants] |
3
4.8%
|
5
7.5%
|
7
11.5%
|
| Title | Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Weeks 24, 72, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| Change of Normalized Composite Neurocognitive Test Score (Week 24) |
0.14
|
0.18
|
0.20
|
| Change of Normalized Composite Neurocognitive Test Score (Week 72) |
0.29
|
0.32
|
0.37
|
| Change of Normalized Composite Neurocognitive Test Score (Week 96) |
0.37
|
0.34
|
0.38
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.55 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.85 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Functional Status Scores |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Weeks 24, 48, 72, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| Change from Baseline in IADL Score (Week 24) |
0.29
|
0.43
|
0.15
|
| Change from Baseline in IADL Score (Week 48) |
0.38
|
0.45
|
0.10
|
| Change from Baseline in IADL Score (Week 72) |
0.40
|
0.30
|
0.13
|
| Change from Baseline in IADL Score (Week 96) |
0.16
|
0.28
|
0.20
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 functional status scores at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 functional status scores at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 functional status scores at Week 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 functional status scores at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.69 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.44 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL |
|---|---|
| Description | The number of participants with Plasma HIV-1 RNA greater than or equal to 50 copies/mL was assessed at each given time point. |
| Time Frame | Measured at Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis included all participants who started study treatment and had Plasma HIV-1 RNA measured at the scheduled study visits. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 62 | 66 | 60 |
| HIV RNA (Week 24) |
3
4.8%
|
1
1.5%
|
1
1.6%
|
| HIV RNA (Week 48) |
3
4.8%
|
0
0%
|
1
1.6%
|
| HIV RNA (Week 96) |
1
1.6%
|
6
9%
|
2
3.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | 3.32 | |
| Confidence Interval |
(2-Sided) 95% -2.78 to 9.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | 5.17 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 10.87 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | -8.21 | |
| Confidence Interval |
(2-Sided) 95% -16.56 to 0.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | 3.17 | |
| Confidence Interval |
(2-Sided) 95% -3.07 to 9.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | 3.48 | |
| Confidence Interval |
(2-Sided) 95% -3.11 to 10.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | -1.85 | |
| Confidence Interval |
(2-Sided) 95% -7.89 to 4.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -4.53 to 4.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | -1.69 | |
| Confidence Interval |
(2-Sided) 95% -4.99 to 1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentage of Participants |
| Estimated Value | 6.36 | |
| Confidence Interval |
(2-Sided) 95% -2.70 to 15.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | CD4+ T-cell Counts |
|---|---|
| Description | CD4+ T-cell counts were recorded at the given time point |
| Time Frame | Measured at Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| CD4 Count (Week 24) |
660
|
669
|
773
|
| CD4 Count (Week 48) |
638
|
691
|
758
|
| CD4 Count (Week 96) |
674
|
720
|
788
|
| Title | Change in CD4+ T-cell Count |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| Change from Baseline in CD4 Count (Week 24) |
-13
|
-33
|
42
|
| Change from Baseline in CD4 Count (Week 48) |
-43
|
-19
|
21
|
| Change from Baseline in CD4 Count (Week 96) |
-10
|
10
|
44
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD4+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD4+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD4+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.42 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.56 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | CD8+ T-cell Counts |
|---|---|
| Description | CD8+ T-cell counts were recorded at the given time point |
| Time Frame | Measured at Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| CD8 Count (Week 24) |
757
|
752
|
862
|
| CD8 Count (Week 48) |
742
|
731
|
856
|
| CD8 Count (Week 96) |
747
|
773
|
879
|
| Title | Change in CD8+ T-cell Count |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 63 | 67 | 60 |
| Change from Baseline in CD8 Count (Week 24) |
-29
|
-61
|
44
|
| Change from Baseline in CD8 Count (Week 48) |
-45
|
-82
|
35
|
| Change from Baseline in CD8 Count (Week 96) |
-43
|
-33
|
44
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD8+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.63 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD8+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.38 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 CD8+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.27 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.23 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.09 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.09 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 sCD14 in Plasma at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48. |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 54 | 54 |
| Mean (95% Confidence Interval) [Log10 ng/mL] |
0.04
|
0.03
|
0.01
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 sCD14 in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 54 | 54 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
0.05
|
-0.02
|
0.30
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 MIP-1 Beta in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.52 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 54 | 54 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
0.02
|
0.01
|
0.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 sTNFr-II in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.91 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 VCAM in Plasma at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 54 | 54 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
0.01
|
0.00
|
0.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 VCAM in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.85 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 13 | 12 | 9 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
-0.24
|
-0.32
|
0.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 MIP-1 Beta in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 IP-10 in CSF at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 13 | 12 | 9 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
0.02
|
-0.11
|
-0.36
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 IP-10 in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 Neopterin in CSF at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 13 | 12 | 9 |
| Mean (95% Confidence Interval) [Log10 nmol/L] |
0.01
|
-0.06
|
-0.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 Neopterin in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in Log10 NFL in CSF at Week 48 From Baseline |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 |
| Arm/Group Title | Arm A: Placebo MVC and Placebo DTG | Arm B: DTG and Placebo MVC | Arm C: MVC and DTG |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 13 | 12 | 9 |
| Mean (95% Confidence Interval) [Log10 pg/mL] |
-0.02
|
-0.05
|
0.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm B: DTG and Placebo MVC |
|---|---|---|
| Comments | 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 Log10 NFL in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.52 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A: Placebo MVC and Placebo DTG, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B: DTG and Placebo MVC, Arm C: MVC and DTG |
|---|---|---|
| Comments | Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA) |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Changes in T Cell and Monocyte Activation |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Changes in Residual Viremia |
|---|---|
| Description | 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. |
| Time Frame | Measured at Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | From treatment initiation to study completion at Week 96 or premature study discontinuation | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Arm A (Placebo DTG/Placebo MVC) | Arm B (DTG/Placebo MVC) | Arm C (DTG/MVC) | |||
| Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
| Arm A (Placebo DTG/Placebo MVC) | Arm B (DTG/Placebo MVC) | Arm C (DTG/MVC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
Serious Adverse Events |
||||||
| Arm A (Placebo DTG/Placebo MVC) | Arm B (DTG/Placebo MVC) | Arm C (DTG/MVC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/63 (9.5%) | 12/67 (17.9%) | 9/60 (15%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Coronary artery stenosis | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Hypertensive heart disease | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Endocrine disorders | ||||||
| Hyperthyroidism | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| General disorders | ||||||
| Chest pain | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Infections and infestations | ||||||
| Anal abscess | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Appendicitis perforated | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Pneumonia | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Sepsis | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Staphylococcal infection | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Urinary tract infection | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Wound infection | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Foot fracture | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Tendon injury | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Investigations | ||||||
| Aspartate aminotransferase increased | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Blood bilirubin increased | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Adenocarcinoma of colon | 1/63 (1.6%) | 0/67 (0%) | 0/60 (0%) | |||
| Anal squamous cell carcinoma | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| B-cell lymphoma | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Ovarian cancer | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Plasma cell myeloma | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Nervous system disorders | ||||||
| Haemorrhagic stroke | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Loss of consciousness | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Syncope | 0/63 (0%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Psychiatric disorders | ||||||
| Suicide attempt | 0/63 (0%) | 1/67 (1.5%) | 1/60 (1.7%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/63 (0%) | 2/67 (3%) | 0/60 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 1/63 (1.6%) | 0/67 (0%) | 1/60 (1.7%) | |||
| Chronic obstructive pulmonary disease | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
| Vascular disorders | ||||||
| Peripheral artery occlusion | 0/63 (0%) | 1/67 (1.5%) | 0/60 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Arm A (Placebo DTG/Placebo MVC) | Arm B (DTG/Placebo MVC) | Arm C (DTG/MVC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/63 (49.2%) | 32/67 (47.8%) | 37/60 (61.7%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 2/63 (3.2%) | 3/67 (4.5%) | 3/60 (5%) | |||
| General disorders | ||||||
| Chest pain | 0/63 (0%) | 0/67 (0%) | 4/60 (6.7%) | |||
| Fatigue | 2/63 (3.2%) | 4/67 (6%) | 2/60 (3.3%) | |||
| Pain | 0/63 (0%) | 1/67 (1.5%) | 3/60 (5%) | |||
| Pyrexia | 3/63 (4.8%) | 4/67 (6%) | 3/60 (5%) | |||
| Infections and infestations | ||||||
| Influenza | 1/63 (1.6%) | 2/67 (3%) | 3/60 (5%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 4/63 (6.3%) | 3/67 (4.5%) | 3/60 (5%) | |||
| Aspartate aminotransferase increased | 5/63 (7.9%) | 0/67 (0%) | 3/60 (5%) | |||
| Blood alkaline phosphatase increased | 6/63 (9.5%) | 6/67 (9%) | 5/60 (8.3%) | |||
| Blood bicarbonate decreased | 1/63 (1.6%) | 2/67 (3%) | 3/60 (5%) | |||
| Blood bilirubin increased | 3/63 (4.8%) | 7/67 (10.4%) | 5/60 (8.3%) | |||
| Blood creatinine increased | 3/63 (4.8%) | 9/67 (13.4%) | 15/60 (25%) | |||
| Blood glucose increased | 8/63 (12.7%) | 8/67 (11.9%) | 10/60 (16.7%) | |||
| Blood phosphorus decreased | 6/63 (9.5%) | 4/67 (6%) | 2/60 (3.3%) | |||
| Blood potassium decreased | 1/63 (1.6%) | 0/67 (0%) | 3/60 (5%) | |||
| Blood sodium increased | 0/63 (0%) | 0/67 (0%) | 3/60 (5%) | |||
| Creatinine renal clearance decreased | 2/63 (3.2%) | 6/67 (9%) | 5/60 (8.3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 3/63 (4.8%) | 0/67 (0%) | 3/60 (5%) | |||
| Back pain | 0/63 (0%) | 0/67 (0%) | 3/60 (5%) | |||
| Pain in extremity | 0/63 (0%) | 3/67 (4.5%) | 3/60 (5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 4/63 (6.3%) | 7/67 (10.4%) | 5/60 (8.3%) | |||
| Dyspnoea | 1/63 (1.6%) | 1/67 (1.5%) | 4/60 (6.7%) | |||
| Oropharyngeal pain | 5/63 (7.9%) | 3/67 (4.5%) | 1/60 (1.7%) | |||
| Wheezing | 0/63 (0%) | 1/67 (1.5%) | 4/60 (6.7%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
| Name/Title | ACTG Clinicaltrials.gov Coordinator |
|---|---|
| Organization | ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company |
| Phone | (301) 628-3348 |
| ACTGCT.gov@fstrf.org |
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02519777
Other Study ID Numbers:
- A5324
- 11909
- NCT02406196
First Posted:
Aug 11, 2015
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022