Trial Outcomes & Findings for The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age (NCT NCT03760458)

Last Updated: 2023-06-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

Results posted on

2023-06-27

Participant Flow

Accrual occurred between September 2020 and June 2021 in Botswana, South Africa, Thailand, and the United States at 14 different medical clinic sites.

Participant milestones

Participant milestones
Measure	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	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	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	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	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
Main Study (Through Week 48) STARTED	9	12	15	10	11
Main Study (Through Week 48) COMPLETED	8	11	15	10	11
Main Study (Through Week 48) NOT COMPLETED	1	1	0	0	0
Extended Follow-up (Weeks 48 Through 60) STARTED	0	0	4	3	3
Extended Follow-up (Weeks 48 Through 60) COMPLETED	0	0	4	3	3
Extended Follow-up (Weeks 48 Through 60) NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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	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
Main Study (Through Week 48) Withdrawal by Subject	1	1	0	0	0

Baseline Characteristics

CD4 was not collected at baseline for one participant in Weight Band #2.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=9 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=12 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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	Total n=57 Participants Total of all reporting groups
Age, Continuous	1.35 years n=9 Participants	3.56 years n=12 Participants	6.44 years n=15 Participants	8.41 years n=10 Participants	9.74 years n=11 Participants	6.38 years n=57 Participants
Age, Customized <6 years	9 Participants n=9 Participants	12 Participants n=12 Participants	7 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	28 Participants n=57 Participants
Age, Customized 6 to <12 years	0 Participants n=9 Participants	0 Participants n=12 Participants	8 Participants n=15 Participants	10 Participants n=10 Participants	11 Participants n=11 Participants	29 Participants n=57 Participants
Sex: Female, Male Female	5 Participants n=9 Participants	7 Participants n=12 Participants	5 Participants n=15 Participants	3 Participants n=10 Participants	6 Participants n=11 Participants	26 Participants n=57 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	5 Participants n=12 Participants	10 Participants n=15 Participants	7 Participants n=10 Participants	5 Participants n=11 Participants	31 Participants n=57 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	3 Participants n=11 Participants	3 Participants n=57 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants	12 Participants n=12 Participants	15 Participants n=15 Participants	10 Participants n=10 Participants	7 Participants n=11 Participants	53 Participants n=57 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	1 Participants n=11 Participants	1 Participants n=57 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants	1 Participants n=12 Participants	7 Participants n=15 Participants	4 Participants n=10 Participants	3 Participants n=11 Participants	18 Participants n=57 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Black or African American	6 Participants n=9 Participants	10 Participants n=12 Participants	7 Participants n=15 Participants	6 Participants n=10 Participants	8 Participants n=11 Participants	37 Participants n=57 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants	1 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=57 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=12 Participants	1 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=57 Participants
Region of Enrollment United States	0 Participants n=9 Participants	2 Participants n=12 Participants	2 Participants n=15 Participants	1 Participants n=10 Participants	5 Participants n=11 Participants	10 Participants n=57 Participants
Region of Enrollment Botswana	4 Participants n=9 Participants	2 Participants n=12 Participants	3 Participants n=15 Participants	2 Participants n=10 Participants	2 Participants n=11 Participants	13 Participants n=57 Participants
Region of Enrollment South Africa	2 Participants n=9 Participants	7 Participants n=12 Participants	4 Participants n=15 Participants	3 Participants n=10 Participants	1 Participants n=11 Participants	17 Participants n=57 Participants
Region of Enrollment Thailand	3 Participants n=9 Participants	1 Participants n=12 Participants	6 Participants n=15 Participants	4 Participants n=10 Participants	3 Participants n=11 Participants	17 Participants n=57 Participants
Weight	9.2 kilograms n=9 Participants	12.9 kilograms n=12 Participants	17.0 kilograms n=15 Participants	21.5 kilograms n=10 Participants	28.5 kilograms n=11 Participants	17.0 kilograms n=57 Participants
Pre-study Antiretroviral (ART) experience ART-experienced	6 Participants n=9 Participants	12 Participants n=12 Participants	15 Participants n=15 Participants	10 Participants n=10 Participants	11 Participants n=11 Participants	54 Participants n=57 Participants
Pre-study Antiretroviral (ART) experience ART-naive	3 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	3 Participants n=57 Participants
Known M184V mutation Yes	0 Participants n=9 Participants	0 Participants n=12 Participants	2 Participants n=15 Participants	0 Participants n=10 Participants	2 Participants n=11 Participants	4 Participants n=57 Participants
Known M184V mutation No	9 Participants n=9 Participants	12 Participants n=12 Participants	13 Participants n=15 Participants	10 Participants n=10 Participants	9 Participants n=11 Participants	53 Participants n=57 Participants
HIV-1 RNA <200 copies/mL	5 Participants n=9 Participants	12 Participants n=12 Participants	15 Participants n=15 Participants	10 Participants n=10 Participants	11 Participants n=11 Participants	53 Participants n=57 Participants
HIV-1 RNA ≥200 copies/mL	4 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	4 Participants n=57 Participants
CD4+ Cell Count	2321 cells/mm^3 n=9 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.	1452 cells/mm^3 n=11 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.	886 cells/mm^3 n=15 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.	1155 cells/mm^3 n=10 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.	915 cells/mm^3 n=11 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.	1201 cells/mm^3 n=56 Participants • CD4 was not collected at baseline for one participant in Weight Band #2.
CD4+ Percentage	34.0 percentage of CD4+ in total lymphocytes n=9 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.	33.9 percentage of CD4+ in total lymphocytes n=11 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.	32.9 percentage of CD4+ in total lymphocytes n=15 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.	32.6 percentage of CD4+ in total lymphocytes n=10 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.	37.7 percentage of CD4+ in total lymphocytes n=11 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.	35.1 percentage of CD4+ in total lymphocytes n=56 Participants • CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.
Total Cholesterol	4.01 mmol/L n=9 Participants	4.61 mmol/L n=12 Participants	4.51 mmol/L n=15 Participants	5.19 mmol/L n=10 Participants	4.27 mmol/L n=11 Participants	4.51 mmol/L n=57 Participants
High-Density Lipoprotein (HDL) Cholesterol	0.98 mmol/L n=9 Participants	1.53 mmol/L n=12 Participants	1.38 mmol/L n=15 Participants	1.67 mmol/L n=10 Participants	1.34 mmol/L n=11 Participants	1.37 mmol/L n=57 Participants
Low-Density Lipoprotein (LDL) Cholesterol	2.52 mmol/L n=9 Participants	2.25 mmol/L n=12 Participants	2.50 mmol/L n=15 Participants	3.04 mmol/L n=10 Participants	2.36 mmol/L n=11 Participants	2.52 mmol/L n=57 Participants
Triglycerides	1.71 mmol/L n=9 Participants	1.20 mmol/L n=12 Participants	1.23 mmol/L n=15 Participants	1.08 mmol/L n=10 Participants	1.76 mmol/L n=11 Participants	1.20 mmol/L n=57 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=7 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=7 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=7 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=7 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=7 Participants 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
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 46.0	14.2 h*ug/mL Geometric Coefficient of Variation 23.9	13.0 h*ug/mL Geometric Coefficient of Variation 15.6	14.5 h*ug/mL Geometric Coefficient of Variation 16.6	21.7 h*ug/mL Geometric Coefficient of Variation 26.2
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	19.8 h*ug/mL Geometric Coefficient of Variation 50.6	15.1 h*ug/mL Geometric Coefficient of Variation 40.3	17.4 h*ug/mL Geometric Coefficient of Variation 19.4	25.7 h*ug/mL Geometric Coefficient of Variation 14.6
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	91.0 h*ug/mL Geometric Coefficient of Variation 36.5	71.4 h*ug/mL Geometric Coefficient of Variation 23.5	84.4 h*ug/mL Geometric Coefficient of Variation 26.3	71.8 h*ug/mL Geometric Coefficient of Variation 13.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=7 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=7 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=7 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=7 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=7 Participants 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
Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC ABC	7.30 ug/mL Geometric Coefficient of Variation 20.5	8.36 ug/mL Geometric Coefficient of Variation 43.7	6.26 ug/mL Geometric Coefficient of Variation 31.0	6.65 ug/mL Geometric Coefficient of Variation 27.7	9.04 ug/mL Geometric Coefficient of Variation 21.9
Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC DTG	7.40 ug/mL Geometric Coefficient of Variation 28.0	8.85 ug/mL Geometric Coefficient of Variation 21.3	7.04 ug/mL Geometric Coefficient of Variation 17.0	7.29 ug/mL Geometric Coefficient of Variation 16.7	6.25 ug/mL Geometric Coefficient of Variation 20.6
Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC 3TC	2.29 ug/mL Geometric Coefficient of Variation 39.8	3.55 ug/mL Geometric Coefficient of Variation 18.7	2.92 ug/mL Geometric Coefficient of Variation 23.0	2.99 ug/mL Geometric Coefficient of Variation 31.9	4.15 ug/mL Geometric Coefficient of Variation 29.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=7 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=7 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=7 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=7 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=7 Participants 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
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	0.046 ug/mL Geometric Coefficient of Variation 48.3	0.058 ug/mL Geometric Coefficient of Variation 36.7	0.060 ug/mL Geometric Coefficient of Variation 18.3	0.084 ug/mL Geometric Coefficient of Variation 35.0
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	0.005 ug/mL Geometric Coefficient of Variation 127.4	0.003 ug/mL Geometric Coefficient of Variation 107.5	0.004 ug/mL Geometric Coefficient of Variation 84.9	0.011 ug/mL Geometric Coefficient of Variation 228.5
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	1.22 ug/mL Geometric Coefficient of Variation 77.5	0.79 ug/mL Geometric Coefficient of Variation 44.2	1.35 ug/mL Geometric Coefficient of Variation 95.5	0.98 ug/mL Geometric Coefficient of Variation 27.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Had at Least One Adverse Event Through Week 24	100.0 percentage of participants Interval 63.1 to 100.0	90.9 percentage of participants Interval 58.7 to 99.8	100.0 percentage of participants Interval 78.2 to 100.0	80.0 percentage of participants Interval 44.4 to 97.5	80.0 percentage of participants Interval 44.4 to 97.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24	0.0 percentage of participants Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC DTG	82.20 ug*h/mL Interval 65.6 to 103.0	86.90 ug*h/mL Interval 75.3 to 100.0	71.50 ug*h/mL Interval 62.1 to 82.2	81.60 ug*h/mL Interval 70.8 to 94.2	72.60 ug*h/mL Interval 64.9 to 81.1
Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC ABC	17.30 ug*h/mL Interval 12.0 to 25.1	18.90 ug*h/mL Interval 14.7 to 24.2	17.20 ug*h/mL Interval 14.8 to 20.0	19.50 ug*h/mL Interval 16.6 to 22.9	26.10 ug*h/mL Interval 22.5 to 30.2
Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC 3TC	9.97 ug*h/mL Interval 7.12 to 14.0	14.90 ug*h/mL Interval 10.6 to 20.9	13.60 ug*h/mL Interval 11.6 to 15.8	13.10 ug*h/mL Interval 11.2 to 15.2	20.30 ug*h/mL Interval 16.9 to 24.3

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC ABC	0.01 ug/mL Interval 0.002 to 0.021	0.02 ug/mL Interval 0.007 to 0.042	0.01 ug/mL Interval 0.008 to 0.021	0.01 ug/mL Interval 0.004 to 0.015	0.02 ug/mL Interval 0.01 to 0.038
Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC DTG	1.08 ug/mL Interval 0.67 to 1.74	1.35 ug/mL Interval 1.01 to 1.82	0.71 ug/mL Interval 0.478 to 1.05	1.09 ug/mL Interval 0.761 to 1.56	1.01 ug/mL Interval 0.772 to 1.32
Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC 3TC	0.01 ug/mL Interval 0.003 to 0.015	0.03 ug/mL Interval 0.01 to 0.085	0.02 ug/mL Interval 0.006 to 0.04	0.01 ug/mL Interval 0.003 to 0.028	0.02 ug/mL Interval 0.008 to 0.074

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC ABC	0.01 ug/mL Interval 0.003 to 0.018	0.02 ug/mL Interval 0.007 to 0.042	0.01 ug/mL Interval 0.007 to 0.024	0.01 ug/mL Interval 0.004 to 0.018	0.02 ug/mL Interval 0.01 to 0.04
Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC DTG	1.08 ug/mL Interval 0.67 to 1.74	1.35 ug/mL Interval 1.01 to 1.82	0.71 ug/mL Interval 0.48 to 1.05	1.09 ug/mL Interval 0.76 to 1.56	1.01 ug/mL Interval 0.77 to 1.32
Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC 3TC	0.01 ug/mL Interval 0.004 to 0.047	0.02 ug/mL Interval 0.005 to 0.053	0.01 ug/mL Interval 0.005 to 0.021	0.02 ug/mL Interval 0.007 to 0.043	0.03 ug/mL Interval 0.008 to 0.081

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC DTG	6.79 ug/mL Interval 5.92 to 7.8	6.63 ug/mL Interval 5.96 to 7.37	6.36 ug/mL Interval 5.9 to 6.85	6.59 ug/mL Interval 6.13 to 7.09	5.43 ug/mL Interval 4.91 to 6.02
Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC 3TC	2.29 ug/mL Interval 1.82 to 2.88	2.64 ug/mL Interval 2.12 to 3.29	2.98 ug/mL Interval 2.65 to 3.35	2.65 ug/mL Interval 2.16 to 3.25	3.59 ug/mL Interval 2.89 to 4.45
Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC ABC	6.04 ug/mL Interval 4.29 to 8.51	7.42 ug/mL Interval 5.75 to 9.57	7.07 ug/mL Interval 5.73 to 8.73	8.04 ug/mL Interval 6.27 to 10.3	9.60 ug/mL Interval 8.03 to 11.5

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC ABC	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 2.0	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0
Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC DTG	2.00 hours Interval 1.0 to 3.0	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 2.0 to 4.0	2.50 hours Interval 1.0 to 4.0	3.00 hours Interval 2.0 to 6.0
Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC 3TC	2.00 hours Interval 1.0 to 3.0	2.00 hours Interval 1.0 to 8.0	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC ABC	10.40 L/hour Interval 7.16 to 15.1	12.70 L/hour Interval 9.92 to 16.3	17.40 L/hour Interval 15.0 to 20.2	18.40 L/hour Interval 15.7 to 21.7	23.00 L/hour Interval 19.8 to 26.6
Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC DTG	0.18 L/hour Interval 0.15 to 0.23	0.23 L/hour Interval 0.2 to 0.27	0.35 L/hour Interval 0.3 to 0.4	0.37 L/hour Interval 0.32 to 0.42	0.69 L/hour Interval 0.62 to 0.77
Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC 3TC	9.03 L/hour Interval 6.45 to 12.6	8.04 L/hour Interval 5.74 to 11.3	11.00 L/hour Interval 9.46 to 12.9	13.80 L/hour Interval 11.8 to 16.0	14.80 L/hour Interval 12.3 to 17.7

SECONDARY outcome

Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC ABC	3.21 hours Interval 2.54 to 4.07	3.43 hours Interval 2.71 to 4.34	3.72 hours Interval 3.19 to 4.33	3.32 hours Interval 2.75 to 4.01	3.30 hours Interval 2.75 to 3.97
Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC DTG	8.34 hours Interval 6.68 to 10.4	9.42 hours Interval 7.91 to 11.2	6.75 hours Interval 5.82 to 7.83	8.34 hours Interval 6.72 to 10.4	8.14 hours Interval 7.0 to 9.46
Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC 3TC	3.38 hours Interval 2.54 to 4.48	3.23 hours Interval 2.5 to 4.16	2.97 hours Interval 2.52 to 3.49	3.46 hours Interval 2.64 to 4.52	3.51 hours Interval 2.64 to 4.66

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants With at Least One Adverse Event Through Week 48	100.0 percentage of participants Interval 63.1 to 100.0	90.9 percentage of participants Interval 58.7 to 99.8	100.0 percentage of participants Interval 78.2 to 100.0	100.0 percentage of participants Interval 69.2 to 100.0	90.0 percentage of participants Interval 55.5 to 99.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	20.0 percentage of participants Interval 2.5 to 55.6	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48	0.0 percentage of participants Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: Measured from treatment initiation through Week 48

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Had at Least One Adverse Event Through Week 60	100.0 percentage of participants Interval 63.1 to 100.0	90.9 percentage of participants Interval 58.7 to 99.8	100.0 percentage of participants Interval 78.2 to 100.0	100.0 percentage of participants Interval 69.2 to 100.0	90.0 percentage of participants Interval 55.5 to 99.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	20.0 percentage of participants Interval 2.5 to 55.6	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60	0.0 percentage of participants Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: Measured from treatment initiation through Week 60

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
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 Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 21.8	10.0 percentage of participants Interval 0.3 to 44.5	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Experienced Virologic Failure Through Week 48 ART-experienced	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Experienced Virologic Failure Through Week 48 Overall	12.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Experienced Virologic Failure Through Week 48 ART-naive	33.3 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Measured from treatment initiation through Week 60

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants Who Experienced Virologic Failure Through Week 60 Overall	12.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Experienced Virologic Failure Through Week 60 ART-experienced	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Who Experienced Virologic Failure Through Week 60 ART-naive	33.3 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL Week 4	75.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL Week 24	87.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL Week 48	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 24, and 48

Population: All participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=9 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=12 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
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 Interval 29.9 to 92.5	100.0 percentage of participants Interval 73.5 to 100.0	100.0 percentage of participants Interval 78.2 to 100.0	100.0 percentage of participants Interval 69.2 to 100.0	100.0 percentage of participants Interval 71.5 to 100.0
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 Interval 40.0 to 97.2	91.7 percentage of participants Interval 61.5 to 99.8	100.0 percentage of participants Interval 78.2 to 100.0	100.0 percentage of participants Interval 69.2 to 100.0	100.0 percentage of participants Interval 71.5 to 100.0
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 Interval 51.8 to 99.7	91.7 percentage of participants Interval 61.5 to 99.8	100.0 percentage of participants Interval 78.2 to 100.0	90.0 percentage of participants Interval 55.5 to 99.7	100.0 percentage of participants Interval 71.5 to 100.0

SECONDARY outcome

Timeframe: Weeks 4, 24, and 48

Population: All participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=9 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=12 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
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 Interval 13.7 to 78.8	91.7 percentage of participants Interval 61.5 to 99.8	86.7 percentage of participants Interval 59.5 to 98.3	80.0 percentage of participants Interval 44.4 to 97.5	100.0 percentage of participants Interval 71.5 to 100.0
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 Interval 40.0 to 97.2	83.3 percentage of participants Interval 51.6 to 97.9	93.3 percentage of participants Interval 68.1 to 99.8	100.0 percentage of participants Interval 69.2 to 100.0	100.0 percentage of participants Interval 71.5 to 100.0
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 Interval 40.0 to 97.2	66.7 percentage of participants Interval 34.9 to 90.1	86.7 percentage of participants Interval 59.5 to 98.3	70.0 percentage of participants Interval 34.8 to 93.3	90.9 percentage of participants Interval 58.7 to 99.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1, Q3) CD4+ Cell Count Week 4	3528 cells/mm^3 Interval 1458.0 to 4457.0	1385 cells/mm^3 Interval 1020.0 to 1761.0	812 cells/mm^3 Interval 716.0 to 1164.0	992 cells/mm^3 Interval 930.0 to 1408.0	841 cells/mm^3 Interval 627.0 to 1238.0
Median (Q1, Q3) CD4+ Cell Count Week 24	2208 cells/mm^3 Interval 1302.0 to 2939.0	1184 cells/mm^3 Interval 987.0 to 1810.0	894 cells/mm^3 Interval 689.0 to 1250.0	944 cells/mm^3 Interval 774.0 to 1047.0	920 cells/mm^3 Interval 675.0 to 1188.0
Median (Q1, Q3) CD4+ Cell Count Week 48	1853 cells/mm^3 Interval 1287.0 to 2700.0	1235 cells/mm^3 Interval 889.0 to 1591.0	930 cells/mm^3 Interval 791.0 to 1274.0	942 cells/mm^3 Interval 765.0 to 1194.0	777 cells/mm^3 Interval 681.0 to 825.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1, Q3) CD4+ Percentage Week 4	41.6 percentage of CD4+ in total lymphocytes Interval 31.4 to 43.6	33.9 percentage of CD4+ in total lymphocytes Interval 30.2 to 39.5	32.4 percentage of CD4+ in total lymphocytes Interval 27.8 to 39.7	34.4 percentage of CD4+ in total lymphocytes Interval 30.0 to 41.0	39.5 percentage of CD4+ in total lymphocytes Interval 38.2 to 41.0
Median (Q1, Q3) CD4+ Percentage Week 24	36.6 percentage of CD4+ in total lymphocytes Interval 29.3 to 40.3	35.2 percentage of CD4+ in total lymphocytes Interval 27.3 to 40.0	33.5 percentage of CD4+ in total lymphocytes Interval 25.9 to 40.1	37.7 percentage of CD4+ in total lymphocytes Interval 27.0 to 42.0	38.6 percentage of CD4+ in total lymphocytes Interval 36.0 to 44.1
Median (Q1, Q3) CD4+ Percentage Week 48	34.8 percentage of CD4+ in total lymphocytes Interval 29.5 to 42.6	34.1 percentage of CD4+ in total lymphocytes Interval 26.7 to 39.9	30.5 percentage of CD4+ in total lymphocytes Interval 29.3 to 41.0	33.5 percentage of CD4+ in total lymphocytes Interval 28.5 to 37.0	37.6 percentage of CD4+ in total lymphocytes Interval 34.0 to 41.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1,Q3) Change From Baseline in Total Cholesterol Baseline to Week 24	-0.31 mmol/L Interval -0.84 to 0.68	-0.70 mmol/L Interval -1.4 to 0.49	-0.67 mmol/L Interval -0.94 to 0.16	-0.32 mmol/L Interval -0.65 to 0.34	-0.18 mmol/L Interval -0.67 to 0.1
Median (Q1,Q3) Change From Baseline in Total Cholesterol Baseline to Week 48	0.00 mmol/L Interval -0.84 to 0.67	-0.50 mmol/L Interval -1.3 to 0.01	-0.68 mmol/L Interval -1.1 to -0.39	-0.25 mmol/L Interval -0.73 to 0.23	-0.09 mmol/L Interval -0.39 to 0.13

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1,Q3) Change From Baseline in HDL Baseline to Week 24	-0.01 mmol/L Interval -0.21 to 0.24	-0.06 mmol/L Interval -0.4 to 0.1	-0.19 mmol/L Interval -0.3 to 0.0	-0.15 mmol/L Interval -0.4 to 0.2	-0.06 mmol/L Interval -0.18 to 0.16
Median (Q1,Q3) Change From Baseline in HDL Baseline to Week 48	-0.10 mmol/L Interval -0.26 to 0.18	-0.20 mmol/L Interval -0.3 to 0.1	-0.24 mmol/L Interval -0.37 to -0.08	-0.19 mmol/L Interval -0.5 to 0.33	0.05 mmol/L Interval -0.01 to 0.13

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1,Q3) Change From Baseline in LDL Baseline to Week 48	0.05 mmol/L Interval -0.52 to 1.14	-0.13 mmol/L Interval -1.2 to 0.42	-0.30 mmol/L Interval -0.6 to 0.1	0.00 mmol/L Interval -0.18 to 0.13	0.03 mmol/L Interval -0.41 to 0.5
Median (Q1,Q3) Change From Baseline in LDL Baseline to Week 24	0.18 mmol/L Interval -0.78 to 0.52	-0.20 mmol/L Interval -0.7 to 0.31	-0.26 mmol/L Interval -0.7 to 0.11	-0.22 mmol/L Interval -0.6 to 0.25	-0.21 mmol/L Interval -0.73 to -0.03

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=10 Participants 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
Median (Q1,Q3) Change From Baseline in Triglycerides Baseline to Week 24	-0.51 mmol/L Interval -1.28 to 0.06	-0.51 mmol/L Interval -0.8 to -0.13	-0.17 mmol/L Interval -0.58 to 0.32	-0.20 mmol/L Interval -0.38 to 0.16	-0.24 mmol/L Interval -0.73 to 0.89
Median (Q1,Q3) Change From Baseline in Triglycerides Baseline to Week 48	-0.43 mmol/L Interval -0.97 to 0.07	-0.32 mmol/L Interval -0.9 to 0.3	-0.21 mmol/L Interval -0.6 to 0.2	0.00 mmol/L Interval -0.31 to 0.1	-0.27 mmol/L Interval -1.27 to -0.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Percent Adherence to Study Drug Week 4	100.0 percentage of study drug taken Interval 100.0 to 100.0	100.0 percentage of study drug taken Interval 100.0 to 100.0	100.0 percentage of study drug taken Interval 97.0 to 100.0	100.0 percentage of study drug taken Interval 100.0 to 100.0	100.0 percentage of study drug taken Interval 95.0 to 100.0
Parent/Guardian-reported Percent Adherence to Study Drug Week 24	100.0 percentage of study drug taken Interval 100.0 to 100.0	100.0 percentage of study drug taken Interval 95.0 to 100.0	100.0 percentage of study drug taken Interval 90.0 to 100.0	100.0 percentage of study drug taken Interval 90.0 to 100.0	100.0 percentage of study drug taken Interval 95.0 to 100.0
Parent/Guardian-reported Percent Adherence to Study Drug Week 48	100.0 percentage of study drug taken Interval 60.0 to 100.0	100.0 percentage of study drug taken Interval 90.0 to 100.0	100.0 percentage of study drug taken Interval 85.0 to 100.0	100.0 percentage of study drug taken Interval 100.0 to 100.0	100.0 percentage of study drug taken Interval 99.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Number of Missed Doses of Study Drug Week 4	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 1.0	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 1.0
Parent/Guardian-reported Number of Missed Doses of Study Drug Week 24	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 1.0	0 missed doses Interval 0.0 to 2.0	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 0.0
Parent/Guardian-reported Number of Missed Doses of Study Drug Week 48	0 missed doses Interval 0.0 to 5.0	0 missed doses Interval 0.0 to 6.0	0 missed doses Interval 0.0 to 5.0	0 missed doses Interval 0.0 to 0.0	0 missed doses Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · Both parents were admitted in the hospital	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · Caregiver too sick	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · Caregiver was too busy to give the medication	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · Change in daily routine	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · Forgot to administer medication	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	1 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 4 · No missed doses	8 Participants	10 Participants	14 Participants	10 Participants	10 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · Both parents were admitted in the hospital	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · Caregiver too sick	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · Caregiver was too busy to give the medication	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · Change in daily routine	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · Forgot to administer medication	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 24 · No missed doses	7 Participants	8 Participants	13 Participants	9 Participants	10 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · Both parents were admitted in the hospital	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · Caregiver too sick	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · Caregiver was too busy to give the medication	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · Change in daily routine	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · Forgot to administer medication	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Reason for Missed Doses of Study Drug Week 48 · No missed doses	5 Participants	9 Participants	14 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
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	0 Participants	0 Participants	0 Participants	0 Participants
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	4 Participants	2 Participants	2 Participants	2 Participants
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	7 Participants	12 Participants	7 Participants	9 Participants
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	0 Participants	1 Participants	1 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	7 Participants	10 Participants	5 Participants	9 Participants
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	3 Participants	4 Participants	1 Participants	2 Participants
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	1 Participants	1 Participants	3 Participants	0 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants
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	7 Participants	12 Participants	7 Participants	11 Participants
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	3 Participants	2 Participants	1 Participants	0 Participants
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	1 Participants	1 Participants	1 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
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	9 Participants	14 Participants	10 Participants	10 Participants
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	0 Participants	1 Participants	0 Participants	1 Participants
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	1 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	1 Participants	0 Participants	0 Participants	0 Participants
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	9 Participants	12 Participants	6 Participants	9 Participants
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	2 Participants	3 Participants	2 Participants	2 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	1 Participants	0 Participants
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	7 Participants	13 Participants	9 Participants	11 Participants
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	3 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	1 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants
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	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, and 48

Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Ease of Giving Study Drug Week 4 · The child takes by themselves easily	0 Participants	2 Participants	11 Participants	9 Participants	9 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 4 · The child takes easily with help	6 Participants	8 Participants	4 Participants	0 Participants	2 Participants
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	1 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 4 · You need to hold and force the child	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 12 · The child takes by themselves easily	0 Participants	5 Participants	10 Participants	7 Participants	9 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 12 · The child takes easily with help	8 Participants	5 Participants	5 Participants	2 Participants	2 Participants
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	1 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 12 · You need to hold and force the child	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 24 · The child takes by themselves easily	0 Participants	3 Participants	12 Participants	8 Participants	8 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 24 · The child takes easily with help	8 Participants	6 Participants	3 Participants	2 Participants	3 Participants
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	2 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 24 · You need to hold and force the child	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 48 · The child takes by themselves easily	0 Participants	4 Participants	10 Participants	6 Participants	10 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 48 · The child takes easily with help	8 Participants	5 Participants	4 Participants	2 Participants	1 Participants
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	1 Participants	1 Participants	1 Participants	0 Participants
Parent/Guardian-reported Ease of Giving Study Drug Week 48 · You need to hold and force the child	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, and 48

Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 48 · Very good	3 Participants	5 Participants	5 Participants	3 Participants	6 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 48 · Good	2 Participants	4 Participants	6 Participants	3 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 48 · Average	3 Participants	1 Participants	1 Participants	1 Participants	5 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 48 · Bad	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 48 · Very bad	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 4 · Very good	1 Participants	5 Participants	0 Participants	2 Participants	5 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 4 · Good	1 Participants	4 Participants	10 Participants	2 Participants	2 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 4 · Average	4 Participants	2 Participants	4 Participants	3 Participants	4 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 4 · Bad	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 4 · Very bad	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 12 · Very good	2 Participants	3 Participants	4 Participants	3 Participants	6 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 12 · Good	2 Participants	3 Participants	5 Participants	3 Participants	2 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 12 · Average	4 Participants	4 Participants	3 Participants	2 Participants	3 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 12 · Bad	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 12 · Very bad	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 24 · Very good	2 Participants	5 Participants	5 Participants	3 Participants	6 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 24 · Good	3 Participants	3 Participants	4 Participants	2 Participants	4 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 24 · Average	2 Participants	3 Participants	3 Participants	3 Participants	1 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 24 · Bad	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Study Drug Week 24 · Very bad	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, and 48

Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	Weight Band #5 (25 kg or Greater at Study Entry) n=11 Participants 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
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 4 · Very good	3 Participants	7 Participants	4 Participants	4 Participants	8 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 4 · Good	4 Participants	3 Participants	9 Participants	3 Participants	2 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 4 · Average	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 4 · Bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 4 · Very bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 12 · Very good	4 Participants	6 Participants	7 Participants	6 Participants	10 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 12 · Good	1 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 12 · Average	3 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 12 · Bad	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 12 · Very bad	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 24 · Very good	6 Participants	6 Participants	8 Participants	6 Participants	10 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 24 · Good	1 Participants	4 Participants	5 Participants	2 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 24 · Average	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 24 · Bad	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 24 · Very bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 48 · Very good	8 Participants	7 Participants	9 Participants	7 Participants	11 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 48 · Good	0 Participants	4 Participants	6 Participants	2 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 48 · Average	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 48 · Bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parent/Guardian-reported Response of Child's Face When Taking Favorite Food Week 48 · Very bad	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	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
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 48 · 1 to less than 3 minutes	3 Participants	6 Participants	11 Participants	2 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 4 · Less than 1 minute	3 Participants	5 Participants	0 Participants	2 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 4 · 1 to less than 3 minutes	3 Participants	5 Participants	11 Participants	7 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 4 · 3 to 5 minutes	2 Participants	1 Participants	4 Participants	1 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 12 · Less than 1 minute	2 Participants	2 Participants	4 Participants	1 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 12 · 1 to less than 3 minutes	5 Participants	7 Participants	8 Participants	6 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 12 · 3 to 5 minutes	1 Participants	2 Participants	3 Participants	3 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 24 · Less than 1 minute	2 Participants	5 Participants	4 Participants	3 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 24 · 1 to less than 3 minutes	5 Participants	6 Participants	10 Participants	5 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 24 · 3 to 5 minutes	1 Participants	0 Participants	1 Participants	2 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 48 · Less than 1 minute	3 Participants	4 Participants	2 Participants	2 Participants	—
Parent/Guardian-reported Time for Study Drug Tablets to Dissolve Week 48 · 3 to 5 minutes	2 Participants	1 Participants	2 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, and 48

Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=8 Participants 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	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=11 Participants 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	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 Participants 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	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 Participants 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	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
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 4 · It is too few	0 Participants	0 Participants	0 Participants	0 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 12 · It is acceptable	8 Participants	11 Participants	15 Participants	9 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 12 · It is too many	0 Participants	0 Participants	0 Participants	1 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 12 · It is too few	0 Participants	0 Participants	0 Participants	0 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 24 · It is acceptable	8 Participants	10 Participants	14 Participants	10 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 4 · It is acceptable	7 Participants	10 Participants	15 Participants	8 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 4 · It is too many	1 Participants	1 Participants	0 Participants	2 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 24 · It is too many	0 Participants	1 Participants	1 Participants	0 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 24 · It is too few	0 Participants	0 Participants	0 Participants	0 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 48 · It is acceptable	7 Participants	11 Participants	15 Participants	4 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 48 · It is too many	0 Participants	0 Participants	0 Participants	0 Participants	—
Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve Week 48 · It is too few	1 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 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.

ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.

Outcome measures

Outcome measures
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=1 Participants 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	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	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	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	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
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase K14R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase A21T	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V31I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V72I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase L74I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase T112V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V113I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase T125A	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V126L	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase G134N	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase I135V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase K136R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V165I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase A196P	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V236I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase V281M	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Integrase S283G	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease L10V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease I13V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease G16E	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease E35D	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease M36I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease R41K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease K43R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease H69K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease I72V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Protease L89M	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase E6D	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K11T	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K20R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase V35T	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase T39K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K43E	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase Q102K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K122E	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase D123S	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase C162S	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase T165I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K173A	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase Q174K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase D177E	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase T200A	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase I202V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase Q207A	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase L210M	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase R211S	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase V245E	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase A272P	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase R277K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase T286A	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase L295L/I	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase E312N	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase I326V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase I329V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase G335D	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase M357K	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K358R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase G359S	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K366R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase A371V	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase T377S	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K390R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase K395R	1 Participants	—	—	—	—
Antiretroviral (ARV) Resistance Mutations Entry Visit: Reverse Transcriptase A400T	1 Participants	—	—	—	—

Adverse Events

Weight Band #1 (6 to Less Than 10 kg at Study Entry)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Weight Band #2 (10 to Less Than 14 kg at Study Entry)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Weight Band #3 (14 to Less Than 20 kg at Study Entry)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Weight Band #4 (20 to Less Than 25 kg at Study Entry)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Weight Band #5 (25 kg or Greater at Study Entry)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=9 participants at risk 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.	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=12 participants at risk 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.	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 participants at risk 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.	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 participants at risk 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.	Weight Band #5 (25 kg or Greater at Study Entry) n=11 participants at risk Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Gastroenteritis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Pneumonia	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study

Other adverse events

Other adverse events
Measure	Weight Band #1 (6 to Less Than 10 kg at Study Entry) n=9 participants at risk 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.	Weight Band #2 (10 to Less Than 14 kg at Study Entry) n=12 participants at risk 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.	Weight Band #3 (14 to Less Than 20 kg at Study Entry) n=15 participants at risk 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.	Weight Band #4 (20 to Less Than 25 kg at Study Entry) n=10 participants at risk 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.	Weight Band #5 (25 kg or Greater at Study Entry) n=11 participants at risk Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.
Blood and lymphatic system disorders Anaemia	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Blood and lymphatic system disorders Eosinophilia	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Blood and lymphatic system disorders Lymphadenopathy	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Blood and lymphatic system disorders Neutropenia	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	27.3% 3/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Blood and lymphatic system disorders Secondary thrombocytosis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Cardiac disorders Tachycardia	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Ear and labyrinth disorders Otorrhoea	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Eye disorders Conjunctival pallor	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Abdominal discomfort	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Abdominal tenderness	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Dental caries	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Flatulence	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Gingival swelling	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Nausea	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Stomatitis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Gastrointestinal disorders Vomiting	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Facial pain	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Feeling hot	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Malaise	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Non-cardiac chest pain	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Pyrexia	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	16.7% 2/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
General disorders Swelling face	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Hepatobiliary disorders Hepatomegaly	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Bronchiolitis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations COVID-19	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Cellulitis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Gastroenteritis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Lower respiratory tract infection	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Nasopharyngitis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	20.0% 3/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Otitis media chronic	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Pharyngitis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Pneumonia	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Subcutaneous abscess	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Tinea capitis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Tinea faciei	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Tonsillitis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Upper respiratory tract infection	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	25.0% 3/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Infections and infestations Viral upper respiratory tract infection	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Injury, poisoning and procedural complications Adverse event following immunisation	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Injury, poisoning and procedural complications Contusion	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Alanine aminotransferase increased	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	25.0% 3/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	53.3% 8/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	70.0% 7/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Aspartate aminotransferase increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	16.7% 2/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	33.3% 5/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	40.0% 4/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	18.2% 2/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood alkaline phosphatase increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood bilirubin increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood cholesterol increased	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	20.0% 3/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	30.0% 3/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	18.2% 2/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood creatinine increased	44.4% 4/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	50.0% 6/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	40.0% 6/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	50.0% 5/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	45.5% 5/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood pressure increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood pressure systolic increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Blood triglycerides increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Creatinine renal clearance decreased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	25.0% 3/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Glomerular filtration rate decreased	66.7% 6/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	41.7% 5/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	60.0% 9/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	90.0% 9/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	63.6% 7/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Gamma-glutamyltransferase increased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Haemoglobin decreased	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Low density lipoprotein increased	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	20.0% 2/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Neutrophil count decreased	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Investigations Platelet count decreased	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Metabolism and nutrition disorders Abnormal loss of weight	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Metabolism and nutrition disorders Decreased appetite	44.4% 4/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	16.7% 2/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Metabolism and nutrition disorders Malnutrition	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Metabolism and nutrition disorders Underweight	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	26.7% 4/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Nervous system disorders Dizziness	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Nervous system disorders Headache	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Nervous system disorders Lethargy	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Nervous system disorders Somnolence	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Psychiatric disorders Nightmare	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Renal and urinary disorders Dysuria	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Childhood asthma	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Cough	66.7% 6/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	50.0% 6/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	33.3% 5/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	18.2% 2/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.2% 2/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	16.7% 2/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Nasal flaring	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Productive cough	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	13.3% 2/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	44.4% 4/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	25.0% 3/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	20.0% 3/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	18.2% 2/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	10.0% 1/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Tonsillar exudate	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Tonsillar inflammation	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	9.1% 1/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	8.3% 1/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	6.7% 1/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study
Skin and subcutaneous tissue disorders Skin plaque	11.1% 1/9 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/12 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/15 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/10 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study	0.00% 0/11 • From study entry to study completion (at Week 48 or 60) or premature study discontinuation All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study

Additional Information

IMPAACT Clinicaltrials.gov Coordinator

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER