HIV Infections
Conditions
Brief summary
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
Detailed description
This study examined the pharmacokinetics (PK), safety, and tolerability of fixed-dose combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate release tablets in children living with HIV less than 12 years of age. Children were enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The first 5-7 children within each weight-band underwent intensive PK assessments 5-10 days after starting ABC/DTG/3TC to confirm dose selection. Children remained on their initial dose of ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing was adjusted based on PK results at the individual or weight-band level, and/or an individual child's growth and weight gain over time. Follow-up study visits for all participants occurred at Weeks 1, 4, 12, 24, 36, and 48. If participants had a known M184 resistance mutation, they had additional study visits at Weeks 8, 16, and 20. Study visits included physical examination, study drug adherence and tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week 48 study visit, some children were allowed to continue follow-up through up to 144 weeks if alternative post-study drug supply was not yet available.
Interventions
DRUGAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
DRUGAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food
Sponsors
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
ViiV Healthcare
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Years
Healthy volunteers
No
Inclusion criteria
* Weight 6 kg to less than 40 kg at entry * Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry * Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior to diagnosis of HIV infection is permitted. For these children, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion. * Note: For ART-experienced children (on a stable ART regimen), dose and formulation changes (e.g., for growth) within the six months prior to entry are permitted. For these children, ascertainment of this criterion must be based on medical records. * For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral load (HIV-1 RNA less than 200 copies/mL) for at least six consecutive months prior to entry * Note: To fulfill this criterion, at least two documented HIV-1 RNA results less than 200 copies/mL must be available, one based on a specimen collected at least six months prior to entry and one based on a specimen collected within 30 days prior to entry. * Note: Any documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry is exclusionary (see exclusion criterion below). * At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the following, based on testing of specimens collected within 30 days prior to entry and grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (refer to the study protocol for guidance on severity grading): * Hemoglobin (greater than or equal to 8.5 g/dL or greater than or equal to 5.25 mmol/L) * Absolute neutrophil count (greater than or equal to 600 cells/mm\^3 or greater than or equal to 0.600 x 10\^9 cells/L) * Platelet count (greater than or equal to 50,000 cells/mm\^3 or greater than or equal to 50.00 x 10\^9 cells/L) * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater than or equal to 60 ml/min/1.73 m\^2) * Alanine transaminase (ALT) (less than 5.0 x ULN) * Aspartate aminotransferase (AST) (less than 5.0 x ULN) * Total bilirubin (less than 2.6 x ULN) * Direct bilirubin (less than or equal to ULN) * Note: Laboratory tests may be repeated during the screening period (i.e., within 30 days prior to entry), with the latest results used for eligibility determination. * Note: For treatment-experienced children on an atazanavir-containing ART regimen, Grade 3 or higher total bilirubin is permitted. * At screening, has a negative test result for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry * Confirmed HIV-1-infection based on documented testing of two samples collected at different time points: * Sample #1 may be tested using any of the following: * Two rapid antibody tests from different manufacturers or based on different principles and epitopes * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay * One HIV DNA polymerase chain reaction (PCR)\* * One quantitative HIV RNA PCR (above the limit of detection of the assay)\* * One qualitative HIV RNA PCR\* * One HIV total nucleic acid test\* * Sample #2 may be tested using any of the following: * Rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be United States Food and Drug Administration (FDA)-approved, and the third rapid test must be from a third manufacturer or based on a third principle or epitope. * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay * One HIV DNA PCR\* * One quantitative HIV RNA PCR (above the limit of detection of the assay)\* * One qualitative HIV RNA PCR\* * One HIV total nucleic acid test\* * For participants who are less than two years of age, or who are two years of age and older with any exposure to breast milk in the past 28 days, HIV-1 infection must be confirmed using the tests indicated above with an asterisk (\*) for Sample #1 and Sample #2. * Whole blood, plasma, or serum samples must be tested. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to Good Clinical Laboratory Practice guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified (for US sites) or Virology Quality Assurance (VQA) certified (for non-US sites) laboratory. For tests performed in other settings, adequate source documentation including the date of specimen collection, date of testing, test performed, and test result must be available. FDA approved testing methods should be used when possible. * HLA-B\*5701-negative based on documented testing at any time prior to entry * Note: Documented testing is required even if the potential participant has received ABC prior to study entry. * For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening * For females of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug, based on participant and parent or guardian report at entry * One of the two methods must be highly effective; highly effective methods include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) and the following: * Contraceptive intrauterine device or intrauterine system * Subdermal contraceptive implant * Progestogen injections * Combined estrogen and progestogen oral contraceptive pills * Percutaneous contraceptive patch * Contraceptive vaginal ring * The highly effective method must be initiated prior to study entry. The second method should ideally be a barrier method. Male or female condom use is recommended with all other methods of contraception for dual protection against pregnancy and to avoid transmission of HIV and other sexually transmitted infections. * Based on parent or guardian report at entry, child is expected to be available for 48 weeks of follow-up * Parent or legal guardian is willing and able to provide written informed consent for child's study participation and, when applicable per local institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written informed assent for study participation
Exclusion criteria
* Documented resistance to ABC, DTG, or 3TC * Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary. * For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry * History of any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records: * Malignancy (ever) * Hypersensitivity reaction to ABC (ever) * Receipt of any prohibited medication (refer to the study protocol for more information) within 30 days prior to study entry * Receipt of systemic interferon or any chronic systemic immunosuppressant medication within 30 days prior to study entry * Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg) taken for replacement or short course therapy are permitted. Intranasal or inhaled steroid use is also permitted. * Has any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records * Current clinical evidence of pancreatitis * Currently-active tuberculosis (TB) and/or currently receiving rifampicin-containing TB treatment * Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection * Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug\*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. |
| Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. |
| Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. |
| Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | Measured from treatment initiation through Week 24 | Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported. |
| Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | Measured from treatment initiation through Week 24 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | Measured from treatment initiation through Week 24 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | Measured from treatment initiation through Week 24 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual). |
| Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | Measured from treatment initiation through Week 24 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual. |
| Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | Measured from treatment initiation through Week 24 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual. |
| Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual. |
| Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. |
| Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual. |
| Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual. |
| Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | Measured from treatment initiation through Week 60 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
| Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Measured from treatment initiation through Week 48 | Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. |
| Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Measured from treatment initiation through Week 60 | Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. |
| Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Weeks 4, 24, and 48 | Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. |
| Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Weeks 4, 24, and 48 | Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. |
| Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Weeks 4, 24, and 48 | Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. |
| Median (Q1, Q3) CD4+ Cell Count | Weeks 4, 24, and 48 | Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. |
| Median (Q1, Q3) CD4+ Percentage | Weeks 4, 24, and 48 | Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. |
| Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline, Weeks 24 and 48 | Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. |
| Median (Q1,Q3) Change From Baseline in HDL | Baseline, Weeks 24 and 48 | Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. |
| Median (Q1,Q3) Change From Baseline in LDL | Baseline, Weeks 24 and 48 | Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. |
| Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline, Weeks 24 and 48 | Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. |
| Parent/Guardian-reported Percent Adherence to Study Drug | Weeks 4, 24, and 48 | Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses. |
| Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Parent/Guardian-reported Reason for Missed Doses of Study Drug | Weeks 4, 24, and 48 | Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. |
| Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Weeks 4, 24, and 48 | Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. |
| Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Weeks 4, 24, and 48 | Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. |
| Parent/Guardian-reported Ease of Giving Study Drug | Weeks 4, 12, 24, and 48 | Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses. |
| Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Weeks 4, 12, 24, and 48 | Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses. |
| Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Weeks 4, 12, 24, and 48 | Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses. |
| Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Weeks 4, 12, 24, and 48 | Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses |
| Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Weeks 4, 12, 24, and 48 | Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses |
| Antiretroviral (ARV) Resistance Mutations | Entry and confirmation of virologic failure | ARV resistance mutations at time of virologic failure and at entry for children with virologic failure. |
| Parent/Guardian-reported Number of Missed Doses of Study Drug | Weeks 4, 24, and 48 | Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. |
| Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | Measured from Week 1 through Week 48 over 24 hours post-dose | Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. |
| Percentage of Participants With at Least One Adverse Event Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. |
| Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | Measured from treatment initiation through Week 48 | AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. |
Countries
Botswana, South Africa, Thailand, United States
Participant flow
Recruitment details
Accrual occurred between September 2020 and June 2021 in Botswana, South Africa, Thailand, and the United States at 14 different medical clinic sites.
Participants by arm
| Arm | Count |
|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food | 9 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food | 12 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food | 15 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food | 10 |
| Weight Band #5 (25 kg or Greater at Study Entry) Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food | 11 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Main Study (Through Week 48) | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Weight Band #5 (25 kg or Greater at Study Entry) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 1.35 years | 3.56 years | 6.44 years | 8.41 years | 9.74 years | 6.38 years |
| Age, Customized 6 to <12 years | 0 Participants | 0 Participants | 8 Participants | 10 Participants | 11 Participants | 29 Participants |
| Age, Customized <6 years | 9 Participants | 12 Participants | 7 Participants | 0 Participants | 0 Participants | 28 Participants |
| CD4+ Cell Count | 2321 cells/mm^3 | 1452 cells/mm^3 | 886 cells/mm^3 | 1155 cells/mm^3 | 915 cells/mm^3 | 1201 cells/mm^3 |
| CD4+ Percentage | 34.0 percentage of CD4+ in total lymphocytes | 33.9 percentage of CD4+ in total lymphocytes | 32.9 percentage of CD4+ in total lymphocytes | 32.6 percentage of CD4+ in total lymphocytes | 37.7 percentage of CD4+ in total lymphocytes | 35.1 percentage of CD4+ in total lymphocytes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 12 Participants | 15 Participants | 10 Participants | 7 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| High-Density Lipoprotein (HDL) Cholesterol | 0.98 mmol/L | 1.53 mmol/L | 1.38 mmol/L | 1.67 mmol/L | 1.34 mmol/L | 1.37 mmol/L |
| HIV-1 RNA <200 copies/mL | 5 Participants | 12 Participants | 15 Participants | 10 Participants | 11 Participants | 53 Participants |
| HIV-1 RNA ≥200 copies/mL | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Known M184V mutation No | 9 Participants | 12 Participants | 13 Participants | 10 Participants | 9 Participants | 53 Participants |
| Known M184V mutation Yes | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Low-Density Lipoprotein (LDL) Cholesterol | 2.52 mmol/L | 2.25 mmol/L | 2.50 mmol/L | 3.04 mmol/L | 2.36 mmol/L | 2.52 mmol/L |
| Pre-study Antiretroviral (ART) experience ART-experienced | 6 Participants | 12 Participants | 15 Participants | 10 Participants | 11 Participants | 54 Participants |
| Pre-study Antiretroviral (ART) experience ART-naive | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 7 Participants | 4 Participants | 3 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 7 Participants | 6 Participants | 8 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Botswana | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 13 Participants |
| Region of Enrollment South Africa | 2 Participants | 7 Participants | 4 Participants | 3 Participants | 1 Participants | 17 Participants |
| Region of Enrollment Thailand | 3 Participants | 1 Participants | 6 Participants | 4 Participants | 3 Participants | 17 Participants |
| Region of Enrollment United States | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 5 Participants | 3 Participants | 6 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 10 Participants | 7 Participants | 5 Participants | 31 Participants |
| Total Cholesterol | 4.01 mmol/L | 4.61 mmol/L | 4.51 mmol/L | 5.19 mmol/L | 4.27 mmol/L | 4.51 mmol/L |
| Triglycerides | 1.71 mmol/L | 1.20 mmol/L | 1.23 mmol/L | 1.08 mmol/L | 1.76 mmol/L | 1.20 mmol/L |
| Weight | 9.2 kilograms | 12.9 kilograms | 17.0 kilograms | 21.5 kilograms | 28.5 kilograms | 17.0 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 | 0 / 15 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 8 / 9 | 10 / 12 | 15 / 15 | 10 / 10 | 10 / 11 |
| serious Total, serious adverse events | 1 / 9 | 1 / 12 | 0 / 15 | 1 / 10 | 0 / 11 |
Outcome results
Primary
Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC
Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug\*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
Time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Population: Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Abacavir (ABC) | 17.7 h*ug/mL | Geometric Coefficient of Variation 33.8 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Lamivudine (3TC) | 10.7 h*ug/mL | Geometric Coefficient of Variation 46 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Dolutegravir (DTG) | 75.9 h*ug/mL | Geometric Coefficient of Variation 33.7 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Dolutegravir (DTG) | 91.0 h*ug/mL | Geometric Coefficient of Variation 36.5 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Abacavir (ABC) | 19.8 h*ug/mL | Geometric Coefficient of Variation 50.6 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Lamivudine (3TC) | 14.2 h*ug/mL | Geometric Coefficient of Variation 23.9 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Dolutegravir (DTG) | 71.4 h*ug/mL | Geometric Coefficient of Variation 23.5 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Abacavir (ABC) | 15.1 h*ug/mL | Geometric Coefficient of Variation 40.3 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Lamivudine (3TC) | 13.0 h*ug/mL | Geometric Coefficient of Variation 15.6 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Abacavir (ABC) | 17.4 h*ug/mL | Geometric Coefficient of Variation 19.4 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Lamivudine (3TC) | 14.5 h*ug/mL | Geometric Coefficient of Variation 16.6 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Dolutegravir (DTG) | 84.4 h*ug/mL | Geometric Coefficient of Variation 26.3 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Dolutegravir (DTG) | 71.8 h*ug/mL | Geometric Coefficient of Variation 13.9 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Abacavir (ABC) | 25.7 h*ug/mL | Geometric Coefficient of Variation 14.6 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC | Lamivudine (3TC) | 21.7 h*ug/mL | Geometric Coefficient of Variation 26.2 |
Primary
Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
Time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Population: Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.003 ug/mL | Geometric Coefficient of Variation 127.6 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.055 ug/mL | Geometric Coefficient of Variation 39.5 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 0.91 ug/mL | Geometric Coefficient of Variation 67.6 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.22 ug/mL | Geometric Coefficient of Variation 77.5 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.005 ug/mL | Geometric Coefficient of Variation 127.4 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.046 ug/mL | Geometric Coefficient of Variation 48.3 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 0.79 ug/mL | Geometric Coefficient of Variation 44.2 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.003 ug/mL | Geometric Coefficient of Variation 107.5 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.058 ug/mL | Geometric Coefficient of Variation 36.7 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.004 ug/mL | Geometric Coefficient of Variation 84.9 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.060 ug/mL | Geometric Coefficient of Variation 18.3 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.35 ug/mL | Geometric Coefficient of Variation 95.5 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 0.98 ug/mL | Geometric Coefficient of Variation 27.9 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.011 ug/mL | Geometric Coefficient of Variation 228.5 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.084 ug/mL | Geometric Coefficient of Variation 35 |
Primary
Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
Time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Population: Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 7.30 ug/mL | Geometric Coefficient of Variation 20.5 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.29 ug/mL | Geometric Coefficient of Variation 39.8 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 7.40 ug/mL | Geometric Coefficient of Variation 28 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 8.85 ug/mL | Geometric Coefficient of Variation 21.3 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 8.36 ug/mL | Geometric Coefficient of Variation 43.7 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 3.55 ug/mL | Geometric Coefficient of Variation 18.7 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 7.04 ug/mL | Geometric Coefficient of Variation 17 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 6.26 ug/mL | Geometric Coefficient of Variation 31 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.92 ug/mL | Geometric Coefficient of Variation 23 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 6.65 ug/mL | Geometric Coefficient of Variation 27.7 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.99 ug/mL | Geometric Coefficient of Variation 31.9 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 7.29 ug/mL | Geometric Coefficient of Variation 16.7 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 6.25 ug/mL | Geometric Coefficient of Variation 20.6 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 9.04 ug/mL | Geometric Coefficient of Variation 21.9 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 4.15 ug/mL | Geometric Coefficient of Variation 29.3 |
Primary
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Had at Least One Adverse Event Through Week 24
Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | 90.9 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | 80.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 24 | 80.0 percentage of participants |
Primary
Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
Time frame: Measured from treatment initiation through Week 24
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24 | 0.0 percentage of participants |
Secondary
Antiretroviral (ARV) Resistance Mutations
ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.
Time frame: Entry and confirmation of virologic failure
Population: Participants experiencing confirmed virologic failure. Due to assay limitations, mutation results could not be obtained from the specimen collected at the virologic failure confirmation visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase V245E | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase A272P | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase R277K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase T286A | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase L295L/I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase E312N | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase I326V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase I329V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase G335D | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase M357K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K358R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase G359S | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K366R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase A371V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase T377S | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K390R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K395R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase A400T | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase K14R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase A21T | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V31I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V72I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase L74I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase T112V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V113I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase T125A | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V126L | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase G134N | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase I135V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase K136R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V165I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase A196P | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V236I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase V281M | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Integrase S283G | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease L10V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease I13V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease G16E | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease E35D | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease M36I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease R41K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease K43R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease H69K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease I72V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Protease L89M | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase E6D | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K11T | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K20R | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase V35T | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase T39K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K43E | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase Q102K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K122E | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase D123S | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase C162S | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase T165I | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase K173A | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase Q174K | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase D177E | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase T200A | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase I202V | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase Q207A | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase L210M | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Antiretroviral (ARV) Resistance Mutations | Entry Visit: Reverse Transcriptase R211S | 1 Participants |
Secondary
Median (Q1, Q3) CD4+ Cell Count
Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 24 | 2208 cells/mm^3 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 4 | 3528 cells/mm^3 |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 48 | 1853 cells/mm^3 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 4 | 1385 cells/mm^3 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 48 | 1235 cells/mm^3 |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 24 | 1184 cells/mm^3 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 4 | 812 cells/mm^3 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 24 | 894 cells/mm^3 |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 48 | 930 cells/mm^3 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 48 | 942 cells/mm^3 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 4 | 992 cells/mm^3 |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 24 | 944 cells/mm^3 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 24 | 920 cells/mm^3 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 4 | 841 cells/mm^3 |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Cell Count | Week 48 | 777 cells/mm^3 |
Secondary
Median (Q1, Q3) CD4+ Percentage
Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 4 | 41.6 percentage of CD4+ in total lymphocytes |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 48 | 34.8 percentage of CD4+ in total lymphocytes |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 24 | 36.6 percentage of CD4+ in total lymphocytes |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 24 | 35.2 percentage of CD4+ in total lymphocytes |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 4 | 33.9 percentage of CD4+ in total lymphocytes |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 48 | 34.1 percentage of CD4+ in total lymphocytes |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 24 | 33.5 percentage of CD4+ in total lymphocytes |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 4 | 32.4 percentage of CD4+ in total lymphocytes |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 48 | 30.5 percentage of CD4+ in total lymphocytes |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 4 | 34.4 percentage of CD4+ in total lymphocytes |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 48 | 33.5 percentage of CD4+ in total lymphocytes |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 24 | 37.7 percentage of CD4+ in total lymphocytes |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 24 | 38.6 percentage of CD4+ in total lymphocytes |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 4 | 39.5 percentage of CD4+ in total lymphocytes |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1, Q3) CD4+ Percentage | Week 48 | 37.6 percentage of CD4+ in total lymphocytes |
Secondary
Median (Q1,Q3) Change From Baseline in HDL
Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
Time frame: Baseline, Weeks 24 and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 24 | -0.01 mmol/L |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 48 | -0.10 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 24 | -0.06 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 48 | -0.20 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 24 | -0.19 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 48 | -0.24 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 48 | -0.19 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 24 | -0.15 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 24 | -0.06 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in HDL | Baseline to Week 48 | 0.05 mmol/L |
Secondary
Median (Q1,Q3) Change From Baseline in LDL
Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
Time frame: Baseline, Weeks 24 and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 24 | 0.18 mmol/L |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 48 | 0.05 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 24 | -0.20 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 48 | -0.13 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 24 | -0.26 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 48 | -0.30 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 48 | 0.00 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 24 | -0.22 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 24 | -0.21 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in LDL | Baseline to Week 48 | 0.03 mmol/L |
Secondary
Median (Q1,Q3) Change From Baseline in Total Cholesterol
Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
Time frame: Baseline, Weeks 24 and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 24 | -0.31 mmol/L |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 48 | 0.00 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 24 | -0.70 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 48 | -0.50 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 24 | -0.67 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 48 | -0.68 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 48 | -0.25 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 24 | -0.32 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 24 | -0.18 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in Total Cholesterol | Baseline to Week 48 | -0.09 mmol/L |
Secondary
Median (Q1,Q3) Change From Baseline in Triglycerides
Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
Time frame: Baseline, Weeks 24 and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 24 | -0.51 mmol/L |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 48 | -0.43 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 24 | -0.51 mmol/L |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 48 | -0.32 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 24 | -0.17 mmol/L |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 48 | -0.21 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 48 | 0.00 mmol/L |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 24 | -0.20 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 24 | -0.24 mmol/L |
| Weight Band #5 (25 kg or Greater at Study Entry) | Median (Q1,Q3) Change From Baseline in Triglycerides | Baseline to Week 48 | -0.27 mmol/L |
Secondary
Parent/Guardian-reported Ease of Giving Study Drug
Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.
Time frame: Weeks 4, 12, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes by themselves easily | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes easily with help | 6 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | You need to hold and force the child | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes by themselves easily | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes easily with help | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | You need to hold and force the child | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes by themselves easily | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes easily with help | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | You need to hold and force the child | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes by themselves easily | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes easily with help | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | You need to hold and force the child | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes easily with help | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes easily with help | 6 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes by themselves easily | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | You need to hold and force the child | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes by themselves easily | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | You need to hold and force the child | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes easily with help | 8 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes by themselves easily | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes by themselves easily | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes easily with help | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | You need to hold and force the child | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | You need to hold and force the child | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes with help but you need to threaten, bribe, or promise a reward | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes easily with help | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | You need to hold and force the child | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes by themselves easily | 10 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes easily with help | 5 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | You need to hold and force the child | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes by themselves easily | 12 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes easily with help | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | You need to hold and force the child | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes by themselves easily | 10 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes by themselves easily | 11 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | You need to hold and force the child | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes easily with help | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes easily with help | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | You need to hold and force the child | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes easily with help | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | You need to hold and force the child | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes easily with help | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes by themselves easily | 6 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | You need to hold and force the child | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes by themselves easily | 9 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | You need to hold and force the child | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes by themselves easily | 7 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes by themselves easily | 8 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes with help but you need to threaten, bribe, or promise a reward | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes easily with help | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes by themselves easily | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes easily with help | 3 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes by themselves easily | 9 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes easily with help | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | You need to hold and force the child | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | You need to hold and force the child | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes easily with help | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | The child takes by themselves easily | 8 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes by themselves easily | 9 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 24 | You need to hold and force the child | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 12 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 48 | The child takes easily with help | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | You need to hold and force the child | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Ease of Giving Study Drug | Week 4 | The child takes with help but you need to threaten, bribe, or promise a reward | 0 Participants |
Secondary
Parent/Guardian-reported Number of Missed Doses of Study Drug
Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 4 | 0 missed doses |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 48 | 0 missed doses |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 24 | 0 missed doses |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 24 | 0 missed doses |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 4 | 0 missed doses |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 48 | 0 missed doses |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 24 | 0 missed doses |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 4 | 0 missed doses |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 48 | 0 missed doses |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 4 | 0 missed doses |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 48 | 0 missed doses |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 24 | 0 missed doses |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 24 | 0 missed doses |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 4 | 0 missed doses |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Number of Missed Doses of Study Drug | Week 48 | 0 missed doses |
Secondary
Parent/Guardian-reported Percent Adherence to Study Drug
Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 4 | 100.0 percentage of study drug taken |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 48 | 100.0 percentage of study drug taken |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 24 | 100.0 percentage of study drug taken |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 24 | 100.0 percentage of study drug taken |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 4 | 100.0 percentage of study drug taken |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 48 | 100.0 percentage of study drug taken |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 24 | 100.0 percentage of study drug taken |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 4 | 100.0 percentage of study drug taken |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 48 | 100.0 percentage of study drug taken |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 4 | 100.0 percentage of study drug taken |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 48 | 100.0 percentage of study drug taken |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 24 | 100.0 percentage of study drug taken |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 24 | 100.0 percentage of study drug taken |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 4 | 100.0 percentage of study drug taken |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Percent Adherence to Study Drug | Week 48 | 100.0 percentage of study drug taken |
Secondary
Parent/Guardian-reported Reason for Missed Doses of Study Drug
Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48. All other instances of missing data were due to participants with no missed doses not responding to this question specifying the reason.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver too sick | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Change in daily routine | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Forgot to administer medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | No missed doses | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver too sick | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Change in daily routine | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Forgot to administer medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | No missed doses | 7 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Both parents were admitted in the hospital | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver too sick | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver was too busy to give the medication | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Change in daily routine | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Forgot to administer medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | No missed doses | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Forgot to administer medication | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver too sick | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Change in daily routine | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Change in daily routine | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Forgot to administer medication | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Forgot to administer medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver too sick | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Change in daily routine | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | No missed doses | 8 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver too sick | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | No missed doses | 9 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | No missed doses | 10 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Change in daily routine | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | No missed doses | 14 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | No missed doses | 13 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Change in daily routine | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver too sick | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Forgot to administer medication | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | No missed doses | 14 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver too sick | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Forgot to administer medication | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Change in daily routine | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver too sick | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Forgot to administer medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Forgot to administer medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Forgot to administer medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | No missed doses | 10 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver too sick | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Change in daily routine | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Forgot to administer medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | No missed doses | 9 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Tried to spit it out because of taste (away from caregiver) | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | No missed doses | 9 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver too sick | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver too sick | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Change in daily routine | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Change in daily routine | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | No missed doses | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Change in daily routine | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Mom was in a hurry and forgot to give child medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Forgot to administer medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Change in daily routine | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | No missed doses | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver too sick | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Caregiver too sick | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Mom was in a hurry and forgot to give child medication | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Change in daily routine | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 24 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Forgot to administer medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Tried to spit it out because of taste (away from caregiver) | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver too sick | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Both parents were admitted in the hospital | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 4 | Forgot to administer medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | Caregiver was too busy to give the medication | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Reason for Missed Doses of Study Drug | Week 48 | No missed doses | 10 Participants |
Secondary
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food
Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.
Time frame: Weeks 4, 12, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Average | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Average | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very good | 6 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very good | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Average | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Good | 4 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Good | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very good | 4 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very good | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Average | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Good | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very good | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Good | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very good | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very good | 6 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very good | 6 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Average | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Average | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Average | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Average | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Average | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Good | 9 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Average | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very good | 7 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Average | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very bad | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very good | 8 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Good | 5 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Average | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very good | 9 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Good | 6 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Average | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Average | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very good | 6 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very good | 4 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very good | 7 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Good | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Average | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Average | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very good | 6 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Average | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Average | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Good | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Very good | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very good | 8 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Average | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 12 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 4 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 24 | Very good | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Average | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Favorite Food | Week 48 | Very good | 11 Participants |
Secondary
Parent/Guardian-reported Response of Child's Face When Taking Study Drug
Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.
Time frame: Weeks 4, 12, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Average | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Average | 4 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Good | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very good | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Bad | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Average | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very bad | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Good | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very good | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very good | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Good | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very bad | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Average | 4 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Bad | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very good | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very bad | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very good | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very good | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Average | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very bad | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Good | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Average | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Average | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very bad | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Average | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Average | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very good | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Good | 10 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Average | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Bad | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very bad | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Good | 5 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Average | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Bad | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very bad | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very good | 5 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Average | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Bad | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very bad | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very good | 5 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Good | 6 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Bad | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very bad | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Average | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Average | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Bad | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very bad | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very good | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Bad | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Average | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Average | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Good | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very bad | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Average | 3 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Average | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Good | 4 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Very good | 6 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very good | 5 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Average | 4 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 12 | Bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 4 | Very bad | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 24 | Very good | 6 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Average | 5 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of Child's Face When Taking Study Drug | Week 48 | Very good | 6 Participants |
Secondary
Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to
Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Never | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Sometimes | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Usually | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Always | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Sometimes | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Usually | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Usually | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Sometimes | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Never | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Almost always | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Never | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Almost always | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Always | 6 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Always | 7 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Almost always | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Always | 9 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Almost always | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Always | 9 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Sometimes | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Sometimes | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Always | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Usually | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Almost always | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Sometimes | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Almost always | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Never | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Usually | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Never | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Usually | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Never | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Usually | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Always | 14 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Almost always | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Usually | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Sometimes | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Never | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Always | 12 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Almost always | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Sometimes | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Never | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Always | 13 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Almost always | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Usually | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Sometimes | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Never | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Always | 9 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Usually | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Never | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Usually | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Never | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Sometimes | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Almost always | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Never | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Usually | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Always | 10 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Almost always | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Almost always | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Sometimes | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Sometimes | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Always | 6 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Sometimes | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Sometimes | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Never | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Never | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Always | 10 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Always | 11 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Sometimes | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Almost always | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Usually | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Never | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 48 | Usually | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 4 | Almost always | 1 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Usually | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Almost always | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to | Week 24 | Always | 9 Participants |
Secondary
Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to
Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Poor | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Fair | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Excellent | 4 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Fair | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Good | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Good | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Fair | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Poor | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Very good | 5 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Poor | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Very good | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Excellent | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Excellent | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Very good | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Excellent | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Very good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Excellent | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Fair | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Fair | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Excellent | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Good | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Very good | 3 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Fair | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Very good | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Poor | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Good | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Poor | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Good | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Poor | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Good | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Excellent | 12 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Very good | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Good | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Fair | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Poor | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Excellent | 10 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Very good | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Fair | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Poor | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Excellent | 12 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Very good | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Good | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Fair | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Poor | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Excellent | 7 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Good | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Poor | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Good | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Poor | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Fair | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Very good | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Poor | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Good | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Excellent | 7 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Very good | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Very good | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Fair | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Fair | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Excellent | 5 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Fair | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Fair | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Poor | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Poor | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Excellent | 9 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Excellent | 11 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Fair | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Very good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Poor | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 48 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 4 | Very good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Good | 0 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Very good | 2 Participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to | Week 24 | Excellent | 9 Participants |
Secondary
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve
Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses
Time frame: Weeks 4, 12, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is acceptable | 7 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too few | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too many | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is acceptable | 7 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too few | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too few | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is acceptable | 8 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too many | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too many | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too many | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too few | 0 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is acceptable | 8 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too many | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is acceptable | 10 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is acceptable | 11 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too few | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is acceptable | 11 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too many | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is acceptable | 10 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too few | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too many | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too few | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too few | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too many | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too many | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is acceptable | 15 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too many | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too few | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is acceptable | 15 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too many | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too few | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is acceptable | 14 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too few | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is acceptable | 15 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too many | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too few | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too few | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is too many | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is acceptable | 8 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is acceptable | 4 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 12 | It is acceptable | 9 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too few | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too few | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 48 | It is too many | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too many | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is acceptable | 10 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 4 | It is too many | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve | Week 24 | It is too few | 0 Participants |
Secondary
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve
Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses
Time frame: Weeks 4, 12, 24, and 48
Population: All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | Less than 1 minute | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 3 to 5 minutes | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 1 to less than 3 minutes | 5 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | Less than 1 minute | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 3 to 5 minutes | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 3 to 5 minutes | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | Less than 1 minute | 2 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 1 to less than 3 minutes | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 1 to less than 3 minutes | 3 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 1 to less than 3 minutes | 5 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 3 to 5 minutes | 1 Participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | Less than 1 minute | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 1 to less than 3 minutes | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | Less than 1 minute | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | Less than 1 minute | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 3 to 5 minutes | 0 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | Less than 1 minute | 4 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 1 to less than 3 minutes | 6 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | Less than 1 minute | 5 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 3 to 5 minutes | 2 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 1 to less than 3 minutes | 7 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 3 to 5 minutes | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 3 to 5 minutes | 1 Participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 1 to less than 3 minutes | 6 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 1 to less than 3 minutes | 10 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | Less than 1 minute | 0 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 1 to less than 3 minutes | 11 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 3 to 5 minutes | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | Less than 1 minute | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 1 to less than 3 minutes | 8 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 3 to 5 minutes | 3 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | Less than 1 minute | 4 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 3 to 5 minutes | 1 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | Less than 1 minute | 2 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 1 to less than 3 minutes | 11 Participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 3 to 5 minutes | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 3 to 5 minutes | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | 1 to less than 3 minutes | 6 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | Less than 1 minute | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | Less than 1 minute | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 12 | Less than 1 minute | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 3 to 5 minutes | 1 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 3 to 5 minutes | 0 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 48 | 1 to less than 3 minutes | 2 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 1 to less than 3 minutes | 5 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | Less than 1 minute | 3 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 4 | 1 to less than 3 minutes | 7 Participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Parent/Guardian-reported Time for Study Drug Tablets to Dissolve | Week 24 | 3 to 5 minutes | 2 Participants |
Secondary
Percentage of Participants Who Experienced Virologic Failure Through Week 48
Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-naive | 33.3 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-experienced | 0.0 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Overall | 12.5 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-experienced | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Overall | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Overall | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-experienced | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Overall | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-experienced | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | Overall | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 48 | ART-experienced | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Experienced Virologic Failure Through Week 60
Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-experienced | 0.0 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Overall | 12.5 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-naive | 33.3 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-experienced | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Overall | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-experienced | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Overall | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-experienced | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Overall | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | Overall | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Experienced Virologic Failure Through Week 60 | ART-experienced | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | 10.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | 10.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Adverse Event Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | 90.9 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Adverse Event Through Week 60 | 90.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | 20.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | 20.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | 10.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
Time frame: Measured from treatment initiation through Week 60
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | 10.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60 | 0.0 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event Through Week 48
AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
Time frame: Measured from treatment initiation through Week 48
Population: All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With at Least One Adverse Event Through Week 48 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With at Least One Adverse Event Through Week 48 | 90.9 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With at Least One Adverse Event Through Week 48 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With at Least One Adverse Event Through Week 48 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With at Least One Adverse Event Through Week 48 | 90.0 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL
Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
Time frame: Weeks 4, 24, and 48
Population: All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24. One participant in Weight Band #4 discontinued study treatment between Weeks 24 and 48, so this participant was excluded from analysis at Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 24 | 87.5 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 4 | 75.0 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 48 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 24 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 4 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 48 | 100.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 48 | 100.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 4 | 100.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 24 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 24 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 4 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 48 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 24 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 4 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL | Week 48 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm
Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
Time frame: Weeks 4, 24, and 48
Population: All participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 66.7 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 88.9 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 77.8 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 91.7 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 100.0 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 91.7 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 100.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 100.0 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 100.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 90.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm
Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
Time frame: Weeks 4, 24, and 48
Population: All participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 44.4 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 77.8 percentage of participants |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 77.8 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 83.3 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 91.7 percentage of participants |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 66.7 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 93.3 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 86.7 percentage of participants |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 86.7 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 80.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 70.0 percentage of participants |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 24 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 4 | 100.0 percentage of participants |
| Weight Band #5 (25 kg or Greater at Study Entry) | Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm | Week 48 | 90.9 percentage of participants |
Secondary
Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | ABC | 10.40 L/hour |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | 3TC | 9.03 L/hour |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | DTG | 0.18 L/hour |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | DTG | 0.23 L/hour |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | ABC | 12.70 L/hour |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | 3TC | 8.04 L/hour |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | DTG | 0.35 L/hour |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | ABC | 17.40 L/hour |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | 3TC | 11.00 L/hour |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | ABC | 18.40 L/hour |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | 3TC | 13.80 L/hour |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | DTG | 0.37 L/hour |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | DTG | 0.69 L/hour |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | ABC | 23.00 L/hour |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC | 3TC | 14.80 L/hour |
Secondary
Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | ABC | 17.30 ug*h/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | 3TC | 9.97 ug*h/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | DTG | 82.20 ug*h/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | DTG | 86.90 ug*h/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | ABC | 18.90 ug*h/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | 3TC | 14.90 ug*h/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | DTG | 71.50 ug*h/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | ABC | 17.20 ug*h/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | 3TC | 13.60 ug*h/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | ABC | 19.50 ug*h/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | 3TC | 13.10 ug*h/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | DTG | 81.60 ug*h/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | DTG | 72.60 ug*h/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | ABC | 26.10 ug*h/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC | 3TC | 20.30 ug*h/mL |
Secondary
Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.01 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.08 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.35 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.02 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.02 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 0.71 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.01 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.02 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.09 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | DTG | 1.01 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | ABC | 0.02 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC | 3TC | 0.03 ug/mL |
Secondary
Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | 3TC | 0.01 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | DTG | 1.08 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | DTG | 1.35 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | ABC | 0.02 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | 3TC | 0.03 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | DTG | 0.71 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | 3TC | 0.02 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | ABC | 0.01 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | 3TC | 0.01 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | DTG | 1.09 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | DTG | 1.01 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | ABC | 0.02 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC | 3TC | 0.02 ug/mL |
Secondary
Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | ABC | 3.21 hours |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | 3TC | 3.38 hours |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | DTG | 8.34 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | DTG | 9.42 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | ABC | 3.43 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | 3TC | 3.23 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | DTG | 6.75 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | ABC | 3.72 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | 3TC | 2.97 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | ABC | 3.32 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | 3TC | 3.46 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | DTG | 8.34 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | DTG | 8.14 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | ABC | 3.30 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC | 3TC | 3.51 hours |
Secondary
Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 6.04 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.29 ug/mL |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 6.79 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 6.63 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 7.42 ug/mL |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.64 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 6.36 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 7.07 ug/mL |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.98 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 8.04 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 2.65 ug/mL |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 6.59 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | DTG | 5.43 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | ABC | 9.60 ug/mL |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC | 3TC | 3.59 ug/mL |
Secondary
Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC
Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
Time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
Population: All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | ABC | 1.00 hours |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | 3TC | 2.00 hours |
| Weight Band #1 (6 to Less Than 10 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | DTG | 2.00 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | DTG | 2.00 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | ABC | 1.00 hours |
| Weight Band #2 (10 to Less Than 14 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | 3TC | 2.00 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | DTG | 2.00 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | ABC | 1.00 hours |
| Weight Band #3 (14 to Less Than 20 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | 3TC | 2.00 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | ABC | 1.00 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | 3TC | 2.00 hours |
| Weight Band #4 (20 to Less Than 25 kg at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | DTG | 2.50 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | DTG | 3.00 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | ABC | 1.00 hours |
| Weight Band #5 (25 kg or Greater at Study Entry) | Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC | 3TC | 2.00 hours |