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

A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00950859

Enrollment

Registered

2009-08-03

Start date

2009-08-31

Completion date

2015-01-31

Last updated

2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

Keywords

treatment experienced, HIV Infection, raltegravir resistance, GSK1349572, optimized background regimen, integrase inhibitor

Brief summary

Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying. GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.

Detailed description

Study (ING112961) is a Phase IIb, multicentre, open-label, single arm, two cohorts, pilot study to assess the antiviral activity of GSK1349572 containing regimen in HIV-1 infected ART-experienced adults with raltegravir (RAL) resistance. The study will include approximately 50 ART-experienced subjects with either current or past virologic failure to RAL. All subjects must harbour isolates with RAL resistance mutations at Screening. Subjects should also have documented genotypic and/or phenotypic resistance to at least one compound from each of three or more of the approved classes of ART (including integrase inhibitors \[INIs\]). Subjects with current RAL virologic failure will substitute RAL with GSK1349572 50mg once daily and continue the remaining components of their failing regimen through Day 10. Subjects with historical RAL virologic failure will add GSK1349572 50mg once daily to their failing regimen through Day 10. On Day 11 all subjects will continue GSK1349572 and optimize their background therapy. Antiviral activity, safety and tolerability of GSK1349572 will be evaluated at Day 11 and over time through at least Week 24. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Interventions

DRUGGSK1349572 (Cohort I)

50 mg once daily

DRUGGSK1349572 (Cohort II)

50 mg twice daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-1 infected male or female adults at least 18 years of age with a plasma HIV-1 RNA \> 1,000 copies/mL at study entry. Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol) * ART-experienced (defined as on stable ART for at least the last 2 months) and is either currently experiencing virologic failure to RAL or experienced virologic failure to RAL \> 8 weeks prior to Screening * Must have documented RAL genotypic resistance on study entry genotype * Must have documented genotypic or phenotypic resistance to at least one drug from each of three or more of all approved classes of ART * For Cohort II, Subjects MUST be able to receive at least one fully active drug as part of the Day 11 optimised background regimen * Willing and able to understand and provide signed and dated written informed consent prior to screening

Exclusion criteria

* Any pre-existing mental, physical, or substance abuse disorder which, which could compromise ability to comply with the protocol or compromise subject safety * Women who are pregnant or breastfeeding * An active AIDS-defining condition at the screening visit * Currently take and/or anticipated need for EFV, NVP, FPV/RTV or TPV/RTV during the study * Treatment with any of the following medications within 15 days of starting study drug, or anticipated to need, during the course of the study: Etravirine (unless co-administered with LPV/RTV or DRV/RTV), rifampin, rifabutin, phenytoin, phenobarbital, barbiturates, glucocorticoids, modafinil, oxcarbazepine, pioglitazone, troglitazone, carbamazepine, St. Johns wort * Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives * History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months * Expected to require treatment for HCV infection during the first 24 weeks of the study * Evidence of cirrhosis with or without hepatitis viral co-infection * History of upper gastrointestinal bleed and/or active peptic ulcer disease * Screening haemoglobin \<10g/dL (100g/L) * Subject suffers from a serious medical condition which could compromise the safety of the subject. * Any condition that could interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication * Screening lipase 3 times the upper limit of normal (ULN) * Any acute or Grade 4 laboratory abnormality at screening * Screening alanine aminotransferase (ALT) \>5xULN * Screening ALT 3xULN and bilirubin 1.5xULN (with 35% direct bilirubin) * Personal or family history of prolonged QT syndrome. * Any clinically significant finding, as specified in the protocol, on screening or baseline electrocardiograph (ECG) * History of allergy to the study drugs or their components or drugs of their class * Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or future need of treatment with these agents during the study * Treatment with immunomodulators within 28 days prior to screening or subject has received an HIV-1 vaccine within 90 days prior to screening

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
AUC0-24 Assessment of DTG	Day 10	AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Baseline; Weeks 4, 12, 24, 48, 72, and 96	The number of participants with plasma HIV-1 RNA \<400 c/mL or \<50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion	From Week 48 every 12 weeks up to study completion	The number of participants with plasma HIV-1 RNA \<400 c/mL or \<50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion	Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Cmax, Cmin, and Ctau of DTG	Day 10	The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
C0 Assessment of DTG	Day 10; Weeks 4 and 24	The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).
Tmax of DTG	Day 10	The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences	From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)	The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion	Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion	PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log10 c/mL unless \<400 c/mL or an increase of \>= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.
Number of Participants With the Indicated Genotypic Resistance at Baseline	Baseline	At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.
Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Baseline (Day 1)	Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.
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	From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)	An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log10 c/mL unless \<400 c/mL or an increase of \>= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.
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	From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)	The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of \<0.7 log 10 c/mL unless \<400 c/mL; at Weeks 8 to \<16, a decrease of \<1.0 log 10 c/mL unless \<400 c/mL or an increase of \>=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.
Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities	From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II	Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.
Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II	Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.
Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)	The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

Countries

Canada, France, Italy, Spain, United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).	27
Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID).	24
Total	51

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	3
Overall Study	Insufficient Viral Load Response	12	3
Overall Study	Lost to Follow-up	0	3
Overall Study	Protocol Violation	1	1

Baseline characteristics

Characteristic	Cohort I (DTG 50 mg OD)	Cohort II (DTG 50 mg BID)	Total
Age, Customized Years	48 Years	47 Years	47 Years
Race/Ethnicity, Customized African American/African Heritage	3 Participants	5 Participants	8 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	23 Participants	18 Participants	41 Participants
Sex: Female, Male Female	2 Participants	6 Participants	8 Participants
Sex: Female, Male Male	25 Participants	18 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	25 / 27	22 / 24
serious Total, serious adverse events	10 / 27	11 / 24

Outcome results

Primary

Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11

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

Time frame: Baseline (Day 1) and Day 11

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

Arm	Measure	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11	21 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11	23 Participants

95% CI: [58, 91]

95% CI: [79, 100]

Secondary

AUC0-24 Assessment of DTG

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

Time frame: Day 10

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Cohort I (DTG 50 mg OD)	AUC0-24 Assessment of DTG	36.46 Microgramshour per milliliter (µghr/mL	Geometric Coefficient of Variation 53
Cohort II (DTG 50 mg BID)	AUC0-24 Assessment of DTG	93.36 Microgramshour per milliliter (µghr/mL	Geometric Coefficient of Variation 50

Secondary

C0 Assessment of DTG

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

Time frame: Day 10; Weeks 4 and 24

Population: PK Parameter Population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort I (DTG 50 mg OD)	C0 Assessment of DTG	C0, Day 10	0.51 µg/mL	Geometric Coefficient of Variation 139
Cohort I (DTG 50 mg OD)	C0 Assessment of DTG	C0, Week 4	0.57 µg/mL	Geometric Coefficient of Variation 100
Cohort I (DTG 50 mg OD)	C0 Assessment of DTG	C0, Week 24	0.38 µg/mL	Geometric Coefficient of Variation 114
Cohort II (DTG 50 mg BID)	C0 Assessment of DTG	C0, Day 10	3.20 µg/mL	Geometric Coefficient of Variation 69
Cohort II (DTG 50 mg BID)	C0 Assessment of DTG	C0, Week 4	2.55 µg/mL	Geometric Coefficient of Variation 63
Cohort II (DTG 50 mg BID)	C0 Assessment of DTG	C0, Week 24	2.38 µg/mL	Geometric Coefficient of Variation 69

Secondary

Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion

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

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

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

Arm	Measure	Group	Value (MEDIAN)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 24, n=17, 22	78 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 108, n=13, 17	124 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 120, n=11, 17	221 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Day 11, n=27, 24	34 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 156, n=12, 15	212 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 144, n=12, 15	121 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 168, n=11, 13	97 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 4, n=27, 24	57 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 180, n=11, 10	125 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 132, n=11, 17	97 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 12, n= 22, 24	84 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 204, n=10, 6	92 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 192, n=10, 7	94 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 216, n=9, 6	172 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 48, n=15, 20	102 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 228, n=7, 3	148 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 264, n=1, 0	560 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 240, n=7, 0	158 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 72, n=14, 18	163 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 252, n=4, 0	157 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Baseline, n=27, 24	114 cells per cubic millimeter (mm^3)
Cohort I (DTG 50 mg OD)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 96, n=13, 15	142 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 264, n=1, 0	NA cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 108, n=13, 17	155 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 144, n=12, 15	278 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 156, n=12, 15	223 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Baseline, n=27, 24	202 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Day 11, n=27, 24	14 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 4, n=27, 24	35 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 24, n=17, 22	79 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 48, n=15, 20	106 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 72, n=14, 18	191.5 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 96, n=13, 15	189 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 120, n=11, 17	221 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 132, n=11, 17	158 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 168, n=11, 13	271 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 180, n=11, 10	224 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 192, n=10, 7	343 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 204, n=10, 6	264 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 216, n=9, 6	252 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 228, n=7, 3	417 cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 240, n=7, 0	NA cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 252, n=4, 0	NA cells per cubic millimeter (mm^3)
Cohort II (DTG 50 mg BID)	Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion	Week 12, n= 22, 24	57 cells per cubic millimeter (mm^3)

Secondary

Cmax, Cmin, and Ctau of DTG

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

Time frame: Day 10

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort I (DTG 50 mg OD)	Cmax, Cmin, and Ctau of DTG	Cmin	0.48 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 136
Cohort I (DTG 50 mg OD)	Cmax, Cmin, and Ctau of DTG	Cmax	3.04 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 38
Cohort I (DTG 50 mg OD)	Cmax, Cmin, and Ctau of DTG	Ctau	0.69 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 91
Cohort II (DTG 50 mg BID)	Cmax, Cmin, and Ctau of DTG	Cmax	5.41 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 40
Cohort II (DTG 50 mg BID)	Cmax, Cmin, and Ctau of DTG	Ctau	2.72 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 70
Cohort II (DTG 50 mg BID)	Cmax, Cmin, and Ctau of DTG	Cmin	2.61 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 67

Secondary

Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion

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

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 264, n= 1, 0	-2.90 Log10 copies/mL	—
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 192, n= 9, 7	-1.87 Log10 copies/mL	Standard Deviation 1.16
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 228, n= 6, 4	-1.79 Log10 copies/mL	Standard Deviation 1.08
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 240, n= 7, 0	-1.63 Log10 copies/mL	Standard Deviation 1.13
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Day 6 to 8, n=27, 24	-1.31 Log10 copies/mL	Standard Deviation 0.71
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Day 11, n=27, 24	-1.45 Log10 copies/mL	Standard Deviation 0.77
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 4, n=26, 24	-1.82 Log10 copies/mL	Standard Deviation 1.03
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 12, n=22, 24	-1.94 Log10 copies/mL	Standard Deviation 1.14
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 24, n=18, 22	-1.99 Log10 copies/mL	Standard Deviation 1.08
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 48, n=15, 20	-2.02 Log10 copies/mL	Standard Deviation 1.07
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 72, n=14, 18	-2.10 Log10 copies/mL	Standard Deviation 1.03
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 108, n= 13, 17	-1.95 Log10 copies/mL	Standard Deviation 1.2
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 120, n= 11, 17	-2.09 Log10 copies/mL	Standard Deviation 1.15
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 132, n= 11, 17	-1.83 Log10 copies/mL	Standard Deviation 1.01
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 144, n= 12, 15	-2.08 Log10 copies/mL	Standard Deviation 1.29
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 156, n= 12, 15	-2.04 Log10 copies/mL	Standard Deviation 1.36
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 168, n= 11, 14	-1.77 Log10 copies/mL	Standard Deviation 1.26
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 180, n= 11, 10	-1.76 Log10 copies/mL	Standard Deviation 1.11
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 204, n= 10, 6	-1.76 Log10 copies/mL	Standard Deviation 1.21
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 216, n= 9, 6	-1.61 Log10 copies/mL	Standard Deviation 1.08
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 252, n= 4, 0	-1.72 Log10 copies/mL	Standard Deviation 1.07
Cohort I (DTG 50 mg OD)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 96, n=13, 15	-2.06 Log10 copies/mL	Standard Deviation 1.13
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 144, n= 12, 15	-2.62 Log10 copies/mL	Standard Deviation 0.94
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 180, n= 11, 10	-2.56 Log10 copies/mL	Standard Deviation 0.82
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 72, n=14, 18	-2.71 Log10 copies/mL	Standard Deviation 0.82
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 192, n= 9, 7	-2.51 Log10 copies/mL	Standard Deviation 0.98
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 216, n= 9, 6	-2.35 Log10 copies/mL	Standard Deviation 0.71
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 96, n=13, 15	-2.58 Log10 copies/mL	Standard Deviation 0.77
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 228, n= 6, 4	-2.33 Log10 copies/mL	Standard Deviation 0.9
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 204, n= 10, 6	-2.35 Log10 copies/mL	Standard Deviation 0.71
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 252, n= 4, 0	NA Log10 copies/mL	—
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 264, n= 1, 0	NA Log10 copies/mL	—
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 108, n= 13, 17	-2.69 Log10 copies/mL	Standard Deviation 0.82
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Day 6 to 8, n=27, 24	-1.40 Log10 copies/mL	Standard Deviation 0.43
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 156, n= 12, 15	-2.65 Log10 copies/mL	Standard Deviation 0.77
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Day 11, n=27, 24	-1.76 Log10 copies/mL	Standard Deviation 0.53
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 120, n= 11, 17	-2.67 Log10 copies/mL	Standard Deviation 0.85
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 4, n=26, 24	-2.06 Log10 copies/mL	Standard Deviation 0.78
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 240, n= 7, 0	NA Log10 copies/mL	—
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 12, n=22, 24	-2.30 Log10 copies/mL	Standard Deviation 0.93
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 132, n= 11, 17	-2.66 Log10 copies/mL	Standard Deviation 0.86
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 24, n=18, 22	-2.50 Log10 copies/mL	Standard Deviation 0.81
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 168, n= 11, 14	-2.72 Log10 copies/mL	Standard Deviation 0.89
Cohort II (DTG 50 mg BID)	Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion	Week 48, n=15, 20	-2.63 Log10 copies/mL	Standard Deviation 0.78

Secondary

Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group

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

Time frame: Baseline (Day 1)

Population: ITT-E Population

Arm	Measure	Group	Value (MEDIAN)
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Q148 + 1, n=4, 8	5.5 Percentage
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Y143, n=12, 6	1.1 Percentage
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Q148 + 2, n=3, 2	21 Percentage
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	N155, n=4, 6	1.8 Percentage
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Mixture, n=2, 1	7.8 Percentage
Cohort I (DTG 50 mg OD)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Other, n=2, 1	1.2 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Mixture, n=2, 1	9.48 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Q148 + 2, n=3, 2	4 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Q148 + 1, n=4, 8	5.5 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Other, n=2, 1	0.87 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	Y143, n=12, 6	1.2 Percentage
Cohort II (DTG 50 mg BID)	Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group	N155, n=4, 6	2.3 Percentage

Secondary

Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion

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

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

Population: ITT-E Population

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 192	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Day 11	6 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 8	7 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 12	9 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 16	10 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 20	10 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 24	12 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 32	12 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 40	12 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 48	13 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 60	13 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 72	14 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 84	15 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 96	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 108	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 120	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 132	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 144	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 156	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 168	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 180	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 204	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 216	17 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 228	18 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 240	18 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 252	18 Participants
Cohort I (DTG 50 mg OD)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 264	18 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Day 11	1 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 228	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 108	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 192	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 8	3 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 120	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 12	3 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 252	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 16	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 132	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 20	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 204	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 24	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 144	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 32	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 240	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 40	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 156	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 48	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 216	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 60	5 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 168	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 72	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 264	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 84	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 180	7 Participants
Cohort II (DTG 50 mg BID)	Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion	Week 96	6 Participants

Secondary

Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.

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

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

Population: ITT-E Population

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Baseline, <50 c/mL	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 96, <50 c/mL	7 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 48, <50 c/mL	9 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Baseline, <400 c/mL	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 24, <400 c/mL	14 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 4, <400 c/mL	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 12, <50 c/mL	13 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 12, <400 c/mL	16 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 48, <400 c/mL	13 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 24, <50 c/mL	11 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 72, <400 c/mL	12 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 72, <50 c/mL	8 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 96, <400 c/mL	10 Participants
Cohort I (DTG 50 mg OD)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 4, <50 c/mL	9 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 96, <400 c/mL	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 48, <50 c/mL	17 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Baseline, <50 c/mL	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 4, <50 c/mL	12 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 12, <50 c/mL	16 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 24, <50 c/mL	19 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 72, <50 c/mL	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 96, <50 c/mL	NA Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Baseline, <400 c/mL	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 4, <400 c/mL	17 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 12, <400 c/mL	20 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 24, <400 c/mL	20 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 48, <400 c/mL	18 Participants
Cohort II (DTG 50 mg BID)	Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.	Week 72, <400 c/mL	NA Participants

Secondary

Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death

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

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

Population: ITT-E Population.

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class C to new CDC class C	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class A to CDC class C	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC Class A, B, or C to death	3 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class B to CDC class C	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC Class A, B, or C to death	2 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class A to CDC class C	2 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class C to new CDC class C	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death	From CDC class B to CDC class C	2 Participants

Secondary

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

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

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

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

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance	1-<2 fold	4 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance	4-<8 fold	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance	2-<4 fold	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance	>=8 fold	8 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance	<1 fold	3 Participants
Cohort II (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	>=8 fold	3 Participants
Cohort II (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	0 Participants
Cohort II (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-<2 fold	2 Participants
Cohort II (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	2-<4 fold	0 Participants
Cohort II (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	4-<8 fold	2 Participants

Secondary

Number of Participants With the Indicated Genotypic Resistance at Baseline

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

Time frame: Baseline

Population: ITT-E Population

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Q 148 + 1	4 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Y143	12 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Q148 + 2	3 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	N155	4 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Mixture	2 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Other	2 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Mixture	1 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Q148 + 2	2 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Q 148 + 1	8 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Other	1 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	Y143	6 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Genotypic Resistance at Baseline	N155	6 Participants

Secondary

Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities

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

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

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

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

Secondary

Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities

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

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

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Hemoglobin, Grade 3	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Hemoglobin, Grade 4	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Platelet count, Grade 3	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Platelet count, Grade 4	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Total Neutrophils, Grade 3	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Total Neutrophils, Grade 4	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	White Blood Cell count, Grade 3	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	White Blood Cell, Grade 4	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	White Blood Cell, Grade 4	1 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Total Neutrophils, Grade 3	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	White Blood Cell count, Grade 3	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Hemoglobin, Grade 3	1 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Hemoglobin, Grade 4	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Platelet count, Grade 3	0 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Total Neutrophils, Grade 4	2 Participants
Cohort II (DTG 50 mg BID)	Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities	Platelet count, Grade 4	0 Participants

Secondary

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences

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

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

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

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

Secondary

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

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

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

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

Arm	Measure	Group	Value (NUMBER)
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	Any	11 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	L68L/I	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	E138T	0 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	N155H	3 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	T97A	2 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	E92E/Q	0 Participants
Cohort I (DTG 50 mg OD)	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
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	L74I/M	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	Q148H	2 Participants
Cohort I (DTG 50 mg OD)	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
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	E138E/K	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	L74I/M/I	1 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	L74M	1 Participants
Cohort I (DTG 50 mg OD)	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
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	T97T/A	0 Participants
Cohort I (DTG 50 mg OD)	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
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	S147G	3 Participants
Cohort I (DTG 50 mg OD)	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance	E92E/V	0 Participants
Cohort II (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	L74I	0 Participants
Cohort II (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	G140S	0 Participants
Cohort II (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	E92E/V	1 Participants
Cohort II (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	E138E/A	0 Participants
Cohort II (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	5 Participants
Cohort II (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	L68L/I	0 Participants
Cohort II (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	E138T	1 Participants
Cohort II (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	E138E/K	2 Participants
Cohort II (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	N155H	4 Participants
Cohort II (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	T97T/A	2 Participants
Cohort II (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	T97A	0 Participants
Cohort II (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	L74I/M/I	0 Participants
Cohort II (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	E92E/Q	1 Participants
Cohort II (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	S147G	0 Participants
Cohort II (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	L74M	0 Participants
Cohort II (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	L74I/M	0 Participants
Cohort II (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	Q148R	0 Participants
Cohort II (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	Q148H	0 Participants

Secondary

Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion

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

Time frame: From Week 48 every 12 weeks up to study completion

Population: ITT-E Population

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

Secondary

Tmax of DTG

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

Time frame: Day 10

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Cohort I (DTG 50 mg OD)	Tmax of DTG	2.97 Hours
Cohort II (DTG 50 mg BID)	Tmax of DTG	2.00 Hours

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026

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

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Secondary

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Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11

AUC0-24 Assessment of DTG

C0 Assessment of DTG

Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion

Cmax, Cmin, and Ctau of DTG

Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion

Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group

Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion

Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.

Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death

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

Number of Participants With the Indicated Genotypic Resistance at Baseline

Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities

Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences

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

Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion

Tmax of DTG