Trial of Maraviroc (UK-427,857) in Combination With Optim... | NCT00098722 | Trialant
NCT00098722
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
May 16, 2012Estimated
Enrollment
474Actual
Phase
Phase 2Phase 3
Conditions
HIV Infections
Interventions
Maraviroc (UK-427,857)
optimized background therapy
Maraviroc (UK-427,857)
optimized background therapy
optimized background therapy
Countries
United States
Australia
Belgium
Canada
France
Germany
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00098722
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4001028
Secondary IDs
Not provided
Brief Title
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
Acronym
MOTIVATE 2
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Apr 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2004
Primary Completion Date
Apr 2007Actual
Completion Date
Apr 2011Actual
First Submitted Date
Dec 7, 2004
First Submission Date that Met QC Criteria
Dec 7, 2004
First Posted Date
Dec 8, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 16, 2012
Results First Submitted that Met QC Criteria
Apr 16, 2012
Results First Posted Date
May 16, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 16, 2012
Last Update Posted Date
May 16, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
474Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: Maraviroc (UK-427,857)
Drug: optimized background therapy
2
Placebo Comparator
Drug: Maraviroc (UK-427,857)
Drug: optimized background therapy
3
Experimental
Drug: optimized background therapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Maraviroc (UK-427,857)
Drug
maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline and Week 24
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline and Week 48
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Week 24 and 48
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
Week 24 and 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men or women at least 16 yers of age (or minimum age as determined by local regulatory authorities)
HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL
Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks
Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide
Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
Effective barrier contraception for WOCBP and males
Exclusion Criteria:
Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days
Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up
Lactating women, or planned pregnancy during the trial period
Significant renal insufficiency
Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to randomization or the expected need for such therapy during the study period
Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
Significantly elevated liver enzymes or cirrhosis
Significant neutropenia, anemia or thrombocytopenia
Malabsorption or an inability to tolerate oral medications
Certain medications
Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
X4- or dual/mixed-tropic virus or repeated assay failure
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
[OBT (3-6 drugs based on treatment history and resistance testing)]
1
Selzentry
Maraviroc (UK-427,857)
Drug
maraviroc (UK-427,857) 150 mg taken twice daily
2
Selzentry
optimized background therapy
Drug
[OBT (3-6 drugs based on treatment history and resistance testing)]
2
optimized background therapy
Drug
[OBT (3-6 drugs based on treatment history and resistance testing)]
3
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
Week 24 and 48
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Week 24 and 48
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Baseline
Change From Baseline in CD4 Cell Count at Week 24 and 48
Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Week 24 and 48
Change From Baseline in CD8 Cell Count at Week 24 and 48
Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Week 24 and 48
Time to Virological Failure
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
Week 48
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Baseline to Week 24 and Week 48
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening and time of failure through Week 24
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Screening and time of failure through Week 48
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
Baseline and time of failure through Week 24
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
Baseline and time of failure through Week 48
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.
Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.
Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.
FG001
Maraviroc BID, Double Blind
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
FG002
Placebo, Double Blind
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
FG003
Maraviroc BID, Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
FG004
In Study-off Drug (ISOD), Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
FG005
Maraviroc BID, Observation Phase
Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
FG006
In Study-off Drug (ISOD), Observation Phase
Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
FG000186 subjects
FG001194 subjects
FG00294 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Treated
FG000182 subjects
FG001191 subjects
FG00291 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000186 subjects
FG001194 subjects
FG00294 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0017 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00021 subjects
FG00123 subjects
FG00215 subjects
FG0030 subjects
FG004
Participant defaulted
FG00016 subjects
FG00111 subjects
FG0029 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized, not treated
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG004
Ongoing at cut-off date
FG000128 subjects
FG001137 subjects
FG00257 subjects
FG0030 subjects
FG004
Other
FG0007 subjects
FG0018 subjects
FG0027 subjects
FG0030 subjects
FG004
Open Label Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003272 subjects
FG00450 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003272 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Observation Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005205 subjects
FG00665 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
BG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
BG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000182
BG001191
BG00291
BG003464
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Out of a total of 474 participants, data for baseline measure (age) was available for 464 participants who were treated.
Number
participants
Title
Denominators
Categories
Less than 18 years
Title
Measurements
BG0001
BG0010
BG0020
BG003
Sex: Female, Male
Out of a total of 474 participants, data for baseline measure (gender) was available for 464 participants who were treated.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00121
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.
Posted
Mean
Standard Deviation
log10 copies/milliliter(log10 copies/mL)
Baseline
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Title
Measurements
OG0004.873± 0.6641
OG0014.840± 0.6205
OG0024.886± 0.6957
Primary
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline and Week 24
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Primary
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Posted
Mean
Standard Deviation
cells per microliter (cells/μL)
Baseline
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Secondary
Change From Baseline in CD4 Cell Count at Week 24 and 48
Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Posted
Least Squares Mean
Standard Error
cells/μL
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Secondary
Change From Baseline in CD8 Cell Count at Week 24 and 48
Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.
Posted
Least Squares Mean
Standard Error
cells/μL
Week 24 and 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Secondary
Time to Virological Failure
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
FAS included all the randomized participants who had taken at least one dose of the study medication.
Posted
Median
95% Confidence Interval
days
Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Baseline to Week 24 and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS included all the randomized participants who had taken at least one dose of the study medication.
Posted
Number
participants
Screening
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Posted
Number
participants
Screening and time of failure through Week 24
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.
Posted
Number
participants
Screening and time of failure through Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Posted
Number
participants
Baseline and time of failure through Week 24
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.
Posted
Number
participants
Baseline and time of failure through Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Secondary
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.
Posted
Mean
Standard Deviation
log10copies/mL
Baseline, Week 24 and Week 48
ID
Title
Description
OG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
OG001
Maraviroc BID
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Maraviroc QD
Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
40
182
138
182
EG001
Maraviroc BID
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
46
191
147
191
EG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
16
91
64
91
EG003
Maraviroc BID, Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
28
272
15
272
EG004
In Study-off Drug, Open Label
Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
0
50
0
50
EG005
Maraviroc BID, Observation Phase
Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
0
205
0
205
EG006
In Study-off Drug, Observation Phase
Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
0
65
0
65
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG0032 affected272 at risk
EG0040 affected50 at risk
EG0050 affected205 at risk
EG0060 affected65 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Supraventricular tachyarrhythmia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0012 affected191 at risk
EG0021 affected91 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected182 at risk
EG0012 affected191 at risk
EG0021 affected91 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected182 at risk
EG0013 affected191 at risk
EG0022 affected91 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Chest pain
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Hyperthermia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0012 affected191 at risk
EG0023 affected91 at risk
EG003
Mucosal erosion
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Sudden death
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0021 affected91 at risk
EG003
Immune reconstitution syndrome
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Anogenital warts
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Aspergillosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Genitourinary tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Herpes zoster disseminated
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Lung infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Malaria
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Mycobacterial infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0021 affected91 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0021 affected91 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Pneumocystis jiroveci pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0015 affected191 at risk
EG0021 affected91 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Pyothorax
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Septic shock
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Syphilis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0011 affected191 at risk
EG0021 affected91 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Metastatic salivary gland cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Paraganglion neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Demyelination
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Encephalitis
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0012 affected191 at risk
EG0021 affected91 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0012 affected191 at risk
EG0020 affected91 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0011 affected191 at risk
EG0022 affected91 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0021 affected91 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Lipohypertrophy
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Arterial bypass operation
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Osteotomy
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Haematoma
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected182 at risk
EG0010 affected191 at risk
EG0020 affected91 at risk
EG003
Iliac artery stenosis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0010 affected191 at risk
EG0021 affected91 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected182 at risk
EG0011 affected191 at risk
EG0020 affected91 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00013 affected182 at risk
EG00110 affected191 at risk
EG0025 affected91 at risk
EG0030 affected272 at risk
EG0040 affected50 at risk
EG0050 affected205 at risk
EG0060 affected65 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00015 affected182 at risk
EG0015 affected191 at risk
EG0024 affected91 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG00112 affected191 at risk
EG0026 affected91 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00049 affected182 at risk
EG00139 affected191 at risk
EG00219 affected91 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0009 affected182 at risk
EG0014 affected191 at risk
EG0027 affected91 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00039 affected182 at risk
EG00133 affected191 at risk
EG00217 affected91 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00024 affected182 at risk
EG00120 affected191 at risk
EG0029 affected91 at risk
EG003
Asthenia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00011 affected182 at risk
EG0018 affected191 at risk
EG0023 affected91 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00025 affected182 at risk
EG00122 affected191 at risk
EG00213 affected91 at risk
EG003
Injection site reaction
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected182 at risk
EG00113 affected191 at risk
EG0025 affected91 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00014 affected182 at risk
EG00126 affected191 at risk
EG0028 affected91 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00018 affected182 at risk
EG00118 affected191 at risk
EG0027 affected91 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG0018 affected191 at risk
EG0020 affected91 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00028 affected182 at risk
EG00127 affected191 at risk
EG0024 affected91 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00015 affected182 at risk
EG0018 affected191 at risk
EG0027 affected91 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG00020 affected182 at risk
EG00126 affected191 at risk
EG0025 affected91 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0007 affected182 at risk
EG0018 affected191 at risk
EG0026 affected91 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG00014 affected182 at risk
EG00115 affected191 at risk
EG0029 affected91 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG00114 affected191 at risk
EG0023 affected91 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00013 affected182 at risk
EG00110 affected191 at risk
EG0023 affected91 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG0017 affected191 at risk
EG0024 affected91 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00017 affected182 at risk
EG00111 affected191 at risk
EG0021 affected91 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG00017 affected182 at risk
EG00115 affected191 at risk
EG0028 affected91 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG00036 affected182 at risk
EG00130 affected191 at risk
EG00216 affected91 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0006 affected182 at risk
EG00111 affected191 at risk
EG0023 affected91 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG00114 affected191 at risk
EG0024 affected91 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected182 at risk
EG00116 affected191 at risk
EG0024 affected91 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00017 affected182 at risk
EG00128 affected191 at risk
EG0025 affected91 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0005 affected182 at risk
EG0016 affected191 at risk
EG0025 affected91 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG00012 affected182 at risk
EG00117 affected191 at risk
EG0025 affected91 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077592
Maraviroc
Ancestor Terms
ID
Term
D003510
Cyclohexanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
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Browse Branches
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0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
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FG0060 subjects
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0 subjects
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FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
50 subjects
FG0050 subjects
FG0060 subjects
5 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Participant defaulted
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00318 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Ongoing at cut-off date
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003220 subjects
FG00450 subjects
FG0050 subjects
FG0060 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00318 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG005160 subjects
FG00648 subjects
0 subjects
FG00545 subjects
FG00617 subjects
0 subjects
FG0040 subjects
FG0055 subjects
FG0063 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
Participant defaulted
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00517 subjects
FG0064 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00521 subjects
FG00610 subjects
1
18 to 24 years
Title
Measurements
BG0001
BG0011
BG0020
BG0032
25 to 34 years
Title
Measurements
BG0008
BG0019
BG0026
BG00323
35 to 44 years
Title
Measurements
BG00085
BG00171
BG00240
BG003196
45 to 54 years
Title
Measurements
BG00063
BG00170
BG00232
BG003165
55 to 64 years
Title
Measurements
BG00019
BG00137
BG00211
BG00367
Greater than or equal to 65 years
Title
Measurements
BG0005
BG0013
BG0022
BG00310
BG002
12
BG00362
Male
BG000153
BG001170
BG00279
BG003402
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Title
Measurements
OG000-1.950± 0.1054
OG001-1.971± 0.1026
OG002-0.929± 0.1473
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-1.021
Standard Error of the Mean
0.1802
2-Sided
97.5
-1.426
-0.616
No
Superiority or Other
OG001
OG002
The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-1.042
Standard Error of the Mean
0.1786
2-Sided
97.5
-1.444
-0.640
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Title
Measurements
OG000-1.718± 0.1086
OG001-1.865± 0.1057
OG002-0.757± 0.1518
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-0.961
Standard Error of the Mean
0.1856
2-Sided
97.5
-1.379
-0.544
No
Superiority or Other
OG001
OG002
The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.
LS mean difference
-1.109
Standard Error of the Mean
0.1840
2-Sided
97.5
-1.523
-0.695
No
Superiority or Other
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Week 24
Title
Measurements
OG00055.49
OG00161.26
OG00223.08
Week 48
Title
Measurements
OG00052.75
OG00154.97
OG00223.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than [<] 100,000 or greater than or equal to [>=] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (>) 1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.59
2-Sided
95
2.56
8.23
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
6.01
2-Sided
95
3.35
10.78
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.03
2-Sided
95
2.25
7.20
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.41
2-Sided
95
2.47
7.85
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Week 24
Title
Measurements
OG00069.78
OG00172.25
OG00237.36
Week 48
Title
Measurements
OG00060.99
OG00165.97
OG00231.87
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.69
2-Sided
95
2.72
8.10
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
5.01
2-Sided
95
2.91
8.62
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.67
2-Sided
95
2.13
6.32
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.64
2-Sided
95
2.69
8.02
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Week 24
Title
Measurements
OG00066.48
OG00169.63
OG00230.77
Week 48
Title
Measurements
OG00058.79
OG00163.35
OG00227.47
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.58
2-Sided
95
2.64
7.92
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
5.42
2-Sided
95
3.13
9.39
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.01
2-Sided
95
2.29
7.00
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
5.08
2-Sided
95
2.91
8.89
No
Superiority or Other
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Week 24
Title
Measurements
OG00045.60
OG00140.84
OG00220.88
Week 48
Title
Measurements
OG00045.05
OG00144.50
OG00217.58
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.55
2-Sided
95
1.95
6.48
No
Superiority or Other
OG001
OG002
Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio >1 favors maraviroc.
Regression, Logistic
0.0005
Odds Ratio (OR)
2.88
2-Sided
95
1.59
5.23
No
Superiority or Other
OG000
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.23
2-Sided
95
2.26
7.92
No
Superiority or Other
OG001
OG002
Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.
Regression, Logistic
<0.0001
Odds Ratio (OR)
4.10
2-Sided
95
2.20
7.64
No
Superiority or Other
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00290
Title
Denominators
Categories
CD4
Title
Measurements
OG000206.0± 171.99
OG001204.9± 149.21
OG002198.5± 140.39
CD8
Title
Measurements
OG000994.6± 658.03
OG001996.9± 576.97
OG002952.3± 598.19
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000180
OG001185
OG00290
Title
Denominators
Categories
Week 24
Title
Measurements
OG000111.72± 7.821
OG001101.89± 7.684
OG00263.78± 10.929
Week 48
Title
Measurements
OG000121.49± 8.651
OG001127.80± 8.499
OG00269.34± 12.088
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
47.94
Standard Error of the Mean
13.383
2-Sided
95
21.64
74.25
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
38.12
Standard Error of the Mean
13.313
2-Sided
95
11.96
64.28
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
52.15
Standard Error of the Mean
14.803
2-Sided
95
23.06
81.25
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
58.46
Standard Error of the Mean
14.725
2-Sided
95
29.53
87.40
No
Superiority or Other
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000180
OG001185
OG00290
Title
Denominators
Categories
Week 24
Title
Measurements
OG000340.74± 41.601
OG001255.40± 40.873
OG002122.18± 58.150
Week 48
Title
Measurements
OG000241.43± 33.789
OG001244.75± 33.198
OG002104.51± 47.231
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
218.57
Standard Error of the Mean
71.225
2-Sided
95
78.59
358.54
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
133.22
Standard Error of the Mean
70.855
2-Sided
95
-6.03
272.47
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
136.93
Standard Error of the Mean
57.850
2-Sided
95
23.24
250.62
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.
LS mean difference
140.25
Standard Error of the Mean
57.550
2-Sided
95
27.15
253.35
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Title
Measurements
OG000345.00(197.00 to NA)Upper limit of CI was not estimable because the empirical distribution rendered the algorithmic formula non-calculable.
OG001361.00(361.00 to NA)Upper limit of CI was not estimable because the empirical distribution rendered the algorithmic formula non-calculable.
OG0020.00(NA to NA)Data was not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Log Rank
<0.0001
Hazard Ratio (HR)
0.40
2-Sided
95
0.29
0.56
No
Superiority or Other
OG001
OG002
P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.
Log Rank
<0.0001
Hazard Ratio (HR)
0.33
2-Sided
95
0.23
0.46
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-1.748± 0.0897
OG001-1.755± 0.0873
OG002-0.872± 0.1254
Week 48
Title
Measurements
OG000-1.603± 0.0994
OG001-1.781± 0.0968
OG002-0.748± 0.1390
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.876
Standard Error of the Mean
0.1534
2-Sided
95
-1.177
-0.575
No
Superiority or Other
OG001
OG002
Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.882
Standard Error of the Mean
0.1521
2-Sided
95
-1.181
-0.584
No
Superiority or Other
OG000
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-0.855
Standard Error of the Mean
0.1700
2-Sided
95
-1.189
-0.521
No
Superiority or Other
OG001
OG002
Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.
LS mean difference
-1.033
Standard Error of the Mean
0.1685
2-Sided
95
-1.364
-0.701
No
Superiority or Other
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000182
OG001191
OG00291
Title
Denominators
Categories
GSS: 0
Title
Measurements
OG00039
OG00143
OG00220
GSS: 1
Title
Measurements
OG00064
OG00158
OG00224
GSS: 2
Title
Measurements
OG00025
OG00132
OG00220
GSS: greater than or equal to 3
Title
Measurements
OG00052
OG00157
OG00225
GSS: missing
Title
Measurements
OG0002
OG0011
OG0022
PSS: 0
Title
Measurements
OG00020
OG00126
OG00212
PSS: 1
Title
Measurements
OG00046
OG00142
OG00220
PSS: 2
Title
Measurements
OG00042
OG00138
OG00223
PSS: greater than or equal to 3
Title
Measurements
OG00071
OG00184
OG00234
PSS: missing
Title
Measurements
OG0003
OG0011
OG0022
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00027
OG00131
OG00244
Title
Denominators
Categories
Change in GSS by less than -3 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0011
OG0020
Change in GSS by -3 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by -2 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by -1 (n= 22, 25, 40)
Title
Measurements
OG0009
OG0016
OG00215
Change in GSS by 0 (n= 22, 25, 40)
Title
Measurements
OG00013
OG00115
OG00222
Change in GSS by 1 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0013
OG0021
Change in GSS by 2 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by 3 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by greater than 3 (n= 22, 25, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by less than -3 (n= 22, 24, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by -3 (n= 22, 24, 40)
Title
Measurements
OG0001
OG0010
OG0022
Change in PSS by -2 (n= 22, 24, 40)
Title
Measurements
OG0002
OG0013
OG0023
Change in PSS by -1 (n= 22, 24, 40)
Title
Measurements
OG0008
OG0018
OG00216
Change in PSS by 0 (n= 22, 24, 40)
Title
Measurements
OG00010
OG00113
OG00218
Change in PSS by 1 (n= 22, 24, 40)
Title
Measurements
OG0001
OG0010
OG0021
Change in PSS by 2 (n= 22, 24, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by 3 (n= 22, 24, 40)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by greater than 3 (n= 22, 24, 40)
Title
Measurements
OG0000
OG0010
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00041
OG00138
OG00249
Title
Denominators
Categories
Change in GSS by less than -3 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0011
OG0020
Change in GSS by -3 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by -2 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0010
OG0022
Change in GSS by -1 (n= 35, 33, 46)
Title
Measurements
OG00012
OG0016
OG00217
Change in GSS by 0 (n= 35, 33, 46)
Title
Measurements
OG00023
OG00122
OG00224
Change in GSS by 1 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0014
OG0022
Change in GSS by 2 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0010
OG0021
Change in GSS by 3 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0010
OG0020
Change in GSS by greater than 3 (n= 35, 33, 46)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by less than -3 (n= 35, 32, 46)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by -3 (n= 35, 32, 46)
Title
Measurements
OG0001
OG0010
OG0023
Change in PSS by -2 (n= 35, 32, 46)
Title
Measurements
OG0003
OG0013
OG0024
Change in PSS by -1 (n= 35, 32, 46)
Title
Measurements
OG00013
OG0019
OG00218
Change in PSS by 0 (n= 35, 32, 46)
Title
Measurements
OG00016
OG00119
OG00219
Change in PSS by 1 (n= 35, 32, 46)
Title
Measurements
OG0002
OG0010
OG0022
Change in PSS by 2 (n= 35, 32, 46)
Title
Measurements
OG0000
OG0011
OG0020
Change in PSS by 3 (n= 35, 32, 46)
Title
Measurements
OG0000
OG0010
OG0020
Change in PSS by greater than 3 (n= 35, 32, 46)
Title
Measurements
OG0000
OG0010
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00026
OG00131
OG00244
Title
Denominators
Categories
Baseline: R5; Treatment failure: R5
Title
Measurements
OG0008
OG0017
OG00236
Baseline: R5; Treatment failure: X4
Title
Measurements
OG0002
OG0012
OG0020
Baseline: R5; Treatment failure: DM
Title
Measurements
OG0005
OG0016
OG0023
Baseline: R5; Treatment failure: NR/NP
Title
Measurements
OG0006
OG0015
OG0022
Baseline: DM; Treatment failure: R5
Title
Measurements
OG0001
OG0010
OG0022
Baseline: DM; Treatment failure: X4
Title
Measurements
OG0000
OG0012
OG0020
Baseline: DM; Treatment failure: DM
Title
Measurements
OG0003
OG0017
OG0020
Baseline: DM; Treatment failure: NR/NP
Title
Measurements
OG0000
OG0011
OG0020
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG00041
OG00138
OG00249
Title
Denominators
Categories
Baseline: R5; Treatment failure: R5
Title
Measurements
OG00017
OG0019
OG00240
Baseline: R5; Treatment failure: X4
Title
Measurements
OG0002
OG0012
OG0020
Baseline: R5; Treatment failure: DM
Title
Measurements
OG0008
OG00110
OG0023
Baseline: R5; Treatment failure: NR/NP
Title
Measurements
OG0006
OG0016
OG0022
Baseline: DM; Treatment failure: R5
Title
Measurements
OG0001
OG0010
OG0023
Baseline: DM; Treatment failure: X4
Title
Measurements
OG0000
OG0012
OG0020
Baseline: DM; Treatment failure: DM
Title
Measurements
OG0003
OG0017
OG0020
Baseline: DM; Treatment failure: NR/NP
Title
Measurements
OG0000
OG0011
OG0020
Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
OG002
Placebo
Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Units
Counts
Participants
OG000180
OG001185
OG00291
Title
Denominators
Categories
Week 24; Screening OSS 0 (n= 22, 29, 16)
Title
Measurements
OG000-1.721± 1.0477
OG001-1.231± 1.2924
OG002-0.264± 0.8979
Week 24; Screening OSS 1 (n= 54, 48, 23)
Title
Measurements
OG000-1.822± 1.0244
OG001-2.051± 1.1860
OG002-0.651± 0.9756
Week 24; Screening OSS 2 (n= 37, 39, 21)
Title
Measurements
OG000-2.145± 1.4052
OG001-2.515± 0.8209
OG002-0.611± 0.9732
Week 24; Screening OSS >=3 (n= 64, 68, 29)
Title
Measurements
OG000-2.655± 1.1364
OG001-2.530± 1.2694
OG002-2.109± 1.3495
Week 24; Screening OSS= Missing (n= 3, 1, 2)
Title
Measurements
OG000-2.642± 0.9282
OG001-0.544± NAData was not estimable since only 1 participant was evaluable.
OG002-1.169± 2.1350
Week 48; Screening OSS 0 (n= 22, 29, 16)
Title
Measurements
OG000-1.745± 1.2354
OG001-1.290± 1.2978
OG002-0.249± 0.8727
Week 48; Screening OSS 1 (n= 54, 48, 23)
Title
Measurements
OG000-1.678± 1.2115
OG001-1.899± 1.1966
OG002-0.594± 0.9454
Week 48; Screening OSS 2 (n= 38, 39, 21)
Title
Measurements
OG000-2.207± 1.3866
OG001-2.565± 0.8734
OG002-0.591± 0.9309
Week 48; Screening OSS >=3 (n= 63, 68, 29)
Title
Measurements
OG000-2.448± 1.2477
OG001-2.426± 1.2977
OG002-1.942± 1.4167
Week 48; Screening OSS= Missing (n= 3, 1, 2)
Title
Measurements
OG000-2.795± 0.5079
OG001-0.833± NAData was not estimable since only 1 participant was evaluable.