Human Immunodeficiency Virus
Conditions
Keywords
Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics
Brief summary
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.
Interventions
DRUGMaraviroc
Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
Sponsors
Pfizer
ViiV Healthcare
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL
Exclusion criteria
* X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay * Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs) * Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; * Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST \< 2.5 X ULN; No symptoms other than jaundice or icterus. * Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) | Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean. |
| Area Under the Curve at Steady State (AUCtau) | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) | AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours. |
| Time to Reach Maximum Plasma Concentration (Tmax) | Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose) | — |
| Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Baseline up to 5 years | Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term. |
| Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug | Baseline up to 5 years | The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 24, Week 48 post-treatment | Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated. |
| Change From Baseline in HIV-1 RNA (Original) | Baseline, Week 24, Week 48 post-treatment | Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \[LLOQ\] \<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \>1000 copies/ml was used to determine eligibility for the study. |
| Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Baseline, Week 24, Week 48 post-treatment | Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \[LLOQ\] \<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \>1000 copies/ml was used to determine eligibility for the study. |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Baseline, Week 24, Week 48 post-treatment | Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics. |
| Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 24 and Week 48 post-treatment | The proportion of participants who achieved HIV-1 RNA \<400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. |
| Number of Participants With Protocol Defined Virologic Failure | Week 48 | The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA \<1 log10 and plasma HIV-1 RNA \>400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA \<2.0 log10 and plasma HIV-1 RNA \>400 copies/mL at Week 24 OR plasma HIV-1 RNA \>10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of \>=1 log10 (\>=1,000 copies/mL if nadir plasma HIV-1 RNA \<48 copies/mL) at any time, and confirmed within 14 to 21 days. |
| Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Screening to Week 48 | Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported. |
| Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | 48 weeks | Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once. |
| Percentage of Participants With Optimized Background Treatment Susceptibility Scores | 48 weeks | Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, \>=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and \>=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance. |
| Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Baseline, Week 24 and Week 48 post-treatment | Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics. |
| Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 and Week 48 post-treatment | The proportion of participants who achieved HIV-1 RNA \<48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. |
| Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 and Week 48 post-treatment | Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred to as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\]. |
| Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 24 and Week 48 post-treatment | Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\]. |
| Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | Week 48 | TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm. |
Countries
Brazil, Italy, Mexico, Portugal, Puerto Rico, South Africa, Spain, Thailand, United States
Participant flow
Recruitment details
This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study at 24 sites in 8 countries.
Pre-assignment details
The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA\>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes.
Participants by arm
| Arm | Count |
|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation In Cohort 1, Participants aged \>= 2 to \< 6 years, received MVC liquid formulation (20 mg/mL). | 16 |
| >=6 - <12 Years of Age, MVC Tablet Formulation In Cohort 2, Participants aged \>=6 to \<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | 31 |
| >=6 - <12 Years of Age, MVC Liquid Formulation In Cohort 3, Participants aged \>=6 to \<12 years, received MVC liquid formulation (20 mg/mL). | 13 |
| >=12 - <18 Years of Age, MVC Tablet Formulation In Cohort 4, Participants aged \>=12 to \<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | 43 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Insufficient clinical response | 1 | 4 | 1 | 8 |
| Overall Study | Lost to Follow-up | 4 | 3 | 4 | 6 |
| Overall Study | No longer willing to participate | 1 | 1 | 0 | 8 |
| Overall Study | Non-compliance with study treatment | 0 | 2 | 0 | 4 |
| Overall Study | Other | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawn due to pregnancy | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | >=2 - <6 Years of Age, MVC Liquid Formulation | >=6 - <12 Years of Age, MVC Tablet Formulation | >=6 - <12 Years of Age, MVC Liquid Formulation | >=12 - <18 Years of Age, MVC Tablet Formulation | Total |
|---|---|---|---|---|---|
| Age, Continuous | 3.4 Years STANDARD_DEVIATION 0.9 | 9.1 Years STANDARD_DEVIATION 1.7 | 8.9 Years STANDARD_DEVIATION 2 | 14.0 Years STANDARD_DEVIATION 1.6 | 10.3 Years STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 6 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 7 Participants | 16 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 31 | 0 / 13 | 1 / 43 |
| other Total, other adverse events | 12 / 16 | 25 / 31 | 10 / 13 | 34 / 43 |
| serious Total, serious adverse events | 5 / 16 | 5 / 31 | 3 / 13 | 10 / 43 |
Outcome results
Primary
Area Under the Curve at Steady State (AUCtau)
AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.
Time frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Population: PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed signifies participants evaluable at specified time points for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 2 | 2848.1 ng*hr/mL | Geometric Coefficient of Variation 63 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 48 | 1964.7 ng*hr/mL | Geometric Coefficient of Variation 146 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 48 | 3476.3 ng*hr/mL | Geometric Coefficient of Variation 50 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 2 | 3127.7 ng*hr/mL | Geometric Coefficient of Variation 43 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 2 | 3173.4 ng*hr/mL | Geometric Coefficient of Variation 62 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 48 | 2023.5 ng*hr/mL | Geometric Coefficient of Variation 117 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 2 | 2878.2 ng*hr/mL | Geometric Coefficient of Variation 67 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Area Under the Curve at Steady State (AUCtau) | AUCtau - Week 48 | 2389.4 ng*hr/mL | Geometric Coefficient of Variation 78 |
Primary
Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)
Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.
Time frame: Baseline up to 5 years
Population: Safety analysis was performed on all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 1 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 1 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 1 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 1 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| Cohort 3 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 1 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| Cohort 3 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 1 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 1 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 1 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
| Cohort 4 (Grade 3) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Meningitis | 1 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Gastritis | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Aggression | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations -Otitis media | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - Pneumonia | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Lipase increased | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Transaminases increased | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Pyschiatric disorder - Bipolar disorder | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Investigations - Hepatic enzyme abnormal | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Infections and infestations - H1N1 influenza | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Blood and lymphatic system disorders - Anaemia | 0 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Hepat. disorders - Drug-induced liver injury | 1 events |
| Cohort 4 (Grade 4) | Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality) | Gastrointestinal disorders - Vomiting | 0 events |
Primary
Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)
Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.
Time frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Population: PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed: participants evaluable at specified time points for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week2 | 18.97 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 202208 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week 48 | 163.73 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 146 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week 48 | 48.11 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 180 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week2 | 581.47 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 69 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week 48 | 334.68 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 156 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week2 | 237.34 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 63 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week2 | 546.80 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week2 | 260.65 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week2 | 100.02 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week 48 | 593.68 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week 48 | 82.21 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 120 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week 48 | 289.69 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week 48 | 60.03 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 245 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week 48 | 168.62 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 117 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week 48 | 284.96 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 128 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week2 | 444.37 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 61 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week2 | 264.45 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week2 | 115.84 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 90 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week 48 | 66.51 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 140 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week2 | 239.85 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 67 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cavg-Week 48 | 199.12 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 78 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week2 | 530.80 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmax-Week 48 | 423.32 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 48 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax) | Cmin-Week2 | 56.17 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 145 |
Primary
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)
Population: PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed signifies participants evaluable at specified time points for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 48 | 2.000 hour |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 2 | 2.000 hour |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 48 | 2.000 hour |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 2 | 4.000 hour |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 2 | 2.000 hour |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 48 | 3.000 hour |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 2 | 2.000 hour |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Time to Reach Maximum Plasma Concentration (Tmax) | Tmax - Week 48 | 2.000 hour |
Primary
Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug
The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.
Time frame: Baseline up to 5 years
Population: Safety analysis was performed on all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug | 0 participants |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48
Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
Time frame: Baseline, Week 24, Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 24 | 232.7 cells/mm^3 | Standard Deviation 381.6 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 48 | 275.9 cells/mm^3 | Standard Deviation 363.4 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 48 | 362.7 cells/mm^3 | Standard Deviation 373.5 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 24 | 355.8 cells/mm^3 | Standard Deviation 294 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 24 | 213.9 cells/mm^3 | Standard Deviation 166.4 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 48 | 167.3 cells/mm^3 | Standard Deviation 150.9 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 24 | 173.6 cells/mm^3 | Standard Deviation 203.6 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48 | Week 48 | 168.6 cells/mm^3 | Standard Deviation 211 |
Secondary
Change From Baseline in HIV-1 RNA (Log10 Copies/mL)
Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \[LLOQ\] \<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \>1000 copies/ml was used to determine eligibility for the study.
Time frame: Baseline, Week 24, Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 24 | -2.4853 Log10 Copies/mL | Standard Deviation 1.1421 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 48 | -2.5831 Log10 Copies/mL | Standard Deviation 1.2148 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 48 | -1.9579 Log10 Copies/mL | Standard Deviation 1.0861 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 24 | -2.2324 Log10 Copies/mL | Standard Deviation 0.8668 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 48 | -2.0549 Log10 Copies/mL | Standard Deviation 1.2125 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 24 | -2.1756 Log10 Copies/mL | Standard Deviation 1.1854 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 48 | -1.4591 Log10 Copies/mL | Standard Deviation 1.4477 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Log10 Copies/mL) | Change from Baseline - Log10 - Week 24 | -1.6482 Log10 Copies/mL | Standard Deviation 1.3806 |
Secondary
Change From Baseline in HIV-1 RNA (Original)
Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \[LLOQ\] \<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \>1000 copies/ml was used to determine eligibility for the study.
Time frame: Baseline, Week 24, Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 48 | -267834.2 copies/mL | Standard Deviation 378896.88 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 24 | -271974.6 copies/mL | Standard Deviation 391843.59 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 48 | -34787.7 copies/mL | Standard Deviation 60222.6 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 24 | -38764.0 copies/mL | Standard Deviation 63688.93 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 24 | -58081.0 copies/mL | Standard Deviation 79720.33 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 48 | -56351.7 copies/mL | Standard Deviation 76231.03 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 48 | -55321.1 copies/mL | Standard Deviation 173840.55 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in HIV-1 RNA (Original) | Change from Baseline - Original - Week 24 | -57325.7 copies/mL | Standard Deviation 172108.62 |
Secondary
Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48
Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
Time frame: Baseline, Week 24 and Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 24 | 7.3 percentage of CD4+ cells | Standard Deviation 5 |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 48 | 7.5 percentage of CD4+ cells | Standard Deviation 7.6 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 48 | 6.0 percentage of CD4+ cells | Standard Deviation 6.8 |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 24 | 3.8 percentage of CD4+ cells | Standard Deviation 7.4 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 48 | 2.5 percentage of CD4+ cells | Standard Deviation 4.2 |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 24 | 3.5 percentage of CD4+ cells | Standard Deviation 4 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 48 | 4.6 percentage of CD4+ cells | Standard Deviation 6.5 |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48 | Week 24 | 3.8 percentage of CD4+ cells | Standard Deviation 6.1 |
Secondary
Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF
Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.
Time frame: 48 weeks
Population: The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NRTI M184V | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103N | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | Total with emergence | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor V77V/I | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L89L/I/M | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L10L/F | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor K20K/R | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103K/N | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | With valid on-treatment results | 2 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103K/N | 1 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NRTI M184V | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103N | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L10L/F | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | With valid on-treatment results | 4 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L89L/I/M | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | Total with emergence | 1 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor K20K/R | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor V77V/I | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103K/N | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | With valid on-treatment results | 3 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L10L/F | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L89L/I/M | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor V77V/I | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103N | 1 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NRTI M184V | 1 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor K20K/R | 2 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | Total with emergence | 3 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NRTI M184V | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor V77V/I | 1 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L89L/I/M | 1 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | Total with emergence | 4 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor K20K/R | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | PI Minor L10L/F | 1 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103N | 1 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | NNRTI K103K/N | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF | With valid on-treatment results | 11 participants |
Secondary
Number of Participants With Protocol Defined Virologic Failure
The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA \<1 log10 and plasma HIV-1 RNA \>400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA \<2.0 log10 and plasma HIV-1 RNA \>400 copies/mL at Week 24 OR plasma HIV-1 RNA \>10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of \>=1 log10 (\>=1,000 copies/mL if nadir plasma HIV-1 RNA \<48 copies/mL) at any time, and confirmed within 14 to 21 days.
Time frame: Week 48
Population: The FAS consisted of all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria B | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria C | 3 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria A | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria A | 2 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria C | 3 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria B | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria B | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria A | 1 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria C | 2 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria A | 5 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria C | 8 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Protocol Defined Virologic Failure | Criteria B | 0 participants |
Secondary
Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48
Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.
Time frame: Screening to Week 48
Population: Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF X4 | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | With valid on-treatment results | 2 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF Not Reportable | 1 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF DM | 0 participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF R5 | 2 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF DM | 1 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF X4 | 0 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | With valid on-treatment results | 4 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF R5 | 3 participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF Not Reportable | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF DM | 1 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | With valid on-treatment results | 3 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF R5 | 2 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF X4 | 0 participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF Not Reportable | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF X4 | 0 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF R5 | 9 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | With valid on-treatment results | 11 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF DM | 2 participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48 | Tropism at Confirmed PDVF Not Reportable | 1 participants |
Secondary
Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48
Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.
Time frame: Baseline to Week 24, Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. Last Observation Carried Forward (LOCF) was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 24 | 92.3 percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 48 | 100.0 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 48 | 96.2 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 24 | 100.0 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 24 | 100.0 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 48 | 100.0 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 24 | 93.1 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48 | Baseline to Week 48 | 88.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48
TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.
Time frame: Week 48
Population: The FAS consisted of all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <48 copies/mL; TLOVR Responder | 43.8 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <400 copies/mL; TLOVR Responder | 62.5 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <48 copies/mL; TLOVR Responder | 54.8 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <400 copies/mL; TLOVR Responder | 74.2 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <400 copies/mL; TLOVR Responder | 69.2 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <48 copies/mL; TLOVR Responder | 46.2 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <48 copies/mL; TLOVR Responder | 44.2 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48 | <400 copies/mL; TLOVR Responder | 48.8 Percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach
The proportion of participants who achieved HIV-1 RNA \<400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
Time frame: Week 24 and Week 48 post-treatment
Population: The FAS consisted of all participants who receive at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 24 | 68.8 percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 48 | 75.0 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 48 | 77.4 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 24 | 90.3 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 24 | 69.2 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 48 | 69.2 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 24 | 62.8 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach | Week 48 | 51.2 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach
The proportion of participants who achieved HIV-1 RNA \<48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
Time frame: Week 24 and Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 18.75 percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 50.0 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 54.8 percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 64.5 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 61.5 percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 53.8 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 48.8 percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 39.5 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach
Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred to as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\].
Time frame: Week 24 and Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies the number of participants evaluable for this measure.Number analyzed signifies participants evaluable at specified time points for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 62.5 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 75.0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 74.2 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 87.10 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 69.2 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 69.2 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 24 | 62.8 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach | Week 48 | 51.2 Percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach
Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \> lower limit of quantification (LLOQ) . This referred as \[non-completer = failure; NC=F\] or \[missing, discontinuation = failure; MD=F\].
Time frame: Week 24 and Week 48 post-treatment
Population: The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies the number of participants evaluable for this measure.Number analyzed signifies participants evaluable at specified time points for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 24 | 18.8 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 48 | 50.0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 48 | 54.8 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 24 | 64.5 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 24 | 61.5 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 48 | 53.8 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 24 | 48.8 Percentage of participants |
| >=12 - <18 Years of Age, MVC Tablet Formulation | Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach | Week 48 | 39.5 Percentage of participants |
Secondary
Percentage of Participants With Optimized Background Treatment Susceptibility Scores
Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, \>=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and \>=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.
Time frame: 48 weeks
Population: The FAS consisted of all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score >=2.0 | 28.6 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score >=2.0 | 81.6 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 0 | 0 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 0-0.5 | 6.1 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 1.0 | 8.2 Percentage of participants |
| >=2 - <6 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 1.0-1.5 | 53.1 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 0 | 0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 1.0-1.5 | 65.2 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score >=2.0 | 95.7 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score >=2.0 | 4.3 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 1.0 | 4.3 Percentage of participants |
| >=6 - <12 Years of Age, MVC Tablet Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 0-0.5 | 30.4 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score >=2.0 | 38.7 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 0 | 0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score >=2.0 | 96.8 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 0-0.5 | 29.0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Weighted score 1.0-1.5 | 29.0 Percentage of participants |
| >=6 - <12 Years of Age, MVC Liquid Formulation | Percentage of Participants With Optimized Background Treatment Susceptibility Scores | Simple score 1.0 | 0 Percentage of participants |