| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 | | OG004 | 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 |
| | | Title | Denominators | Categories |
|---|
| Abacavir (ABC) | | | Title | Measurements |
|---|
| - OG00017.7± 33.8
- OG00119.8± 50.6
- OG00215.1± 40.3
- OG003
|
|
| |
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Weight Band #2 (10 to Less Than 14 kg at Study Entry) |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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). | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | ug*h/mL | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | ug/mL | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ug/mL | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | ug/mL | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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 | Posted | | Median | Full Range | hours | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | L/hour | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Measured from Week 1 through Week 48 over 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | | percentage of participants | | Measured from treatment initiation through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | | percentage of participants | | Measured from treatment initiation through Week 60 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Number | | percentage of participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | All participants who received at least one dose of study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | All participants who received at least one dose of study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | percentage of CD4+ in total lymphocytes | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Median | Inter-Quartile Range | mmol/L | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | 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. | Posted | | Median | Full Range | percentage of study drug taken | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Median | Full Range | missed doses | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Parent/Guardian-reported Ease of Giving Study Drug | Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Antiretroviral (ARV) Resistance Mutations | ARV resistance mutations at time of virologic failure and at entry for children with virologic failure. | 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. | Posted | | Count of Participants | | Participants | | Entry and confirmation of virologic failure | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|