Trial Outcomes & Findings for A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir (NCT NCT00950859)

Last Updated: 2015-12-04

Results Overview

The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Baseline (Day 1) and Day 11

Results posted on

2015-12-04

Participant Flow

Participants recruited initially to Cohort I and subsequently to Cohort II. Recruitment to Cohort I was closed 9 months before recruitment to Cohort II was opened. Recruitment was not randomized.

Participant milestones

Participant milestones
Measure	Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID).
Overall Study STARTED	27	24
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID).
Overall Study Adverse Event	3	3
Overall Study Insufficient Viral Load Response	12	3
Overall Study Protocol Violation	1	1
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).	Total n=51 Participants Total of all reporting groups
Age, Customized Years	48 Years n=5 Participants	47 Years n=7 Participants	47 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 11

Population: Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11	21 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion

Population: ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).

Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 72, n=14, 18	-2.10 Log10 copies/mL Standard Deviation 1.03	-2.71 Log10 copies/mL Standard Deviation 0.82
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 96, n=13, 15	-2.06 Log10 copies/mL Standard Deviation 1.13	-2.58 Log10 copies/mL Standard Deviation 0.77
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 108, n= 13, 17	-1.95 Log10 copies/mL Standard Deviation 1.20	-2.69 Log10 copies/mL Standard Deviation 0.82
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 180, n= 11, 10	-1.76 Log10 copies/mL Standard Deviation 1.11	-2.56 Log10 copies/mL Standard Deviation 0.82
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 192, n= 9, 7	-1.87 Log10 copies/mL Standard Deviation 1.16	-2.51 Log10 copies/mL Standard Deviation 0.98
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 216, n= 9, 6	-1.61 Log10 copies/mL Standard Deviation 1.08	-2.35 Log10 copies/mL Standard Deviation 0.71
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 228, n= 6, 4	-1.79 Log10 copies/mL Standard Deviation 1.08	-2.33 Log10 copies/mL Standard Deviation 0.90
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 240, n= 7, 0	-1.63 Log10 copies/mL Standard Deviation 1.13	NA Log10 copies/mL Standard Deviation NA Since 0 participants were analyzed, no data to present.
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 252, n= 4, 0	-1.72 Log10 copies/mL Standard Deviation 1.07	NA Log10 copies/mL Standard Deviation NA Since 0 participants were analyzed, no data to present.
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Day 6 to 8, n=27, 24	-1.31 Log10 copies/mL Standard Deviation 0.71	-1.40 Log10 copies/mL Standard Deviation 0.43
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Day 11, n=27, 24	-1.45 Log10 copies/mL Standard Deviation 0.77	-1.76 Log10 copies/mL Standard Deviation 0.53
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 4, n=26, 24	-1.82 Log10 copies/mL Standard Deviation 1.03	-2.06 Log10 copies/mL Standard Deviation 0.78
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 12, n=22, 24	-1.94 Log10 copies/mL Standard Deviation 1.14	-2.30 Log10 copies/mL Standard Deviation 0.93
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 24, n=18, 22	-1.99 Log10 copies/mL Standard Deviation 1.08	-2.50 Log10 copies/mL Standard Deviation 0.81
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 48, n=15, 20	-2.02 Log10 copies/mL Standard Deviation 1.07	-2.63 Log10 copies/mL Standard Deviation 0.78
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 120, n= 11, 17	-2.09 Log10 copies/mL Standard Deviation 1.15	-2.67 Log10 copies/mL Standard Deviation 0.85
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 132, n= 11, 17	-1.83 Log10 copies/mL Standard Deviation 1.01	-2.66 Log10 copies/mL Standard Deviation 0.86
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 144, n= 12, 15	-2.08 Log10 copies/mL Standard Deviation 1.29	-2.62 Log10 copies/mL Standard Deviation 0.94
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 156, n= 12, 15	-2.04 Log10 copies/mL Standard Deviation 1.36	-2.65 Log10 copies/mL Standard Deviation 0.77
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 168, n= 11, 14	-1.77 Log10 copies/mL Standard Deviation 1.26	-2.72 Log10 copies/mL Standard Deviation 0.89
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 204, n= 10, 6	-1.76 Log10 copies/mL Standard Deviation 1.21	-2.35 Log10 copies/mL Standard Deviation 0.71
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion Week 264, n= 1, 0	-2.90 Log10 copies/mL Standard Deviation NA As only 1 participant was analyzed; therefore, no SD to present.	NA Log10 copies/mL Standard Deviation NA Since 0 participants were analyzed, no data to present.

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, 24, 48, 72, and 96

Population: ITT-E Population

The number of participants with plasma HIV-1 RNA \<400 c/mL or \<50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 48, <50 c/mL	9 Participants	17 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 72, <400 c/mL	12 Participants	NA Participants As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analysed using TLOVR.
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Baseline, <50 c/mL	0 Participants	0 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 4, <50 c/mL	9 Participants	12 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 12, <50 c/mL	13 Participants	16 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 24, <50 c/mL	11 Participants	19 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 72, <50 c/mL	8 Participants	NA Participants As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analyzed using TLOVR.
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 96, <50 c/mL	7 Participants	NA Participants As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analyzed using TLOVR.
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Baseline, <400 c/mL	0 Participants	0 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 4, <400 c/mL	16 Participants	17 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 12, <400 c/mL	16 Participants	20 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 24, <400 c/mL	14 Participants	20 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 48, <400 c/mL	13 Participants	18 Participants
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis. Week 96, <400 c/mL	10 Participants	NA Participants As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analysed using TLOVR.

SECONDARY outcome

Timeframe: From Week 48 every 12 weeks up to study completion

Population: ITT-E Population

The number of participants with plasma HIV-1 RNA \<400 c/mL or \<50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 60, <50 c/mL, n=13, 18	69 Percentage of Participants	94 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 72, <50 c/mL, n=14, 18	64 Percentage of Participants	78 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 84, <50 c/mL, n=14, 18	57 Percentage of Participants	78 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 96, <50 c/mL, n=13, 15	54 Percentage of Participants	87 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 108, <50 c/mL, n=13, 17	54 Percentage of Participants	88 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 120, <50 c/mL, n=11, 17	55 Percentage of Participants	88 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 132, <50 c/mL, n=11, 17	55 Percentage of Participants	82 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 144, <50 c/mL, n=12, 15	58 Percentage of Participants	87 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 156, <50 c/mL, n=12, 15	67 Percentage of Participants	93 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 168, <50 c/mL, n=11, 14	64 Percentage of Participants	86 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 180, <50 c/mL, n=11, 10	64 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 192, <50 c/mL, n= 9, 7	67 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 204, <50 c/mL, n= 10, 6	50 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 216, <50 c/mL, n= 9, 6	56 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 228, <50 c/mL, n=6, 4	67 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 240, <50 c/mL, n=7,0	57 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 252, <50 c/mL, n=4, 0	50 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 264, <50 c/mL, n=1, 0	100 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 48, <400 c/mL, n=15, 20	73 Percentage of Participants	95 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 60,<400 c/mL, n=13, 18	92 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 72,<400 c/mL, n=14, 18	79 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 84,<400 c/mL, n=14, 18	71 Percentage of Participants	94 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 96,<400 c/mL, n=13, 15	85 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 108,<400 c/mL, n=13,17	85 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 120,<400 c/mL, n=11, 17	82 Percentage of Participants	94 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 132,<400 c/mL, n=11,17	82 Percentage of Participants	94 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 144,<400 c/mL, n=12, 15	83 Percentage of Participants	93 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 156,<400 c/mL, n=12, 15	75 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 168,<400 c/mL, n=11, 14	82 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 180,<400 c/mL, n=11, 10	73 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 192,<400 c/mL, n=9, 7	78 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 204,<400 c/mL, n=10, 6	70 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 216,<400 c/mL, n=9, 6	56 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 228,<400 c/mL, n=6, 4	67 Percentage of Participants	100 Percentage of Participants
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 240,<400 c/mL, n=7, 0	71 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 252,<400 c/mL, n=4, 0	50 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 264,<400 c/mL, n=1, 0	100 Percentage of Participants	NA Percentage of Participants Since 0 participants were analyzed, no value to present.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion Week 48, <50 c/mL, n=15, 20	60 Percentage of Participants	80 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion

Population: ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).

Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Baseline, n=27, 24	114 cells per cubic millimeter (mm^3) Interval 44.0 to 227.0	202 cells per cubic millimeter (mm^3) Interval 19.0 to 384.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Day 11, n=27, 24	34 cells per cubic millimeter (mm^3) Interval 2.0 to 71.0	14 cells per cubic millimeter (mm^3) Interval 0.0 to 69.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 4, n=27, 24	57 cells per cubic millimeter (mm^3) Interval 33.0 to 108.0	35 cells per cubic millimeter (mm^3) Interval 8.0 to 69.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 12, n= 22, 24	84 cells per cubic millimeter (mm^3) Interval 26.0 to 124.0	57 cells per cubic millimeter (mm^3) Interval 8.0 to 103.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 24, n=17, 22	78 cells per cubic millimeter (mm^3) Interval 54.0 to 175.0	79 cells per cubic millimeter (mm^3) Interval 17.0 to 147.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 48, n=15, 20	102 cells per cubic millimeter (mm^3) Interval 29.0 to 160.0	106 cells per cubic millimeter (mm^3) Interval 45.0 to 245.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 72, n=14, 18	163 cells per cubic millimeter (mm^3) Interval 58.0 to 204.0	191.5 cells per cubic millimeter (mm^3) Interval 80.0 to 277.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 96, n=13, 15	142 cells per cubic millimeter (mm^3) Interval 75.0 to 202.0	189 cells per cubic millimeter (mm^3) Interval 75.0 to 280.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 108, n=13, 17	124 cells per cubic millimeter (mm^3) Interval 68.0 to 249.0	155 cells per cubic millimeter (mm^3) Interval 91.0 to 276.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 120, n=11, 17	221 cells per cubic millimeter (mm^3) Interval 62.0 to 306.0	221 cells per cubic millimeter (mm^3) Interval 135.0 to 314.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 132, n=11, 17	97 cells per cubic millimeter (mm^3) Interval 26.0 to 303.0	158 cells per cubic millimeter (mm^3) Interval 129.0 to 384.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 144, n=12, 15	121 cells per cubic millimeter (mm^3) Interval 28.0 to 284.0	278 cells per cubic millimeter (mm^3) Interval 113.0 to 340.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 156, n=12, 15	212 cells per cubic millimeter (mm^3) Interval 64.0 to 378.0	223 cells per cubic millimeter (mm^3) Interval 131.0 to 309.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 168, n=11, 13	97 cells per cubic millimeter (mm^3) Interval -102.0 to 365.0	271 cells per cubic millimeter (mm^3) Interval 93.0 to 357.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 180, n=11, 10	125 cells per cubic millimeter (mm^3) Interval 55.0 to 327.0	224 cells per cubic millimeter (mm^3) Interval 163.0 to 288.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 192, n=10, 7	94 cells per cubic millimeter (mm^3) Interval 61.0 to 291.0	343 cells per cubic millimeter (mm^3) Interval 304.0 to 429.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 204, n=10, 6	92 cells per cubic millimeter (mm^3) Interval 47.0 to 364.0	264 cells per cubic millimeter (mm^3) Interval 186.0 to 370.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 216, n=9, 6	172 cells per cubic millimeter (mm^3) Interval 48.0 to 416.0	252 cells per cubic millimeter (mm^3) Interval 147.0 to 421.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 228, n=7, 3	148 cells per cubic millimeter (mm^3) Interval 66.0 to 357.0	417 cells per cubic millimeter (mm^3) Interval -12.0 to 633.0
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 240, n=7, 0	158 cells per cubic millimeter (mm^3) Interval 119.0 to 470.0	NA cells per cubic millimeter (mm^3) Since 0 participants were analyzed, no data to present.
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 252, n=4, 0	157 cells per cubic millimeter (mm^3) Interval 109.0 to 282.0	NA cells per cubic millimeter (mm^3) Since 0 participants were analyzed, no data to present.
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion Week 264, n=1, 0	560 cells per cubic millimeter (mm^3) Interval 560.0 to 560.0	NA cells per cubic millimeter (mm^3) Since 0 participants were analyzed, no data to present.

SECONDARY outcome

Timeframe: Day 10

Population: Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration

The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=25 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=23 Participants Participants received DTG 50 mg twice a day (BID).
Cmax, Cmin, and Ctau of DTG Cmax	3.04 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 38	5.41 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 40
Cmax, Cmin, and Ctau of DTG Ctau	0.69 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 91	2.72 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 70
Cmax, Cmin, and Ctau of DTG Cmin	0.48 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 136	2.61 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 67

SECONDARY outcome

Timeframe: Day 10; Weeks 4 and 24

Population: PK Parameter Population

The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=25 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=23 Participants Participants received DTG 50 mg twice a day (BID).
C0 Assessment of DTG C0, Day 10	0.51 µg/mL Geometric Coefficient of Variation 139	3.20 µg/mL Geometric Coefficient of Variation 69
C0 Assessment of DTG C0, Week 4	0.57 µg/mL Geometric Coefficient of Variation 100	2.55 µg/mL Geometric Coefficient of Variation 63
C0 Assessment of DTG C0, Week 24	0.38 µg/mL Geometric Coefficient of Variation 114	2.38 µg/mL Geometric Coefficient of Variation 69

SECONDARY outcome

Timeframe: Day 10

Population: PK Parameter Population

The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=25 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=23 Participants Participants received DTG 50 mg twice a day (BID).
Tmax of DTG	2.97 Hours Interval 1.97 to 7.92	2.00 Hours Interval 0.0 to 7.87

SECONDARY outcome

Timeframe: Day 10

Population: PK Parameter Population

AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=25 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=23 Participants Participants received DTG 50 mg twice a day (BID).
AUC0-24 Assessment of DTG	36.46 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 53	93.36 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 50

SECONDARY outcome

Timeframe: From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)

Population: ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.

The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category B, Candidiasis, oropharyngeal	3 Participants	2 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category B, Herpes Zoster	2 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Herpes simplex	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Candidiasis, esophageal	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Cytomegalovirus retinitis	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Lymphoma, immunoblastic	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category B, Hairy leukoplakia, oral	2 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Lymphoma, Burkitt's	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Category C, Kaposi's sarcoma	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Brain mass	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Completed suicide	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Febrile bone marrow aplasia	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Immunoblastic lymphoma	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Acute pulmonary oedema	1 Participants	0 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Anaemia	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Haemochromatosis	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Death, Hepatic fibrosis	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Other: Cryptosporidiosis, acute intestinal	0 Participants	1 Participants
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences Other: leukoplasia of both side of the tongue	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)

Population: ITT-E Population.

The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death From CDC class A to CDC class C	0 Participants	2 Participants
Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death From CDC class B to CDC class C	0 Participants	2 Participants
Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death From CDC class C to new CDC class C	1 Participants	0 Participants
Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death From CDC Class A, B, or C to death	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion

Population: ITT-E Population

PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log10 c/mL unless \<400 c/mL or an increase of \>= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 132	16 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 60	13 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 72	14 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 120	16 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 216	17 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 84	15 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 32	12 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 40	12 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 48	13 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 96	16 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 108	16 Participants	6 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 144	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 156	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 168	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 180	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 192	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 204	16 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 228	18 Participants	7 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 240	18 Participants	NA Participants No data were available for analysis from Cohort II at the time points.
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 252	18 Participants	NA Participants No data were available for analysis from Cohort II at the time points.
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 264	18 Participants	NA Participants No data were available for analysis from Cohort II at the time points.
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Day 11	6 Participants	1 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 8	7 Participants	3 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 12	9 Participants	3 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 16	10 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 20	10 Participants	5 Participants
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion Week 24	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline

Population: ITT-E Population

At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated Genotypic Resistance at Baseline N155	4 Participants	6 Participants
Number of Participants With the Indicated Genotypic Resistance at Baseline Q148 + 2	3 Participants	2 Participants
Number of Participants With the Indicated Genotypic Resistance at Baseline Q 148 + 1	4 Participants	8 Participants
Number of Participants With the Indicated Genotypic Resistance at Baseline Mixture	2 Participants	1 Participants
Number of Participants With the Indicated Genotypic Resistance at Baseline Y143	12 Participants	6 Participants
Number of Participants With the Indicated Genotypic Resistance at Baseline Other	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: ITT-E Population

Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group Y143, n=12, 6	1.1 Percentage Interval 0.6 to 1.4	1.2 Percentage Interval 0.92 to 1.8
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group Q148 + 2, n=3, 2	21 Percentage Interval 14.0 to 35.0	4 Percentage Interval 2.1 to 6.0
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group Q148 + 1, n=4, 8	5.5 Percentage Interval 3.3 to 25.0	5.5 Percentage Interval 4.1 to 8.2
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group Mixture, n=2, 1	7.8 Percentage Interval 6.5 to 9.1	9.48 Percentage Interval 9.48 to 9.48
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group N155, n=4, 6	1.8 Percentage Interval 1.5 to 5.1	2.3 Percentage Interval 1.3 to 4.0
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group Other, n=2, 1	1.2 Percentage Interval 0.9 to 1.5	0.87 Percentage Interval 0.87 to 0.87

SECONDARY outcome

Timeframe: From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)

Population: On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)

An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log10 c/mL unless \<400 c/mL or an increase of \>= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=18 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=7 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance Any	11 Participants	5 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance E138T	0 Participants	1 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance G140S	3 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance L74I/M	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance E138E/K	1 Participants	2 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance L74M	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance L74I	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance T97T/A	0 Participants	2 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance Q148R	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance S147G	3 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance L68L/I	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance E92E/Q	0 Participants	1 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance N155H	3 Participants	4 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance T97A	2 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance Q148H	2 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance E138E/A	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance L74I/M/I	1 Participants	0 Participants
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance E92E/V	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)

Population: PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.

The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log 10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log 10 c/mL unless \<400 c/mL or an increase of \>=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=17 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=7 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance <1 fold	3 Participants	0 Participants
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance 1-<2 fold	4 Participants	2 Participants
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance 4-<8 fold	1 Participants	2 Participants
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance 2-<4 fold	1 Participants	0 Participants
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance >=8 fold	8 Participants	3 Participants

SECONDARY outcome

Timeframe: From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II

Population: Safety Population: all participants that took at least one dose of DTG

Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyperglycaemia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypocalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypocalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypoglycaemia, Grade 4	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Magnesium, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Cholesterol,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatine Kinase,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Direct Bilirubin,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Direct Bilirubin,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Glucose,Grade 4	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities HDL Cholesterol direct,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Sodium,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Total Cholesterol/HDLratio, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Total Cholesterol/HDLratio, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Urea/BUN,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Urea/BUN,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypoglycaemia, Grade 3	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Carbon dioxide content/Bicarbonate, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatinine, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatinine Clearance, estimated, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatinine Clearance, estimated, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypercalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypercalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyperglycaemia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyperkalemia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyperkalemia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypernatremia, Grade 3	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypernatremia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypokalemia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hypokalemia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyponatremia, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Hyponatremia, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities LDL Cholesterol, Grade 3	2 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities LDL Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Magnesium, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Phosphorus inorganic, Grade 3	4 Participants	3 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Phosphorus inorganic, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Total Bilirubin, Grade 3	0 Participants	2 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Total Bilirubin, Grade 4	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Alanine Amino Transferase ,Grade 3	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Alanine Amino Transferase ,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Calcium,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Calcium,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Chloride,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Chloride,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Cholesterol,Grade 3	1 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Creatine Kinase,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Glucose,Grade 3	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities HDL Cholesterol direct,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Lipase,Grade 3	2 Participants	3 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Lipase,Grade 4	1 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Potassium,Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Potassium,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Sodium,Grade 3	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Triglycerides,Grade 3	0 Participants	2 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Triglycerides,Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Alkaline Phosphatase, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Alkaline Phosphatase, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Amylase, Grade 3	1 Participants	2 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Amylase, Grade 4	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Aspartate Amino Transferase, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Aspartate Amino Transferase, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities Carbon dioxide content/Bicarbonate, Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II

Population: Safety Population: all participants that took at least one dose of DTG

Outcome measures

Outcome measures
Measure	Cohort I (DTG 50 mg OD) n=27 Participants Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	Cohort II (DTG 50 mg BID) n=24 Participants Participants received DTG 50 mg twice a day (BID).
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Total Neutrophils, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities White Blood Cell count, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities White Blood Cell, Grade 4	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Hemoglobin, Grade 3	0 Participants	1 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Platelet count, Grade 3	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Platelet count, Grade 4	0 Participants	0 Participants
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities Total Neutrophils, Grade 4	0 Participants	2 Participants

Adverse Events

Cohort I (DTG 50 mg OD)

Serious events: 10 serious events

Other events: 25 other events

Deaths: 0 deaths

Cohort II (DTG 50 mg BID)

Serious events: 11 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER