Trial Outcomes & Findings for A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (NCT NCT01328041)

Last Updated: 2016-01-07

Results Overview

Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

183 participants

Primary outcome timeframe

Baseline and Day 8

Results posted on

2016-01-07

Participant Flow

Participants (par.) having documented Human immunodeficiency virus type 1 (HIV-1) infection with a plasma HIV-1 Ribonucleic acid(RNA) \>=500 copies per milliliter (c/mL) at Screening, Antiretroviral therapy (ART)-experienced and on stable ART for at least one month prior to Screening were enrolled

A total of 139 par. were screen failures and 183 par. entered the single arm, open-label study.

Participant milestones

Participant milestones
Measure	Dolutegravir 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
Overall Study STARTED	183
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Dolutegravir 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	27
Overall Study Protocol Violation	7
Overall Study Lost to Follow-up	7
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	7

Baseline Characteristics

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Age, Continuous	48 Years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	49 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native and White	1 participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	1 participants n=5 Participants
Race/Ethnicity, Customized White	130 participants n=5 Participants
Race/Ethnicity, Customized White and African American/African Heritage	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 8

Population: Intent-to-Treat-Exposed (ITT-E) Population: all participants who received at least one dose of study drug. Only participants who had Day 8 observations were considered for analysis.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=182 Participants Participants received DTG 50 mg BID.
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8	-1.432 log10 copies/milliliter (mL) Standard Deviation 0.6070

PRIMARY outcome

Timeframe: Week 24

Population: ITT-E Population

The number of participants who had viral load \<50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI \[due to missing data/discontinuation of investigational product prior to the visit window\]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24	126 participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population

The number of participants who had viral load \<50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI \[due to missing data/discontinuation of investigational product prior to the visit window\]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48	116 participants

PRIMARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: Safety Population: all participants who received at least one dose of study drug

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any AE	169 participants
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any SAE	46 participants

PRIMARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: Safety Population

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale Grade 1	45 participants
Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale Grade 2	64 participants
Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale Grade 3	44 participants
Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale Grade 4	16 participants

PRIMARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: Safety Population

The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade Grade 1	49 participants
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade Grade 2	67 participants
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade Grade 3	43 participants
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade Grade 4	16 participants

PRIMARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: Safety Population

The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade Grade 1	31 Participants
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade Grade 2	15 Participants
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade Grade 3	4 Participants
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade Grade 4	2 Participants

SECONDARY outcome

Timeframe: Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Population: ITT-E Population

The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI \[due to missing data/discontinuation of investigational product prior to the visit window\]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Baseline	1 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Day 8	28 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 4	98 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 8	112 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 12	116 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 16	116 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 24	126 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 32	117 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 40	108 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <50 c/mL, Week 48	116 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Baseline	8 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Day 8	82 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 4	145 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 8	146 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 12	142 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 16	139 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 24	135 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 32	127 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 40	119 participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 HIV-1 RNA <400 c/mL, Week 48	125 participants

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 less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 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	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 48, n =146	121 Participants Interval 40.0 to 330.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 60, n=142	110 Participants Interval 60.0 to 350.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 72, n=138	116 Participants Interval 80.0 to 350.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 84, n=138	108 Participants Interval 100.0 to 350.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 96, n=120	101 Participants Interval 110.0 to 360.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 108, n=98	81 Participants Interval 130.0 to 400.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 120, n=82	72 Participants Interval 130.0 to 420.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 132, n=61	49 Participants Interval 170.0 to 440.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 144, n=45	37 Participants Interval 200.0 to 440.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 156, n=32	28 Participants Interval 200.0 to 450.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 168, n=24	20 Participants Interval 540.0 to 1220.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <50 c/mL, Week 180, n=6	4 Participants Interval 655.0 to 1405.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 48, n=146	134 Participants Interval 730.0 to 1460.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 60, n=142	131 Participants Interval 690.0 to 1460.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 72, n=138	130 Participants Interval 720.0 to 1380.0
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 84, n=138	127 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 96, n=120	111 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 108, n=98	92 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 120, n=82	80 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 132, n=61	59 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 144, n=45	44 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 156, n=32	31 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 168, n=24	23 Participants
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion HIV-1 RNA <400 c/mL, Week 180, n=6	5 Participants

SECONDARY outcome

Timeframe: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)

Population: ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.

Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Day 8, n=182	-1.432 Log10 copies/mL Standard Deviation 0.607 • Interval 0.0 to 60.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 4, n=180	-2.088 Log10 copies/mL Standard Deviation 0.885 • Interval 0.0 to 71.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 8, n=179	-2.101 Log10 copies/mL Standard Deviation 0.987 • Interval 0.0 to 81.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 12, n=174	-2.113 Log10 copies/mL Standard Deviation 1.069 • Interval 0.0 to 100.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 16, n=165	-2.216 Log10 copies/mL Standard Deviation 1.005 • Interval 20.0 to 130.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 24, n=164	-2.211 Log10 copies/mL Standard Deviation 1.023 • Interval 20.0 to 130.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 32, n=146	-2.373 Log10 copies/mL Standard Deviation 0.926 • Interval 20.0 to 160.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 40, n=144	-2.301 Log10 copies/mL Standard Deviation 0.955 • Interval 30.0 to 180.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 48, n=146	-2.321 Log10 copies/mL Standard Deviation 0.981 • Interval 40.0 to 190.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 60, n=142	-2.356 Log10 copies/mL Standard Deviation 0.928 • Interval 50.0 to 210.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 72, n=138	-2.390 Log10 copies/mL Standard Deviation 0.941
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 84, n=138	-2.311 Log10 copies/mL Standard Deviation 0.996 • Interval 80.0 to 240.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 96, n=120	-2.346 Log10 copies/mL Standard Deviation 1.008 • Interval 80.0 to 270.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 108, n=98	-2.394 Log10 copies/mL Standard Deviation 0.966 • Interval 80.0 to 280.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 120, n=82	-2.515 Log10 copies/mL Standard Deviation 0.904 • Interval 100.0 to 280.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 132, n=61	-2.456 Log10 copies/mL Standard Deviation 0.988 • Interval 100.0 to 320.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 144, n=45	-2.585 Log10 copies/mL Standard Deviation 0.983 • Interval 130.0 to 350.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 156, n=32	-2.595 Log10 copies/mL Standard Deviation 1.009 • Interval 155.0 to 345.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 168, n=24	-2.719 Log10 copies/mL Standard Deviation 0.898 • Interval 155.0 to 380.0
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion Week 180, n=6	-2.425 Log10 copies/mL Standard Deviation 1.557 • Interval 140.0 to 230.0

SECONDARY outcome

Timeframe: Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Baseline, n=183	140.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.607 • Interval 40.0 to 330.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Day 8, n=181	170.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.885 • Interval 60.0 to 350.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 4, n=178	185.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.987 • Interval 80.0 to 350.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 8, n=178	210.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 1.069 • Interval 100.0 to 350.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 12, n=171	210.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 1.005 • Interval 110.0 to 360.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 16, n=165	210.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 1.023 • Interval 130.0 to 400.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 24, n=163	250.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.926 • Interval 130.0 to 420.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 32, n=147	270.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.955 • Interval 170.0 to 440.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 40, n=143	290.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.981 • Interval 200.0 to 440.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD4+, Week 48, n=145	310.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.928 • Interval 200.0 to 450.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD8+, Week 4, n=181	860.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.941 • Interval 540.0 to 1220.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD8+, Week 4, n=176	970.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.996 • Interval 655.0 to 1405.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD8+, Week 12, n=170	1015.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 1.008 • Interval 730.0 to 1460.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD8+, Week 24, n=154	1020.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.966 • Interval 690.0 to 1460.0
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48 CD8+, Week 48, n=140	1000.0 Cells per millimeters cubed (cells/mm^3) Inter-Quartile Range 0.904 • Interval 720.0 to 1380.0

SECONDARY outcome

Timeframe: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v

Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Day 8, n=181	20.0 Cells per millimeters cubed (cells/mm^3) Interval 0.0 to 60.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 4, n=178	30.0 Cells per millimeters cubed (cells/mm^3) Interval 0.0 to 71.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 8, n=178	40.0 Cells per millimeters cubed (cells/mm^3) Interval 0.0 to 81.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 12, n=171	50.0 Cells per millimeters cubed (cells/mm^3) Interval 0.0 to 100.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 16, n=165	60.0 Cells per millimeters cubed (cells/mm^3) Interval 20.0 to 130.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 24, n=163	61.0 Cells per millimeters cubed (cells/mm^3) Interval 20.0 to 130.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 32, n=147	100.0 Cells per millimeters cubed (cells/mm^3) Interval 20.0 to 160.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 40, n=143	90.0 Cells per millimeters cubed (cells/mm^3) Interval 30.0 to 180.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 48, n=145	110.0 Cells per millimeters cubed (cells/mm^3) Interval 40.0 to 190.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 60, n=142	120.0 Cells per millimeters cubed (cells/mm^3) Interval 50.0 to 210.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 72, n=138	140.0 Cells per millimeters cubed (cells/mm^3) Interval 60.0 to 231.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 84, n=137	150.0 Cells per millimeters cubed (cells/mm^3) Interval 80.0 to 240.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 96, n=117	160.0 Cells per millimeters cubed (cells/mm^3) Interval 80.0 to 270.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 108, n=98	180.5 Cells per millimeters cubed (cells/mm^3) Interval 80.0 to 280.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 120, n=82	180.0 Cells per millimeters cubed (cells/mm^3) Interval 100.0 to 280.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 132, n=61	221.0 Cells per millimeters cubed (cells/mm^3) Interval 100.0 to 320.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 144, n=46	205.0 Cells per millimeters cubed (cells/mm^3) Interval 130.0 to 350.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week 156, n=32	225.0 Cells per millimeters cubed (cells/mm^3) Interval to 345.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week168, n=24	265.0 Cells per millimeters cubed (cells/mm^3) Interval 155.0 to 380.0
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion CD4+, Week180, n=6	170.5 Cells per millimeters cubed (cells/mm^3) Interval 140.0 to 230.0

SECONDARY outcome

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

The ratio of CD4+/CD8+ cell count (measured in cells/mm\^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 Baseline, n=180	0.15 ratio Interval 0.05 to 0.34
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 Week 4, n=176	0.19 ratio Interval 0.09 to 0.37
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 Week 12, n=170	0.21 ratio Interval 0.1 to 0.46
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 Week 24, n=154	0.26 ratio Interval 0.14 to 0.46
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48 Week 48, n=140	0.32 ratio Interval 0.19 to 0.52

SECONDARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: ITT-E Population

The number of participants with HIV-1 disease progression (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	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death) Progression from CDC Class A to Class C Event	1 Participants Interval 4.18 to 5.36
Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death) Progression from CDC Class B to Class C Event	2 Participants Interval 2.15 to 3.15
Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death) Progression from CDC Class C to New Class C Event	6 Participants
Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death) Progression from Classes A, B, or C to Death	2 Participants

SECONDARY outcome

Timeframe: Day 8, Week 4, and Week 24

Population: The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.

The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
Cmax and Ctau of DTG Cmax	4.74 Micrograms per milliliter (µg/mL) Interval 4.18 to 5.36
Cmax and Ctau of DTG Ctau	2.60 Micrograms per milliliter (µg/mL) Interval 2.15 to 3.15

SECONDARY outcome

Timeframe: Day 8, Week 4, and Week 24

Population: The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.

The area under the time concentration curve over the dosing interval (AUC\[0-tau\]) and from 0 to 24 hours (AUC\[0-24\]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=183 Participants Participants received DTG 50 mg BID.
AUC(0-tau) and AUC(0-24) of DTG AUC(0-tau)	36.7 µg*hour/mL 95% Confidence Interval 91 • Interval 35.0 to 38.6
AUC(0-tau) and AUC(0-24) of DTG AUC(0-24)	73.5 µg*hour/mL 95% Confidence Interval 113 • Interval 70.0 to 77.1

SECONDARY outcome

Timeframe: Day 8, Week 4, and Week 24

Population: Pharmacokinetic (PK) Parameter Population: all participants who received DTG, underwent PK sampling during the study, and provided an evaluable estimate of C0. Only participants with data available at the indicated time points were considered for analysis.

The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=161 Participants Participants received DTG 50 mg BID.
C0 Assessment of DTG Day 8, n=148	2.36 µg/mL Geometric Coefficient of Variation 91
C0 Assessment of DTG Week 4, n=161	1.90 µg/mL Geometric Coefficient of Variation 113
C0 Assessment of DTG Week 24, n=135	2.14 µg/mL Geometric Coefficient of Variation 93

SECONDARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: PDVF Genotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF. Only participants with Baseline IN mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.

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 a \<0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is \<400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of \<1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA \<400 c/mL and confirmed plasma HIV-1 RNA levels \>=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to \>=400 c/mL after prior confirmed suppression to \<400 c/mL and confirmed plasma HIV-1 RNA levels \>1 log10 c/mL above the nadir value \[nadir: \>=400 c/mL\]).

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=42 Participants Participants received DTG 50 mg 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 IN mutation	25 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	8 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	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 E138A	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 E138E/A	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 E138E/K	3 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 E138K	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 E138T/A	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	6 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 N155N/H	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 Q148H	3 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 Q148Q/H	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
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 Q148Q/R/K	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 G140G/S	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
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 L74L/M/V	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 L74L/M	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 L74I	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 E92E/Q	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 S147G	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 E157E/Q	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 V151V/M/I	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 Y143Y/H	1 participants

SECONDARY outcome

Timeframe: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Population: PDVF Phenotypic Resistance Populations. Only participants with Baseline DTG IC50 with PDVF who had paired Baseline and time of virological failure samples 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 as a \<0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is \<400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA \<400 copies/mL and confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL and confirmed plasma HIV-1 RNA levels \>1 log10 copies/mL above the nadir value, where nadir is \>=400 copies/mL).

Outcome measures

Outcome measures
Measure	Dolutegravir 50 mg BID n=45 Participants Participants received DTG 50 mg 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	6 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	16 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	4 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	4 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	12 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 Missing	3 Participants

Adverse Events

Dolutegravir 50 mg BID

Serious events: 46 serious events

Other events: 143 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dolutegravir 50 mg BID n=183 participants at risk Participants received DTG 50 mg BID.
Infections and infestations Pneumonia	2.7% 5/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Progressive multifocal leukoencephalopathy	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
General disorders Pyrexia	1.6% 3/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Dehydration	1.6% 3/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Cytomegalovirus infection	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Cytomegalovirus viraemia	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Epstein-Barr virus infection	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Gastroenteritis viral	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Herpes ophthalmic	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Herpes zoster	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Lung infection	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Oesophageal candidiasis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Pneumococcal sepsis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Septic shock	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Streptococcal sepsis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Viral infection	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Cholecystitis acute	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Cholelithiasis	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hepatic cirrhosis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hepatitis acute	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hyperbilirubinaemia	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Cerebrovascular accident	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Convulsion	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Nerve compression	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Dysphagia	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Parotid gland enlargement	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Productive cough	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Cardiac disorders Cardiac failure congestive	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Renal and urinary disorders Renal failure	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Drug eruption	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Immune system disorders Immune reconstitution inflammatory syndrome	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Investigations Alanine aminotransferase increased	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Reproductive system and breast disorders Ovarian mass	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Vascular disorders Hypertensive emergency	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Eye infection toxoplasmal	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Gastroenteritis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Herpes virus infection	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Bile duct obstruction	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Drug-induced liver injury	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastritis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Haematochezia	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Rectal haemorrhage	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease recurrent	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Syncope	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Transient ischaemic attack	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.1% 2/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Cardiac disorders Angina pectoris	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Cardiac disorders Coronary artery disease	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Psychiatric disorders Bipolar disorder	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Psychiatric disorders Depression	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Tendonitis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Hepatitis B	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Oral candidiasis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Orchitis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer stage I	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer stage 0	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Aphthous stomatitis	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hepatocellular injury	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Nodular regenerative hyperplasia	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Seizure	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash generalised	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Joint destruction	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Renal and urinary disorders Acute kidney injury	0.55% 1/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.

Other adverse events

Other adverse events
Measure	Dolutegravir 50 mg BID n=183 participants at risk Participants received DTG 50 mg BID.
General disorders Fatigue	9.3% 17/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
General disorders Pyrexia	10.4% 19/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
General disorders Asthenia	7.1% 13/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
General disorders Injection site reaction	6.6% 12/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	22.4% 41/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	14.2% 26/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Bronchitis	13.7% 25/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Upper respiratory tract infection	12.0% 22/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Nasopharyngitis	6.6% 12/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Rhinitis	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	9.8% 18/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 12/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Nervous system disorders Headache	13.1% 24/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	15.8% 29/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	9.3% 17/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Psychiatric disorders Insomnia	7.7% 14/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	7.1% 13/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain upper	7.7% 14/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	6.6% 12/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Influenza	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Infections and infestations Sinusitis	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.5% 10/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Psychiatric disorders Anxiety	5.5% 10/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.
Vascular disorders Hypertension	6.0% 11/183 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treament until the end of treatment visit for each participant (up to Week 180) On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of investigational product.

Additional Information

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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.
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