Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir

A Phase III Randomized, Double-blind Study to Demonstrate the Antiviral Activity of Dolutegravir (DTG) 50 mg Twice Daily Versus Placebo Both Co-Administered With a Failing Antiretroviral Regimen Over Seven Days, Followed by an Open Label Phase With All Subjects Receiving DTG 50 mg Twice Daily Co-administered With an Optimised Background Regimen (OBR) in HIV-1 Infected, Integrase Inhibitor Therapy-Experienced and Resistant, Adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01568892

Acronym

VIKING-4

Enrollment

Registered

2012-04-02

Start date

2012-04-18

Completion date

2013-12-16

Last updated

2018-07-02

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

Conditions

HIV Infections

Keywords

ART-experienced, GSK1349572, Integrase inhibitor resistance, Dolutegravir

Brief summary

Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo- controlled, functional monotherapy phase to quantify the antiviral activity attributable to dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug.

Detailed description

Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-controlled, functional monotherapy phase to assess the antiviral activity and safety of a dolutegravir (DTG, GSK1349572) containing regimen in HIV-1 infected, ART-experienced adults with virological failure on an integrase inhibitor (INI) containing regimen. Subjects must have evidence of genotypic resistance to raltegravir \[RAL\] or elvitegravir \[ELV\] at Screening and documented current or historical genotypic or phenotypic resistance to at least two other antiretroviral therapy drug classes. The study is designed to provide an accurate measure of the intrinsic antiviral activity of DTG 50mg twice daily versus placebo both administered with the current failing regimen in a randomised double-blind phase to Day 8. This will be followed by an open label phase with all subjects receiving DTG 50mg twice daily with an optimized background regimen (containing at least one fully active drug) until subjects no longer derive clinical benefit or until DTG is locally available. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing at Day 1). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug The primary analysis will be conducted after the last subject enrolled has completed the randomised, double-blind phase at Day 8. Additional analyses may be performed prior to study closure when all ongoing subjects transition to locally available commercial DTG.

Interventions

DRUGDolutegravir 50 mg twice daily

Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8)

DRUGDolutegravir placebo twice daily

Dolutegravir placebo plus failing background regimen (Day 1 to Day 7)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Screening plasma HIV-1 RNA ≥1000 copies/mL * ART-experienced, INI-experienced, DTG naïve * Current virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen * The subject's HIV-1 shows genotypic resistance to RAL or ELV at Screening * Subject has been on stable ART for at least one month prior to Screening and through Day 1(with exceptions for ETV, EFV and NVP that can be interrupted within 14 days of Day 1, see Exclusion Criterion) * Documented resistance to at least one drug from each of two or more of any approved classes of ART other than integrase inhibitors * Be able to receive at least one fully active drug as part of the OBR from Day 8 * Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol) * Willing and able to understand and provide signed and dated written informed consent prior to Screening.

Exclusion criteria

* Women who are pregnant or breast feeding * An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ \<200c/mm3) * Moderate to severe hepatic impairment as defined by Child-Pugh classification * Anticipated need for HCV therapy during the first 24 weeks of the study * Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding * Allergy or intolerance to the study drugs or their components or drugs of their class * Malignancy within the past 6 months * Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening * Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening * Treatment with any agent, other than licensed ART, with documented in vitro/vivo activity against HIV-1 within 28 days of first dose of investigational product (with the exception of entecavir if required for Hep B treatment) * Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinavir/ritonavir or darunavir/ritonavir) * Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening * Exposure to an experimental drug or vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, which ever is longer, prior to the first dose of IP. * Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening * ALT\> 5 times the upper limit of normal (ULN) at Screening * ALT ≥ 3X ULN and bilirubin \> 1.5 X ULN (with 35% direct bilirubin) at Screening

Design outcomes

Primary

Measure	Time frame	Description
Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8	Baseline and Day 8	Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.

Secondary

Measure	Time frame	Description
Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84	Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48	Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level \<50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.
Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48	Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level \<400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.
Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84	Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.
Median Change From Baseline in CD4+ Cell Counts Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84	Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Baseline; Day 28; Weeks 12, 24, and 48	Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.
Median Change From Baseline in CD8+ Cell Counts Over Time	Baseline; Day 28; Weeks 12, 24, and 48	Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)	The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
AUC(0-tau) of DTG	Day 8, Day 28, and Week 24	The area under the time concentration curve over the dosing interval (AUC\[0-tau\]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.
Cmax of DTG	Day 8, Day 28, and Week 24	The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.
Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Day 8, Day 28, and Week 24	Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>1 log10 copies/mL above the nadir value, where nadir is \>=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.
Absolute Values in Plasma HIV-1 RNA Over Time	Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84	Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.
Number of Participants Who Discontinued Study Treatment Due to AEs	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	The number of participants who permanently discontinued study treatment due to AEs is presented.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings	Up to Week 24	Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline and Weeks 24 and 48	Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Change From Baseline in Heart Rate	Baseline and Weeks 24 and 48	Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Change From Baseline in Albumin Level	Baseline, Week 24 and 48	Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Creatinine Clearance	Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48	Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Change From Baseline in Lipase Levels	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Hemoglobin Level	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Hematocrit Level	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Mean Corpuscle Volume	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Change From Baseline in Red Blood Cell Count	Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84	Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance	From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)	For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of 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 was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>1 log10 copies/mL above the nadir value, where nadir is \>=400 copies/mL.

Countries

United States

Participant flow

Pre-assignment details

Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.

Participants by arm

Arm	Count
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.	14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.	16
Total	30

Withdrawals & dropouts

Period	Reason	FG000	FG001
Open-label Phase	Adverse Event	2	0
Open-label Phase	Lack of Efficacy	4	2
Open-label Phase	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Total	DTG 50 mg BID
Age, Continuous	48.6 Years STANDARD_DEVIATION 8.85	48.1 Years STANDARD_DEVIATION 10.04	47.5 Years STANDARD_DEVIATION 11.56
Race/Ethnicity, Customized African American/African Heritage	8 Participants	16 Participants	8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Missing: None of the Available Races Applied	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	7 Participants	11 Participants	4 Participants
Sex: Female, Male Female	4 Participants	6 Participants	2 Participants
Sex: Female, Male Male	12 Participants	24 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 14	0 / 16
other Total, other adverse events	11 / 14	14 / 16
serious Total, serious adverse events	5 / 14	4 / 16

Outcome results

Primary

Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8

Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.

Time frame: Baseline and Day 8

Population: ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
DTG 50 mg BID	Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8	-1.06 Log 10 copies per milliliter (c/mL)	Standard Error 0.168
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8	0.10 Log 10 copies per milliliter (c/mL)	Standard Error 0.183

p-value: <0.00195% CI: [-1.52, -0.8]ANCOVA

Secondary

Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time

Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84

Population: ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEDIAN)
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 32, n=11, 14	213.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 40, n=8, 12	299.5 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 48, n=8, 13	328.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 60, n=5, 12	321.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 72, n=3, 4	321.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Day 8, n=14, 15	198.5 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Day 28, n=13, 16	174.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 8, n=11, 16	211.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 12, n=12, 14	223.5 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 16, n=12, 16	241.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 24, n=11, 15	232.0 Cells per cubic millimeters
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Baseline, n=14, 16	163.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 16, n=12, 16	262.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Day 8, n=14, 15	102.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Baseline, n=14, 16	90.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 32, n=11, 14	326.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 12, n=12, 14	217.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 40, n=8, 12	328.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Day 28, n=13, 16	234.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 48, n=8, 13	370.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 24, n=11, 15	242.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 60, n=5, 12	333.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 8, n=11, 16	228.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 72, n=3, 4	299.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time	Week 84, n=0, 1	368.0 Cells per cubic millimeters

Secondary

Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time

Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.

Time frame: Baseline; Day 28; Weeks 12, 24, and 48

Arm	Measure	Group	Value (MEDIAN)
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Baseline, n=14, 16	896.0 Cells per cubic millimeter
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 24, n=11, 15	1160.0 Cells per cubic millimeter
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 12, n=11, 14	1198.0 Cells per cubic millimeter
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 48, n=6, 12	1295.0 Cells per cubic millimeter
DTG 50 mg BID	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Day 28, n=13, 16	1135.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 48, n=6, 12	1147.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Day 28, n=13, 16	973.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Baseline, n=14, 16	808.5 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 12, n=11, 14	1184.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time	Week 24, n=11, 15	1323.0 Cells per cubic millimeter

Secondary

Absolute Values in Plasma HIV-1 RNA Over Time

Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 72, n=3, 4	2.35 Log10 c/mL	Standard Deviation 1.312
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Baseline, n=14, 16	4.02 Log10 c/mL	Standard Deviation 0.94
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 40, n=7, 12	2.35 Log10 c/mL	Standard Deviation 1.169
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Day 8, n=14, 16	2.95 Log10 c/mL	Standard Deviation 0.79
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 8, n=11, 16	2.35 Log10 c/mL	Standard Deviation 0.851
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Day 28, n=13, 16	2.14 Log10 c/mL	Standard Deviation 0.772
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 48, n=8, 13	2.47 Log10 c/mL	Standard Deviation 1.037
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 16, n=12, 16	2.57 Log10 c/mL	Standard Deviation 1.093
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 32, n=11, 14	2.72 Log10 c/mL	Standard Deviation 1.176
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 24, n=11, 15	2.65 Log10 c/mL	Standard Deviation 1.219
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 60, n=5, 12	2.15 Log10 c/mL	Standard Deviation 1.013
DTG 50 mg BID	Absolute Values in Plasma HIV-1 RNA Over Time	Week 12, n=12, 14	2.51 Log10 c/mL	Standard Deviation 1.048
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Day 28, n=13, 16	2.30 Log10 c/mL	Standard Deviation 1.054
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 84, n=0, 1	1.59 Log10 c/mL	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 8, n=11, 16	2.10 Log10 c/mL	Standard Deviation 0.913
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 24, n=11, 15	1.88 Log10 c/mL	Standard Deviation 0.654
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 32, n=11, 14	1.81 Log10 c/mL	Standard Deviation 0.664
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 40, n=7, 12	1.68 Log10 c/mL	Standard Deviation 0.133
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 48, n=8, 13	1.62 Log10 c/mL	Standard Deviation 0.088
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 60, n=5, 12	1.67 Log10 c/mL	Standard Deviation 0.15
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Baseline, n=14, 16	4.42 Log10 c/mL	Standard Deviation 0.76
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Day 8, n=14, 16	4.39 Log10 c/mL	Standard Deviation 0.844
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 12, n=12, 14	2.27 Log10 c/mL	Standard Deviation 1.179
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 16, n=12, 16	2.18 Log10 c/mL	Standard Deviation 1.098
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Absolute Values in Plasma HIV-1 RNA Over Time	Week 72, n=3, 4	1.62 Log10 c/mL	Standard Deviation 0.054

Secondary

AUC(0-tau) of DTG

The area under the time concentration curve over the dosing interval (AUC\[0-tau\]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.

Time frame: Day 8, Day 28, and Week 24

Population: PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
DTG 50 mg BID	AUC(0-tau) of DTG	37.9 µghour per mL (µghr/mL)	Geometric Coefficient of Variation 41.8

Secondary

Change From Baseline in Albumin Level

Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline, Week 24 and 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Albumin Level	Albumin; Baseline; n=14, 16	43.1 grams per liter	Standard Deviation 4.13
DTG 50 mg BID	Change From Baseline in Albumin Level	Albumin; Week 24; n=11, 15	0.0 grams per liter	Standard Deviation 3.66
DTG 50 mg BID	Change From Baseline in Albumin Level	Albumin; Week 48; n=8, 13	1.3 grams per liter	Standard Deviation 2.55
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Albumin Level	Albumin; Baseline; n=14, 16	43.4 grams per liter	Standard Deviation 3.88
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Albumin Level	Albumin; Week 24; n=11, 15	0.0 grams per liter	Standard Deviation 3.87
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Albumin Level	Albumin; Week 48; n=8, 13	-0.8 grams per liter	Standard Deviation 3.69

Secondary

Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase

Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 60; n=5, 12	0.8 International units per liter	Standard Deviation 7.19
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 48; n=8, 13	28.0 International units per liter	Standard Deviation 67.54
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 72; n=3, 4	8.7 International units per liter	Standard Deviation 17.67
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 40; n=8, 12	-1.6 International units per liter	Standard Deviation 8.75
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 60; n=5, 12	6.0 International units per liter	Standard Deviation 23.86
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Baseline; n=14, 16	28.9 International units per liter	Standard Deviation 11.13
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Day 8; n=13, 15	1.0 International units per liter	Standard Deviation 11.5
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 8; n=11, 16	1.6 International units per liter	Standard Deviation 15.6
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Day 28; n=13, 16	-4.0 International units per liter	Standard Deviation 10.13
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 72; n=3, 4	-5.0 International units per liter	Standard Deviation 19.29
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 8; n=11, 16	-2.9 International units per liter	Standard Deviation 7.57
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 72; n=3, 4	35.0 International units per liter	Standard Deviation 68.61
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 12; n=12, 14	-4.8 International units per liter	Standard Deviation 4.07
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 12; n=12, 14	-0.8 International units per liter	Standard Deviation 10.19
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 16; n=10, 16	-4.0 International units per liter	Standard Deviation 2.94
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Baseline; n=14, 16	24.9 International units per liter	Standard Deviation 13.33
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 24; n=11, 15	1.7 International units per liter	Standard Deviation 14.05
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Day 8; n=13, 15	0.0 International units per liter	Standard Deviation 7.02
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 32; n=11, 14	-1.7 International units per liter	Standard Deviation 6.83
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Baseline; n=14, 16	91.9 International units per liter	Standard Deviation 29.64
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 40; n=8, 12	-4.9 International units per liter	Standard Deviation 4.09
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Day 28; n=13, 16	0.4 International units per liter	Standard Deviation 15.45
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 48; n=8, 13	9.0 International units per liter	Standard Deviation 27.77
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 16; n=10, 16	3.1 International units per liter	Standard Deviation 12.02
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 60; n=5, 12	-3.2 International units per liter	Standard Deviation 1.64
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 8; n=11, 16	1.2 International units per liter	Standard Deviation 20.3
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 72; n=3, 4	1.3 International units per liter	Standard Deviation 8.5
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 12; n=12, 14	-18.8 International units per liter	Standard Deviation 105.64
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 12; n=12, 14	-5.4 International units per liter	Standard Deviation 4.94
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Baseline; n=14, 16	162.4 International units per liter	Standard Deviation 129.21
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 24; n=11, 15	1.7 International units per liter	Standard Deviation 21.72
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Day 8; n=13, 15	-2.1 International units per liter	Standard Deviation 122.28
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 16; n=10, 16	-5.2 International units per liter	Standard Deviation 3.97
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Day 28; n=13, 16	-35.6 International units per liter	Standard Deviation 96.22
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Day 8; n=13, 15	1.9 International units per liter	Standard Deviation 14.01
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 8; n=11, 16	-16.4 International units per liter	Standard Deviation 106.99
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 24; n=11, 15	3.1 International units per liter	Standard Deviation 18.66
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 16; n=10, 16	34.2 International units per liter	Standard Deviation 81.44
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 32; n=11, 14	6.9 International units per liter	Standard Deviation 19.74
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 24; n=11, 15	-24.4 International units per liter	Standard Deviation 82.07
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 32; n=11, 14	0.9 International units per liter	Standard Deviation 14.01
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 32; n=11, 14	2.3 International units per liter	Standard Deviation 54.41
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 40; n=8, 12	-50.0 International units per liter	Standard Deviation 93.45
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 48; n=8, 13	7.8 International units per liter	Standard Deviation 71.57
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 40; n=8, 12	2.3 International units per liter	Standard Deviation 20.26
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 60; n=5, 12	-12.2 International units per liter	Standard Deviation 23.3
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 48; n=8, 13	7.9 International units per liter	Standard Deviation 20.02
DTG 50 mg BID	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Day 28; n=13, 16	-6.1 International units per liter	Standard Deviation 10.71
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 40; n=8, 12	66.3 International units per liter	Standard Deviation 168.54
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 48; n=8, 13	16.1 International units per liter	Standard Deviation 68.96
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 72; n=3, 4	-29.0 International units per liter	Standard Deviation 76.27
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Baseline; n=14, 16	37.4 International units per liter	Standard Deviation 22.7
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 84; n=0, 1	-134.0 International units per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Baseline; n=14, 16	34.9 International units per liter	Standard Deviation 14.35
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 12; n=12, 14	0.4 International units per liter	Standard Deviation 84.85
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 32; n=11, 14	23.4 International units per liter	Standard Deviation 96.88
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 60; n=5, 12	18.8 International units per liter	Standard Deviation 86.19
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Baseline; n=14, 16	114.9 International units per liter	Standard Deviation 106.74
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Day 8; n=13, 15	-1.2 International units per liter	Standard Deviation 9.41
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Day 28; n=13, 16	-0.6 International units per liter	Standard Deviation 11.37
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 8; n=11, 16	20.6 International units per liter	Standard Deviation 63.97
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 12; n=12, 14	-0.3 International units per liter	Standard Deviation 26.15
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 16; n=10, 16	8.2 International units per liter	Standard Deviation 40.55
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 24; n=11, 15	3.3 International units per liter	Standard Deviation 54.06
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 32; n=11, 14	20.5 International units per liter	Standard Deviation 35.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 40; n=8, 12	7.8 International units per liter	Standard Deviation 24.69
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 48; n=8, 13	13.8 International units per liter	Standard Deviation 32.07
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 60; n=5, 12	12.8 International units per liter	Standard Deviation 35.98
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 72; n=3, 4	15.3 International units per liter	Standard Deviation 10.21
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALP; Week 84; n=0, 1	22.0 International units per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Day 8; n=13, 15	-3.8 International units per liter	Standard Deviation 11.91
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Day 28; n=13, 16	-5.3 International units per liter	Standard Deviation 23.65
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 8; n=11, 16	-9.2 International units per liter	Standard Deviation 17.93
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 12; n=12, 14	-8.7 International units per liter	Standard Deviation 23.36
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 16; n=10, 16	-10.1 International units per liter	Standard Deviation 23.02
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 24; n=11, 15	-14.5 International units per liter	Standard Deviation 23.16
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 32; n=11, 14	-10.6 International units per liter	Standard Deviation 25.77
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 40; n=8, 12	-7.7 International units per liter	Standard Deviation 25.86
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 48; n=8, 13	-9.2 International units per liter	Standard Deviation 23.5
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 60; n=5, 12	-8.3 International units per liter	Standard Deviation 24.28
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 72; n=3, 4	-29.3 International units per liter	Standard Deviation 33.06
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	ALT; Week 84; n=0, 1	-3.0 International units per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Day 8; n=13, 15	-2.0 International units per liter	Standard Deviation 9.17
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Day 28; n=13, 16	-2.3 International units per liter	Standard Deviation 17.08
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 8; n=11, 16	-6.3 International units per liter	Standard Deviation 9.64
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 12; n=12, 14	-5.1 International units per liter	Standard Deviation 11.78
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 16; n=10, 16	-6.6 International units per liter	Standard Deviation 12.27
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 24; n=11, 15	-10.1 International units per liter	Standard Deviation 11.87
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 32; n=11, 14	-7.4 International units per liter	Standard Deviation 13.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 40; n=8, 12	-4.1 International units per liter	Standard Deviation 12.46
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 48; n=8, 13	-5.4 International units per liter	Standard Deviation 10.47
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 60; n=5, 12	-5.9 International units per liter	Standard Deviation 9.24
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 72; n=3, 4	-13.8 International units per liter	Standard Deviation 12.31
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	AST; Week 84; n=0, 1	-8.0 International units per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Baseline; n=14, 16	130.3 International units per liter	Standard Deviation 76.46
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Day 8; n=13, 15	-1.5 International units per liter	Standard Deviation 53.29
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Day 28; n=13, 16	37.0 International units per liter	Standard Deviation 123.1
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 8; n=11, 16	-7.3 International units per liter	Standard Deviation 68.19
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 16; n=10, 16	80.5 International units per liter	Standard Deviation 305.19
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase	Creatine Kinase; Week 24; n=11, 15	-6.0 International units per liter	Standard Deviation 67.29

Secondary

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count

Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 40; n=8, 12	-0.030 Giga cells per liter	Standard Deviation 0.0685
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Baseline; n=14, 16	1.656 Giga cells per liter	Standard Deviation 0.9039
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Baseline; n=14, 16	0.016 Giga cells per liter	Standard Deviation 0.0122
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Day 28; n=13, 16	0.132 Giga cells per liter	Standard Deviation 0.4841
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Day 8; n=14, 15	0.006 Giga cells per liter	Standard Deviation 0.0134
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 8; n=11, 16	0.490 Giga cells per liter	Standard Deviation 0.5591
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 40; n=8, 12	-0.015 Giga cells per liter	Standard Deviation 0.1285
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 12; n=12, 14	0.417 Giga cells per liter	Standard Deviation 0.9401
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 72; n=3, 4	0.673 Giga cells per liter	Standard Deviation 0.5327
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 16; n=12, 16	0.554 Giga cells per liter	Standard Deviation 0.6402
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 24; n=11, 15	0.271 Giga cells per liter	Standard Deviation 0.7466
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 8; n=11, 16	-0.001 Giga cells per liter	Standard Deviation 0.0122
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 32; n=11, 13	0.173 Giga cells per liter	Standard Deviation 0.7166
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Baseline; n=14, 16	2.327 Giga cells per liter	Standard Deviation 1.2068
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 40; n=8, 12	0.169 Giga cells per liter	Standard Deviation 0.66
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 12; n=12, 14	-0.001 Giga cells per liter	Standard Deviation 0.0144
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 60; n=5, 12	0.526 Giga cells per liter	Standard Deviation 0.3578
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Day 28; n=13, 16	0.005 Giga cells per liter	Standard Deviation 0.0176
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 8; n=11, 16	-0.022 Giga cells per liter	Standard Deviation 0.1256
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 16; n=12, 16	-0.002 Giga cells per liter	Standard Deviation 0.0147
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Baseline; n=14, 16	0.367 Giga cells per liter	Standard Deviation 0.2075
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 24; n=11, 15	0.001 Giga cells per liter	Standard Deviation 0.0158
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 32; n=11, 13	-0.059 Giga cells per liter	Standard Deviation 0.1208
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 12; n=12, 14	0.022 Giga cells per liter	Standard Deviation 0.5946
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 48; n=8, 13	-0.050 Giga cells per liter	Standard Deviation 0.1598
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 32; n=11, 13	0.002 Giga cells per liter	Standard Deviation 0.0108
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 60; n=5, 12	-0.088 Giga cells per liter	Standard Deviation 0.1359
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Day 8; n=14, 15	0.165 Giga cells per liter	Standard Deviation 0.491
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 72; n=3, 4	0.003 Giga cells per liter	Standard Deviation 0.0987
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 40; n=8, 12	-0.000 Giga cells per liter	Standard Deviation 0.0207
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Day 8; n=14, 15	0.003 Giga cells per liter	Standard Deviation 0.2379
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Day 8; n=14, 15	0.090 Giga cells per liter	Standard Deviation 0.9029
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 48; n=8, 13	0.006 Giga cells per liter	Standard Deviation 0.013
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Day 28; n=13, 16	0.196 Giga cells per liter	Standard Deviation 0.7017
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 8; n=11, 16	0.480 Giga cells per liter	Standard Deviation 0.7919
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 16; n=12, 16	0.780 Giga cells per liter	Standard Deviation 1.7187
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 60; n=5, 12	-0.002 Giga cells per liter	Standard Deviation 0.0164
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 24; n=11, 15	-0.128 Giga cells per liter	Standard Deviation 0.7851
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Day 8; n=14, 15	21.6 Giga cells per liter	Standard Deviation 29.23
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 32; n=11, 13	0.213 Giga cells per liter	Standard Deviation 0.9525
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 72; n=3, 4	-0.003 Giga cells per liter	Standard Deviation 0.0153
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 40; n=8, 12	0.224 Giga cells per liter	Standard Deviation 1.0274
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Day 28; n=13, 16	-0.042 Giga cells per liter	Standard Deviation 0.1999
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 48; n=8, 13	0.144 Giga cells per liter	Standard Deviation 0.5807
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Day 28; n=13, 16	33.9 Giga cells per liter	Standard Deviation 29.87
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 60; n=5, 12	0.162 Giga cells per liter	Standard Deviation 0.7959
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 72; n=3, 4	0.783 Giga cells per liter	Standard Deviation 1.6101
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Baseline; n=14, 16	0.087 Giga cells per liter	Standard Deviation 0.0935
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 48; n=8, 13	0.474 Giga cells per liter	Standard Deviation 0.4207
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Baseline; n=14, 16	173.0 Giga cells per liter	Standard Deviation 65.3
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Day 8; n=14, 15	0.016 Giga cells per liter	Standard Deviation 0.0388
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 12; n=12, 14	36.5 Giga cells per liter	Standard Deviation 33.68
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Day 28; n=13, 16	0.023 Giga cells per liter	Standard Deviation 0.0253
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 16; n=12, 16	35.7 Giga cells per liter	Standard Deviation 39.58
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 8; n=11, 16	57.8 Giga cells per liter	Standard Deviation 70.86
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 24; n=11, 15	33.5 Giga cells per liter	Standard Deviation 31.41
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 8; n=11, 16	0.041 Giga cells per liter	Standard Deviation 0.0561
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 32; n=11, 13	12.1 Giga cells per liter	Standard Deviation 33.87
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 48; n=8, 13	24.6 Giga cells per liter	Standard Deviation 36.49
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 12; n=12, 14	0.023 Giga cells per liter	Standard Deviation 0.0492
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 60; n=5, 12	43.0 Giga cells per liter	Standard Deviation 18.36
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 32; n=11, 13	0.016 Giga cells per liter	Standard Deviation 0.1108
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 72; n=3, 4	34.3 Giga cells per liter	Standard Deviation 40.15
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 16; n=12, 16	0.024 Giga cells per liter	Standard Deviation 0.0887
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 40; n=8, 12	25.6 Giga cells per liter	Standard Deviation 38.38
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Baseline; n=14, 16	4.44 Giga cells per liter	Standard Deviation 1.752
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 24; n=11, 15	-0.003 Giga cells per liter	Standard Deviation 0.0987
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Day 8; n=14, 15	0.29 Giga cells per liter	Standard Deviation 1.082
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 12; n=12, 14	-0.053 Giga cells per liter	Standard Deviation 0.1215
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 8; n=11, 16	1.00 Giga cells per liter	Standard Deviation 1.015
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Day 28; n=13, 16	0.33 Giga cells per liter	Standard Deviation 0.946
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 12; n=12, 14	0.42 Giga cells per liter	Standard Deviation 1.192
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 48; n=8, 13	-0.028 Giga cells per liter	Standard Deviation 0.1241
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 16; n=12, 16	1.36 Giga cells per liter	Standard Deviation 2.05
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 16; n=12, 16	-0.027 Giga cells per liter	Standard Deviation 0.1262
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 24; n=11, 15	0.09 Giga cells per liter	Standard Deviation 1.276
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 60; n=5, 12	-0.038 Giga cells per liter	Standard Deviation 0.1392
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 32; n=11, 13	0.35 Giga cells per liter	Standard Deviation 1.264
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 40; n=8, 12	0.36 Giga cells per liter	Standard Deviation 1.162
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 48; n=8, 13	0.56 Giga cells per liter	Standard Deviation 0.655
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 72; n=3, 4	-0.043 Giga cells per liter	Standard Deviation 0.1185
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 60; n=5, 12	0.58 Giga cells per liter	Standard Deviation 0.973
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 24; n=11, 15	-0.067 Giga cells per liter	Standard Deviation 0.1152
DTG 50 mg BID	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 72; n=3, 4	1.43 Giga cells per liter	Standard Deviation 1.21
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 8; n=11, 16	1.02 Giga cells per liter	Standard Deviation 1.008
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 12; n=12, 14	1.19 Giga cells per liter	Standard Deviation 1.005
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 16; n=12, 16	1.86 Giga cells per liter	Standard Deviation 1.398
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 24; n=11, 15	1.59 Giga cells per liter	Standard Deviation 2.075
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 40; n=8, 12	0.93 Giga cells per liter	Standard Deviation 0.965
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 48; n=8, 13	1.70 Giga cells per liter	Standard Deviation 1.48
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 60; n=5, 12	2.25 Giga cells per liter	Standard Deviation 1.579
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 84; n=0, 1	0.640 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Day 8; n=14, 15	0.005 Giga cells per liter	Standard Deviation 0.1076
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 24; n=11, 15	0.159 Giga cells per liter	Standard Deviation 0.3737
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Baseline; n=14, 16	1.418 Giga cells per liter	Standard Deviation 0.7921
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 16; n=12, 16	0.594 Giga cells per liter	Standard Deviation 0.7014
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 48; n=8, 13	0.563 Giga cells per liter	Standard Deviation 0.5703
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 60; n=5, 12	0.663 Giga cells per liter	Standard Deviation 0.6135
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 72; n=3, 4	0.623 Giga cells per liter	Standard Deviation 0.428
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Baseline; n=14, 16	0.306 Giga cells per liter	Standard Deviation 0.1117
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Day 8; n=14, 15	0.027 Giga cells per liter	Standard Deviation 0.146
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Day 28; n=13, 16	0.031 Giga cells per liter	Standard Deviation 0.1196
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 8; n=11, 16	0.037 Giga cells per liter	Standard Deviation 0.1111
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 40; n=8, 12	0.011 Giga cells per liter	Standard Deviation 0.0983
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 72; n=3, 4	0.055 Giga cells per liter	Standard Deviation 0.1196
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Day 28; n=13, 16	0.659 Giga cells per liter	Standard Deviation 0.9376
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 8; n=11, 16	0.344 Giga cells per liter	Standard Deviation 0.7325
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 12; n=12, 14	0.357 Giga cells per liter	Standard Deviation 0.541
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 60; n=5, 12	1.507 Giga cells per liter	Standard Deviation 1.7191
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Baseline; n=14, 16	176.9 Giga cells per liter	Standard Deviation 56.97
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Day 8; n=14, 15	16.5 Giga cells per liter	Standard Deviation 29.08
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Day 28; n=13, 16	30.8 Giga cells per liter	Standard Deviation 43.76
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 32; n=11, 13	55.6 Giga cells per liter	Standard Deviation 74.6
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Day 8; n=14, 15	0.15 Giga cells per liter	Standard Deviation 0.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 32; n=11, 13	1.78 Giga cells per liter	Standard Deviation 1.6
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 72; n=3, 4	3.10 Giga cells per liter	Standard Deviation 2.349
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Week 84; n=0, 1	2.70 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Day 8; n=14, 15	0.002 Giga cells per liter	Standard Deviation 0.0094
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Day 28; n=13, 16	0.004 Giga cells per liter	Standard Deviation 0.0222
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 8; n=11, 16	0.004 Giga cells per liter	Standard Deviation 0.012
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 12; n=12, 14	0.000 Giga cells per liter	Standard Deviation 0.0124
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 16; n=12, 16	0.005 Giga cells per liter	Standard Deviation 0.0137
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 24; n=11, 15	0.007 Giga cells per liter	Standard Deviation 0.0188
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 32; n=11, 13	0.005 Giga cells per liter	Standard Deviation 0.0185
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 40; n=8, 12	0.003 Giga cells per liter	Standard Deviation 0.0144
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 48; n=8, 13	0.008 Giga cells per liter	Standard Deviation 0.0174
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 60; n=5, 12	0.004 Giga cells per liter	Standard Deviation 0.0173
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 72; n=3, 4	0.008 Giga cells per liter	Standard Deviation 0.0275
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Week 84; n=0, 1	0.010 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Baseline; n=14, 16	0.158 Giga cells per liter	Standard Deviation 0.1681
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Day 28; n=13, 16	0.033 Giga cells per liter	Standard Deviation 0.1939
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 8; n=11, 16	0.090 Giga cells per liter	Standard Deviation 0.1464
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 12; n=12, 14	0.240 Giga cells per liter	Standard Deviation 0.439
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 16; n=12, 16	0.141 Giga cells per liter	Standard Deviation 0.3009
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 32; n=11, 13	0.075 Giga cells per liter	Standard Deviation 0.1921
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 40; n=8, 12	0.011 Giga cells per liter	Standard Deviation 0.1054
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 48; n=8, 13	0.122 Giga cells per liter	Standard Deviation 0.2186
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 60; n=5, 12	0.098 Giga cells per liter	Standard Deviation 0.2143
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 72; n=3, 4	0.053 Giga cells per liter	Standard Deviation 0.066
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Eosinophils; Week 84; n=0, 1	0.240 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Day 8; n=14, 15	0.040 Giga cells per liter	Standard Deviation 0.3262
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Day 28; n=13, 16	0.297 Giga cells per liter	Standard Deviation 0.3042
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 8; n=11, 16	0.536 Giga cells per liter	Standard Deviation 0.6238
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 12; n=12, 14	0.525 Giga cells per liter	Standard Deviation 0.4922
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 24; n=11, 15	0.647 Giga cells per liter	Standard Deviation 0.8692
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 32; n=11, 13	0.818 Giga cells per liter	Standard Deviation 0.691
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Lymphocytes; Week 40; n=8, 12	0.519 Giga cells per liter	Standard Deviation 0.6709
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Basophils; Baseline; n=14, 16	0.015 Giga cells per liter	Standard Deviation 0.0126
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 12; n=12, 14	0.065 Giga cells per liter	Standard Deviation 0.1075
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 16; n=12, 16	0.089 Giga cells per liter	Standard Deviation 0.143
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 24; n=11, 15	0.017 Giga cells per liter	Standard Deviation 0.1716
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 32; n=11, 13	0.017 Giga cells per liter	Standard Deviation 0.1616
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 48; n=8, 13	0.018 Giga cells per liter	Standard Deviation 0.0985
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 60; n=5, 12	-0.003 Giga cells per liter	Standard Deviation 0.1305
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Monocytes; Week 84; n=0, 1	-0.230 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Baseline; n=14, 16	1.869 Giga cells per liter	Standard Deviation 1.0565
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Day 8; n=14, 15	0.072 Giga cells per liter	Standard Deviation 0.6338
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 16; n=12, 16	1.030 Giga cells per liter	Standard Deviation 0.7759
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 24; n=11, 15	0.746 Giga cells per liter	Standard Deviation 1.3053
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 32; n=11, 13	0.875 Giga cells per liter	Standard Deviation 1.0945
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 40; n=8, 12	0.390 Giga cells per liter	Standard Deviation 0.4501
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 48; n=8, 13	0.986 Giga cells per liter	Standard Deviation 1.0983
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 72; n=3, 4	2.363 Giga cells per liter	Standard Deviation 2.0072
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Total neutrophils; Week 84; n=0, 1	2.060 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 8; n=11, 16	29.1 Giga cells per liter	Standard Deviation 57.51
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 12; n=12, 14	39.2 Giga cells per liter	Standard Deviation 56.51
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 16; n=12, 16	52.6 Giga cells per liter	Standard Deviation 56.43
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 24; n=11, 15	58.7 Giga cells per liter	Standard Deviation 64.1
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 40; n=8, 12	44.9 Giga cells per liter	Standard Deviation 48.17
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 48; n=8, 13	53.5 Giga cells per liter	Standard Deviation 63.73
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 60; n=5, 12	51.5 Giga cells per liter	Standard Deviation 58.12
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 72; n=3, 4	64.0 Giga cells per liter	Standard Deviation 94.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	Platelet; Week 84; n=0, 1	88.0 Giga cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Baseline; n=14, 16	3.78 Giga cells per liter	Standard Deviation 1.522
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count	WBC; Day 28; n=13, 16	1.03 Giga cells per liter	Standard Deviation 1.105

Secondary

Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen

Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Lipid and glucose parameters were only summarized on fasting data. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Baseline; n=8, 10	3.819 Millimoles per liter	Standard Deviation 0.9219
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 48; n=3, 7	0.567 Millimoles per liter	Standard Deviation 0.2021
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Day 28; n=13, 16	0.4 Millimoles per liter	Standard Deviation 2.26
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Baseline; n=14, 16	22.5 Millimoles per liter	Standard Deviation 2.07
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 40; n=8, 12	0.9 Millimoles per liter	Standard Deviation 2.3
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 72; n=3, 4	2.0 Millimoles per liter	Standard Deviation 3.61
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Day 28; n=13, 16	0.19 Millimoles per liter	Standard Deviation 0.439
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 16; n=10, 16	-0.06 Millimoles per liter	Standard Deviation 0.36
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 32; n=11, 14	-0.04 Millimoles per liter	Standard Deviation 0.329
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 40; n=8, 12	-0.01 Millimoles per liter	Standard Deviation 0.189
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 60; n=5, 12	0.06 Millimoles per liter	Standard Deviation 0.288
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 72; n=3, 4	0.37 Millimoles per liter	Standard Deviation 0.208
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Baseline; n=8, 9	2.218 Millimoles per liter	Standard Deviation 0.9134
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 12; n=6, 8	0.293 Millimoles per liter	Standard Deviation 0.4197
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 24; n=6, 9	0.032 Millimoles per liter	Standard Deviation 0.5854
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 24; n=11, 15	0.5 Millimoles per liter	Standard Deviation 1.51
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 40; n=8, 12	1.0 Millimoles per liter	Standard Deviation 2.14
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 40; n=8, 12	0.000 Millimoles per liter	Standard Deviation 0.1035
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 48; n=8, 13	0.025 Millimoles per liter	Standard Deviation 0.1282
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 60; n=5, 12	0.020 Millimoles per liter	Standard Deviation 0.1304
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 48; n=3, 7	0.260 Millimoles per liter	Standard Deviation 0.3894
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Day 8; n=13, 15	0.04 Millimoles per liter	Standard Deviation 1.233
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 60; n=5, 12	0.30 Millimoles per liter	Standard Deviation 0.908
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 72; n=3, 4	0.50 Millimoles per liter	Standard Deviation 0.5
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 12; n=6, 8	0.433 Millimoles per liter	Standard Deviation 0.4622
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 24; n=6, 10	0.308 Millimoles per liter	Standard Deviation 0.3137
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 60; n=2, 5	0.375 Millimoles per liter	Standard Deviation 0.9546
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Baseline; n=14, 16	104.1 Millimoles per liter	Standard Deviation 1.59
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Day 8; n=13, 15	0.5 Millimoles per liter	Standard Deviation 1.61
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 8; n=11, 16	0.5 Millimoles per liter	Standard Deviation 1.97
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 12; n=12, 14	-0.8 Millimoles per liter	Standard Deviation 1.71
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 16; n=10, 16	1.4 Millimoles per liter	Standard Deviation 1.9
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 24; n=11, 15	0.9 Millimoles per liter	Standard Deviation 1.45
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 32; n=11, 14	1.1 Millimoles per liter	Standard Deviation 2.21
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 40; n=8, 12	0.5 Millimoles per liter	Standard Deviation 2.51
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 48; n=8, 13	1.5 Millimoles per liter	Standard Deviation 3.74
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 60; n=5, 12	2.0 Millimoles per liter	Standard Deviation 2.12
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 72; n=3, 4	2.0 Millimoles per liter	Standard Deviation 2.65
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Day 8; n=13, 15	0.2 Millimoles per liter	Standard Deviation 1.3
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Day 28; n=13, 16	0.4 Millimoles per liter	Standard Deviation 2.29
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 8; n=11, 16	1.2 Millimoles per liter	Standard Deviation 1.66
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 12; n=12, 14	1.7 Millimoles per liter	Standard Deviation 1.92
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 16; n=10, 16	-0.2 Millimoles per liter	Standard Deviation 2.39
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 24; n=11, 15	0.9 Millimoles per liter	Standard Deviation 1.92
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 32; n=11, 14	1.5 Millimoles per liter	Standard Deviation 2.21
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 48; n=8, 13	-0.4 Millimoles per liter	Standard Deviation 2.13
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 60; n=5, 12	0.8 Millimoles per liter	Standard Deviation 1.3
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Baseline; n=12, 16	4.84 Millimoles per liter	Standard Deviation 0.535
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 12; n=11, 14	-0.01 Millimoles per liter	Standard Deviation 0.677
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 24; n=10, 15	0.17 Millimoles per liter	Standard Deviation 0.957
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 48; n=7, 13	0.13 Millimoles per liter	Standard Deviation 0.439
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 60; n=3, 12	0.20 Millimoles per liter	Standard Deviation 0.3
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 72; n=2, 4	0.45 Millimoles per liter	Standard Deviation 0.071
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Baseline; n=8, 10	0.956 Millimoles per liter	Standard Deviation 0.2718
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 12; n=6, 8	0.117 Millimoles per liter	Standard Deviation 0.0683
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 24; n=6, 10	0.025 Millimoles per liter	Standard Deviation 0.1864
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 48; n=3, 7	0.117 Millimoles per liter	Standard Deviation 0.1155
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 60; n=2, 5	-0.025 Millimoles per liter	Standard Deviation 0.0354
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Baseline; n=14, 16	4.16 Millimoles per liter	Standard Deviation 0.42
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Day 8; n=13, 15	-0.09 Millimoles per liter	Standard Deviation 0.198
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 8; n=11, 16	0.12 Millimoles per liter	Standard Deviation 0.379
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 12; n=12, 14	0.03 Millimoles per liter	Standard Deviation 0.253
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 24; n=11, 15	0.17 Millimoles per liter	Standard Deviation 0.374
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 48; n=8, 13	0.15 Millimoles per liter	Standard Deviation 0.532
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 48; n=3, 6	0.330 Millimoles per liter	Standard Deviation 0.0458
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 60; n=2, 4	0.125 Millimoles per liter	Standard Deviation 0.5303
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Baseline; n=14, 16	138.8 Millimoles per liter	Standard Deviation 2.26
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Day 8; n=13, 15	0.2 Millimoles per liter	Standard Deviation 1.64
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Day 28; n=13, 16	-0.2 Millimoles per liter	Standard Deviation 3.11
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 8; n=11, 16	0.2 Millimoles per liter	Standard Deviation 2.14
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 12; n=12, 14	-0.5 Millimoles per liter	Standard Deviation 1.88
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 16; n=10, 16	1.3 Millimoles per liter	Standard Deviation 2.06
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 32; n=11, 14	0.8 Millimoles per liter	Standard Deviation 1.6
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 48; n=8, 13	0.9 Millimoles per liter	Standard Deviation 3.56
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 60; n=5, 12	2.4 Millimoles per liter	Standard Deviation 1.95
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 72; n=3, 4	1.3 Millimoles per liter	Standard Deviation 2.52
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Baseline; n=14, 16	1.018 Millimoles per liter	Standard Deviation 0.1552
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Day 8; n=13, 15	0.012 Millimoles per liter	Standard Deviation 0.1261
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Day 28; n=13, 16	0.065 Millimoles per liter	Standard Deviation 0.2357
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 8; n=11, 16	0.018 Millimoles per liter	Standard Deviation 0.1722
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 12; n=12, 14	0.033 Millimoles per liter	Standard Deviation 0.1542
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 16; n=10, 16	0.080 Millimoles per liter	Standard Deviation 0.2263
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 24; n=11, 15	-0.050 Millimoles per liter	Standard Deviation 0.1204
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 32; n=11, 14	-0.036 Millimoles per liter	Standard Deviation 0.1343
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 72; n=3, 4	0.017 Millimoles per liter	Standard Deviation 0.1258
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Baseline; n=8, 10	1.410 Millimoles per liter	Standard Deviation 0.5005
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 12; n=6, 8	0.047 Millimoles per liter	Standard Deviation 0.638
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 24; n=6, 10	0.547 Millimoles per liter	Standard Deviation 0.9273
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 60; n=2, 5	0.590 Millimoles per liter	Standard Deviation 0.8344
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Baseline; n=14, 16	5.64 Millimoles per liter	Standard Deviation 1.167
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Day 28; n=13, 16	-0.23 Millimoles per liter	Standard Deviation 1.678
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 8; n=11, 16	-0.09 Millimoles per liter	Standard Deviation 1.2
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 12; n=12, 14	0.25 Millimoles per liter	Standard Deviation 1.27
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 16; n=10, 16	-0.05 Millimoles per liter	Standard Deviation 1.787
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 24; n=11, 15	-0.09 Millimoles per liter	Standard Deviation 1.2
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 32; n=11, 14	-0.55 Millimoles per liter	Standard Deviation 1.15
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 40; n=8, 12	-0.19 Millimoles per liter	Standard Deviation 1.387
DTG 50 mg BID	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 48; n=8, 13	0.38 Millimoles per liter	Standard Deviation 1.157
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 60; n=5, 12	0.3 Millimoles per liter	Standard Deviation 2.42
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 72; n=3, 4	-0.3 Millimoles per liter	Standard Deviation 1.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 84; n=0, 1	4.0 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 32; n=11, 14	0.1 Millimoles per liter	Standard Deviation 1.41
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Baseline; n=12, 16	5.56 Millimoles per liter	Standard Deviation 1.994
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 12; n=12, 14	-0.50 Millimoles per liter	Standard Deviation 1.676
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 12; n=11, 14	0.04 Millimoles per liter	Standard Deviation 0.679
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 48; n=8, 13	0.9 Millimoles per liter	Standard Deviation 2.4
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 24; n=10, 15	-0.08 Millimoles per liter	Standard Deviation 1.024
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Day 28; n=13, 16	-0.13 Millimoles per liter	Standard Deviation 1.875
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 48; n=7, 13	0.40 Millimoles per liter	Standard Deviation 1.143
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 60; n=5, 12	0.7 Millimoles per liter	Standard Deviation 2.46
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Day 8; n=13, 15	0.4 Millimoles per liter	Standard Deviation 2.03
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 60; n=3, 12	-0.18 Millimoles per liter	Standard Deviation 0.723
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 48; n=8, 13	-0.1 Millimoles per liter	Standard Deviation 3.38
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 12; n=6, 8	-0.260 Millimoles per liter	Standard Deviation 1.1159
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Baseline; n=14, 16	20.8 Millimoles per liter	Standard Deviation 4.12
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Glucose; Week 72; n=2, 4	0.20 Millimoles per liter	Standard Deviation 0.744
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 40; n=8, 12	-0.2 Millimoles per liter	Standard Deviation 2.25
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 72; n=3, 4	0.3 Millimoles per liter	Standard Deviation 1.5
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Baseline; n=8, 10	1.090 Millimoles per liter	Standard Deviation 0.2846
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 84; n=0, 1	0.0 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 24; n=11, 15	0.27 Millimoles per liter	Standard Deviation 0.641
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 12; n=6, 8	0.156 Millimoles per liter	Standard Deviation 0.2485
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 32; n=11, 14	0.27 Millimoles per liter	Standard Deviation 0.327
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 40; n=8, 12	0.29 Millimoles per liter	Standard Deviation 1.339
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 40; n=8, 12	0.12 Millimoles per liter	Standard Deviation 0.259
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 48; n=8, 13	0.28 Millimoles per liter	Standard Deviation 0.508
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 24; n=6, 10	0.130 Millimoles per liter	Standard Deviation 0.2573
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 60; n=5, 12	0.03 Millimoles per liter	Standard Deviation 0.614
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 24; n=6, 10	-0.458 Millimoles per liter	Standard Deviation 1.2066
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 72; n=3, 4	0.02 Millimoles per liter	Standard Deviation 0.512
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 84; n=0, 1	0.20 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 48; n=3, 7	0.136 Millimoles per liter	Standard Deviation 0.3363
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Baseline; n=8, 9	2.591 Millimoles per liter	Standard Deviation 1.3696
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Day 8; n=13, 15	-0.123 Millimoles per liter	Standard Deviation 0.1635
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 12; n=6, 8	0.500 Millimoles per liter	Standard Deviation 0.5145
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 60; n=2, 5	0.010 Millimoles per liter	Standard Deviation 0.3896
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 24; n=6, 9	0.596 Millimoles per liter	Standard Deviation 0.7389
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	HDL Cholesterol; Week 72; n=0, 1	0.350 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 48; n=3, 7	-0.486 Millimoles per liter	Standard Deviation 1.3993
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 40; n=8, 12	0.5 Millimoles per liter	Standard Deviation 1.57
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Baseline; n=14, 16	1.128 Millimoles per liter	Standard Deviation 0.139
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 16; n=10, 16	-0.053 Millimoles per liter	Standard Deviation 0.2617
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 32; n=11, 14	-0.050 Millimoles per liter	Standard Deviation 0.1787
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Baseline; n=14, 16	4.13 Millimoles per liter	Standard Deviation 0.377
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Day 28; n=13, 16	-0.075 Millimoles per liter	Standard Deviation 0.1713
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Day 8; n=13, 15	-0.01 Millimoles per liter	Standard Deviation 0.301
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 60; n=5, 12	-0.042 Millimoles per liter	Standard Deviation 0.1311
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Baseline; n=8, 10	2.336 Millimoles per liter	Standard Deviation 1.1103
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Day 28; n=13, 16	0.14 Millimoles per liter	Standard Deviation 0.518
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 8; n=11, 16	-0.59 Millimoles per liter	Standard Deviation 1.985
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 16; n=10, 16	-1.00 Millimoles per liter	Standard Deviation 1.304
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 24; n=11, 15	-0.27 Millimoles per liter	Standard Deviation 1.841
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 48; n=8, 13	0.88 Millimoles per liter	Standard Deviation 1.927
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 8; n=11, 16	0.19 Millimoles per liter	Standard Deviation 0.421
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 60; n=5, 12	0.54 Millimoles per liter	Standard Deviation 1.888
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 8; n=11, 16	-0.075 Millimoles per liter	Standard Deviation 0.2244
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 72; n=3, 4	0.50 Millimoles per liter	Standard Deviation 0.408
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 84; n=0, 1	0.00 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Baseline; n=8, 10	4.725 Millimoles per liter	Standard Deviation 1.743
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 12; n=12, 14	0.06 Millimoles per liter	Standard Deviation 0.373
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 12; n=6, 8	0.538 Millimoles per liter	Standard Deviation 0.9598
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Potassium; Week 16; n=10, 16	-0.08 Millimoles per liter	Standard Deviation 0.556
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 24; n=6, 10	0.585 Millimoles per liter	Standard Deviation 1.0296
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 48; n=3, 7	0.421 Millimoles per liter	Standard Deviation 1.277
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 60; n=2, 5	-0.580 Millimoles per liter	Standard Deviation 1.0562
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 60; n=2, 5	-0.020 Millimoles per liter	Standard Deviation 1.3326
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Cholesterol; Week 72; n=0, 1	1.350 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 12; n=12, 14	-0.054 Millimoles per liter	Standard Deviation 0.1322
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Baseline; n=14, 16	105.4 Millimoles per liter	Standard Deviation 3.32
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Triglycerides; Week 72; n=0, 1	-0.240 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Day 28; n=13, 16	-0.5 Millimoles per liter	Standard Deviation 2.58
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 48; n=3, 6	0.322 Millimoles per liter	Standard Deviation 0.7725
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 8; n=11, 16	-1.8 Millimoles per liter	Standard Deviation 3.08
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Week 32; n=11, 14	0.57 Millimoles per liter	Standard Deviation 1.708
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 12; n=12, 14	0.1 Millimoles per liter	Standard Deviation 2.73
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 60; n=2, 4	-0.008 Millimoles per liter	Standard Deviation 1.0682
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 16; n=10, 16	-1.0 Millimoles per liter	Standard Deviation 2.73
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	LDL Cholesterol; Week 72; n=0, 1	1.110 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 24; n=11, 15	-1.2 Millimoles per liter	Standard Deviation 3.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 24; n=11, 15	-0.023 Millimoles per liter	Standard Deviation 0.1954
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 32; n=11, 14	0.0 Millimoles per liter	Standard Deviation 2.57
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Baseline; n=14, 16	138.5 Millimoles per liter	Standard Deviation 2.22
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 40; n=8, 12	1.3 Millimoles per liter	Standard Deviation 2.8
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Baseline; n=14, 16	5.72 Millimoles per liter	Standard Deviation 2.324
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Day 8; n=13, 15	-0.1 Millimoles per liter	Standard Deviation 2.02
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 60; n=5, 12	1.1 Millimoles per liter	Standard Deviation 2.81
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 40; n=8, 12	-0.046 Millimoles per liter	Standard Deviation 0.234
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 72; n=3, 4	1.0 Millimoles per liter	Standard Deviation 2.94
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Chloride; Week 84; n=0, 1	-2.0 Millimoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Day 28; n=13, 16	-0.4 Millimoles per liter	Standard Deviation 2.6
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Day 8; n=13, 15	0.1 Millimoles per liter	Standard Deviation 2.25
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 48; n=8, 13	-0.031 Millimoles per liter	Standard Deviation 0.1331
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Day 28; n=13, 16	1.1 Millimoles per liter	Standard Deviation 2.47
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 8; n=11, 16	-0.4 Millimoles per liter	Standard Deviation 2.03
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 8; n=11, 16	1.6 Millimoles per liter	Standard Deviation 3.4
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Urea/BUN; Day 8; n=13, 15	-0.43 Millimoles per liter	Standard Deviation 1.252
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 12; n=12, 14	1.9 Millimoles per liter	Standard Deviation 2.73
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 12; n=12, 14	0.4 Millimoles per liter	Standard Deviation 2.53
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 16; n=10, 16	1.8 Millimoles per liter	Standard Deviation 3.42
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 72; n=3, 4	0.013 Millimoles per liter	Standard Deviation 0.1031
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 24; n=11, 15	1.5 Millimoles per liter	Standard Deviation 2.92
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 16; n=10, 16	0.2 Millimoles per liter	Standard Deviation 1.94
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 32; n=11, 14	0.8 Millimoles per liter	Standard Deviation 2.69
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Sodium; Week 24; n=11, 15	-0.1 Millimoles per liter	Standard Deviation 2.33
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	CO2/HCO3; Week 48; n=8, 13	1.7 Millimoles per liter	Standard Deviation 3.01
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen	Phosphorus, inorganic; Week 84; n=0, 1	0.100 Millimoles per liter	—

Secondary

Change From Baseline in Creatinine Clearance

Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Week 16; n=10, 15	-7.3 Milliliters per minute	Standard Deviation 12
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Week 24; n=11, 15	-2.3 Milliliters per minute	Standard Deviation 13.94
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Day 8; n=1, 0	-13.0 Milliliters per minute	—
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Week 32; n=9, 14	-1.4 Milliliters per minute	Standard Deviation 8.82
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Day 28; n=13, 16	-10.5 Milliliters per minute	Standard Deviation 13.06
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Week 48; n=6, 12	-6.8 Milliliters per minute	Standard Deviation 17.61
DTG 50 mg BID	Change From Baseline in Creatinine Clearance	Baseline; n=14, 16	106.8 Milliliters per minute	Standard Deviation 31.79
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Week 48; n=6, 12	-16.5 Milliliters per minute	Standard Deviation 14.34
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Baseline; n=14, 16	104.8 Milliliters per minute	Standard Deviation 36.96
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Day 28; n=13, 16	-10.4 Milliliters per minute	Standard Deviation 13.06
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Week 16; n=10, 15	-12.5 Milliliters per minute	Standard Deviation 16.41
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Week 24; n=11, 15	-13.9 Milliliters per minute	Standard Deviation 17.38
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Week 32; n=9, 14	-16.0 Milliliters per minute	Standard Deviation 16.31
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Creatinine Clearance	Week 8; n=0, 1	-12.0 Milliliters per minute	—

Secondary

Change From Baseline in Heart Rate

Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline and Weeks 24 and 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Heart Rate	Baseline; n=14, 16	72.5 beats per minute	Standard Deviation 9.7
DTG 50 mg BID	Change From Baseline in Heart Rate	Week 24; n=11, 15	-1.4 beats per minute	Standard Deviation 8.42
DTG 50 mg BID	Change From Baseline in Heart Rate	Week 48; 6, 12	2.2 beats per minute	Standard Deviation 11.03
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Heart Rate	Baseline; n=14, 16	75.9 beats per minute	Standard Deviation 14.56
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Heart Rate	Week 24; n=11, 15	0.7 beats per minute	Standard Deviation 11.2
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Heart Rate	Week 48; 6, 12	-2.5 beats per minute	Standard Deviation 17.76

Secondary

Change From Baseline in Hematocrit Level

Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 24; n=11, 15	-0.0025 Proportion of red blood cells in blood	Standard Deviation 0.03707
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 16; n=12, 16	-0.0033 Proportion of red blood cells in blood	Standard Deviation 0.04275
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 8; n=11, 16	-0.0105 Proportion of red blood cells in blood	Standard Deviation 0.04383
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 32; n=11, 13	-0.0081 Proportion of red blood cells in blood	Standard Deviation 0.0331
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Day 28; n=13, 16	-0.0066 Proportion of red blood cells in blood	Standard Deviation 0.03105
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 40; n=8, 12	-0.0005 Proportion of red blood cells in blood	Standard Deviation 0.03257
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 72; n=3, 4	-0.0170 Proportion of red blood cells in blood	Standard Deviation 0.03119
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 48; n=8, 13	0.0065 Proportion of red blood cells in blood	Standard Deviation 0.02919
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Baseline; n=14, 16	0.4024 Proportion of red blood cells in blood	Standard Deviation 0.05259
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 60; n=5, 12	-0.0024 Proportion of red blood cells in blood	Standard Deviation 0.04
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Week 12; n=12, 14	-0.0027 Proportion of red blood cells in blood	Standard Deviation 0.03702
DTG 50 mg BID	Change From Baseline in Hematocrit Level	Day 8; n=14, 15	-0.0015 Proportion of red blood cells in blood	Standard Deviation 0.02666
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Day 8; n=14, 15	-0.0049 Proportion of red blood cells in blood	Standard Deviation 0.01515
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 84; n=0, 1	-0.0090 Proportion of red blood cells in blood	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Day 28; n=13, 16	-0.0043 Proportion of red blood cells in blood	Standard Deviation 0.03313
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 8; n=11, 16	0.0092 Proportion of red blood cells in blood	Standard Deviation 0.04092
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 24; n=11, 15	0.0062 Proportion of red blood cells in blood	Standard Deviation 0.02787
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 60; n=5, 12	0.0200 Proportion of red blood cells in blood	Standard Deviation 0.0452
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Baseline; n=14, 16	0.3974 Proportion of red blood cells in blood	Standard Deviation 0.06496
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 12; n=12, 14	0.0054 Proportion of red blood cells in blood	Standard Deviation 0.03419
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 16; n=12, 16	0.0021 Proportion of red blood cells in blood	Standard Deviation 0.03054
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 32; n=11, 13	0.0062 Proportion of red blood cells in blood	Standard Deviation 0.03144
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 40; n=8, 12	0.0063 Proportion of red blood cells in blood	Standard Deviation 0.03601
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 48; n=8, 13	0.0078 Proportion of red blood cells in blood	Standard Deviation 0.04331
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hematocrit Level	Week 72; n=3, 4	0.0248 Proportion of red blood cells in blood	Standard Deviation 0.02943

Secondary

Change From Baseline in Hemoglobin Level

Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 60; n=5, 12	-1.8 Grams per liter	Standard Deviation 13.99
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 72; n=3, 4	-4.3 Grams per liter	Standard Deviation 7.37
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 12; n=12, 14	-1.0 Grams per liter	Standard Deviation 12.59
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Day 8; n=14, 15	-1.0 Grams per liter	Standard Deviation 6.98
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Day 28; n=13, 16	-2.5 Grams per liter	Standard Deviation 8.76
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 8; n=11, 16	-4.5 Grams per liter	Standard Deviation 13.71
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 16; n=12 16	0.0 Grams per liter	Standard Deviation 15.47
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 24; n=11, 15	-0.6 Grams per liter	Standard Deviation 10.6
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 32; n=11, 13	-2.4 Grams per liter	Standard Deviation 10.66
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 40; n=8, 12	-0.9 Grams per liter	Standard Deviation 12.14
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Week 48; n=8, 13	0.0 Grams per liter	Standard Deviation 9.8
DTG 50 mg BID	Change From Baseline in Hemoglobin Level	Baseline; n=14, 16	132.9 Grams per liter	Standard Deviation 16.16
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 40; n=8, 12	0.7 Grams per liter	Standard Deviation 11.32
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 12; n=12, 14	2.1 Grams per liter	Standard Deviation 11.02
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 60; n=5, 12	5.0 Grams per liter	Standard Deviation 13.22
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 32; n=11, 13	1.5 Grams per liter	Standard Deviation 9.49
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 72; n=3, 4	7.0 Grams per liter	Standard Deviation 8.72
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 84; n=0, 1	-6.0 Grams per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 8; n=11, 16	2.6 Grams per liter	Standard Deviation 12.48
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 16; n=12 16	1.9 Grams per liter	Standard Deviation 10.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Baseline; n=14, 16	129.9 Grams per liter	Standard Deviation 21.08
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 48; n=8, 13	0.5 Grams per liter	Standard Deviation 13.48
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Day 8; n=14, 15	-1.3 Grams per liter	Standard Deviation 4.37
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Week 24; n=11, 15	1.5 Grams per liter	Standard Deviation 8.82
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Hemoglobin Level	Day 28; n=13, 16	-0.9 Grams per liter	Standard Deviation 9.62

Secondary

Change From Baseline in Lipase Levels

Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 16; n=10, 16	7.6 Units per liter	Standard Deviation 13.94
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Baseline; n=14, 16	29.1 Units per liter	Standard Deviation 12.37
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 24; n=11, 15	-2.7 Units per liter	Standard Deviation 9.91
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 8; n=11, 16	2.6 Units per liter	Standard Deviation 8.65
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 32; n=11, 14	0.8 Units per liter	Standard Deviation 9.82
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 40; n=8, 12	0.6 Units per liter	Standard Deviation 8.53
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 48; n=8, 13	3.8 Units per liter	Standard Deviation 6.18
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 60; n=5, 12	5.0 Units per liter	Standard Deviation 8.4
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 12; n=11, 14	-2.4 Units per liter	Standard Deviation 8.91
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Week 72; n=3, 4	16.0 Units per liter	Standard Deviation 14.11
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Day 28; n=13, 16	3.3 Units per liter	Standard Deviation 9.18
DTG 50 mg BID	Change From Baseline in Lipase Levels	Lipase; Day 8; n=14, 15	3.4 Units per liter	Standard Deviation 9.19
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 72; n=3, 4	41.0 Units per liter	Standard Deviation 94.2
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 84; n=0, 1	-9.0 Units per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Day 8; n=14, 15	12.5 Units per liter	Standard Deviation 32.97
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 32; n=11, 14	20.6 Units per liter	Standard Deviation 49.7
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 48; n=8, 13	3.4 Units per liter	Standard Deviation 16.05
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Baseline; n=14, 16	34.0 Units per liter	Standard Deviation 18.54
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Day 28; n=13, 16	17.7 Units per liter	Standard Deviation 63.64
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 8; n=11, 16	13.6 Units per liter	Standard Deviation 42.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 12; n=11, 14	3.0 Units per liter	Standard Deviation 19.24
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 16; n=10, 16	-0.8 Units per liter	Standard Deviation 12.9
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 24; n=11, 15	10.5 Units per liter	Standard Deviation 29.18
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 40; n=8, 12	5.6 Units per liter	Standard Deviation 19.78
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Lipase Levels	Lipase; Week 60; n=5, 12	5.9 Units per liter	Standard Deviation 22.01

Secondary

Change From Baseline in Mean Corpuscle Volume

Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Day 28; n=13, 16	1.2 Femtoliter	Standard Deviation 3.26
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Day 8; n=14, 15	0.1 Femtoliter	Standard Deviation 2.35
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 8; n=11, 16	0.3 Femtoliter	Standard Deviation 3.77
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 12; n=12, 14	1.1 Femtoliter	Standard Deviation 7.73
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 72; n=3, 4	0.3 Femtoliter	Standard Deviation 10.12
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Baseline; n=14, 16	99.1 Femtoliter	Standard Deviation 8.83
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 16; n=12, 16	0.3 Femtoliter	Standard Deviation 7.84
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 24; n=11, 15	-0.3 Femtoliter	Standard Deviation 8.25
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 32; n=11, 13	-1.0 Femtoliter	Standard Deviation 8.54
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 40; n=8, 12	2.5 Femtoliter	Standard Deviation 8.75
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 48; n=8, 13	2.0 Femtoliter	Standard Deviation 7.76
DTG 50 mg BID	Change From Baseline in Mean Corpuscle Volume	Week 60; n=5, 12	1.4 Femtoliter	Standard Deviation 7.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 40; n=8, 12	-0.7 Femtoliter	Standard Deviation 11.41
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 16; n=12, 16	-2.2 Femtoliter	Standard Deviation 8.85
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Day 28; n=13, 16	0.3 Femtoliter	Standard Deviation 3.82
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Baseline; n=14, 16	97.8 Femtoliter	Standard Deviation 9.28
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 60; n=5, 12	-1.2 Femtoliter	Standard Deviation 11.82
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Day 8; n=14, 15	0.3 Femtoliter	Standard Deviation 1.71
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 24; n=11, 15	-2.0 Femtoliter	Standard Deviation 10.36
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 8; n=11, 16	-0.3 Femtoliter	Standard Deviation 6.02
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 48; n=8, 13	-1.0 Femtoliter	Standard Deviation 11.73
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 32; n=11, 13	-2.4 Femtoliter	Standard Deviation 10.87
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 72; n=3, 4	2.3 Femtoliter	Standard Deviation 14.1
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 84; n=0, 1	18.0 Femtoliter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Mean Corpuscle Volume	Week 12; n=12, 14	-1.5 Femtoliter	Standard Deviation 7.39

Secondary

Change From Baseline in Red Blood Cell Count

Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Day 8; n=14, 15	0.00 Trillion cells per liter	Standard Deviation 0.254
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Day 28; n=13, 16	-0.08 Trillion cells per liter	Standard Deviation 0.309
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 48; n=8, 13	-0.00 Trillion cells per liter	Standard Deviation 0.334
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 60; n=5, 12	-0.06 Trillion cells per liter	Standard Deviation 0.428
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 8; n=11, 16	-0.14 Trillion cells per liter	Standard Deviation 0.434
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 12; n=12, 14	-0.05 Trillion cells per liter	Standard Deviation 0.493
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 16; n=12, 16	-0.03 Trillion cells per liter	Standard Deviation 0.529
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 24; n=11, 15	0.02 Trillion cells per liter	Standard Deviation 0.464
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 32; n=11, 13	-0.04 Trillion cells per liter	Standard Deviation 0.467
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 40; n=8, 12	-0.08 Trillion cells per liter	Standard Deviation 0.392
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Week 72; n=3, 4	-0.20 Trillion cells per liter	Standard Deviation 0.173
DTG 50 mg BID	Change From Baseline in Red Blood Cell Count	Baseline; n=14, 16	4.09 Trillion cells per liter	Standard Deviation 0.55
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 72; n=3, 4	0.25 Trillion cells per liter	Standard Deviation 0.759
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 24; n=11, 15	0.18 Trillion cells per liter	Standard Deviation 0.514
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 84; n=0, 1	-0.60 Trillion cells per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Day 28; n=13, 16	-0.06 Trillion cells per liter	Standard Deviation 0.318
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 32; n=11, 13	0.18 Trillion cells per liter	Standard Deviation 0.504
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 48; n=8, 13	0.15 Trillion cells per liter	Standard Deviation 0.625
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Day 8; n=14, 15	-0.04 Trillion cells per liter	Standard Deviation 0.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 40; n=8, 12	0.09 Trillion cells per liter	Standard Deviation 0.658
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 8; n=11, 16	0.12 Trillion cells per liter	Standard Deviation 0.435
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 60; n=5, 12	0.28 Trillion cells per liter	Standard Deviation 0.625
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 12; n=12, 14	0.15 Trillion cells per liter	Standard Deviation 0.477
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Baseline; n=14, 16	4.09 Trillion cells per liter	Standard Deviation 0.731
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Red Blood Cell Count	Week 16; n=12, 16	0.13 Trillion cells per liter	Standard Deviation 0.478

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline and Weeks 24 and 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Baseline; n=14, 16	120.4 millimeters of mercury	Standard Deviation 15.6
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 24; n=11, 15	2.0 millimeters of mercury	Standard Deviation 12.28
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 48; n=6, 12	-0.7 millimeters of mercury	Standard Deviation 19.5
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Baseline; n=14, 16	78.9 millimeters of mercury	Standard Deviation 12.51
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 24; n=11, 15	-0.5 millimeters of mercury	Standard Deviation 9.49
DTG 50 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 48; n=6, 12	-1.2 millimeters of mercury	Standard Deviation 13.92
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 24; n=11, 15	-1.2 millimeters of mercury	Standard Deviation 10.35
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Baseline; n=14, 16	113.4 millimeters of mercury	Standard Deviation 9.99
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Baseline; n=14, 16	75.1 millimeters of mercury	Standard Deviation 8.46
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 24; n=11, 15	2.8 millimeters of mercury	Standard Deviation 13.82
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 48; n=6, 12	-3.2 millimeters of mercury	Standard Deviation 8.78
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 48; n=6, 12	3.1 millimeters of mercury	Standard Deviation 12.57

Secondary

Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels

Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.

Time frame: Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Day 28; n=13, 16	-0.2 Micromoles per liter	Standard Deviation 6.19
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Baseline; n=14, 16	86.94 Micromoles per liter	Standard Deviation 18.971
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 24; n=11, 15	0.2 Micromoles per liter	Standard Deviation 2.89
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Day 8; n=13, 15	10.96 Micromoles per liter	Standard Deviation 24.505
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 16; n=10, 16	8.22 Micromoles per liter	Standard Deviation 13.464
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Day 28; n=13, 16	12.72 Micromoles per liter	Standard Deviation 19.697
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 32; n=11, 14	-0.4 Micromoles per liter	Standard Deviation 3.2
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 8; n=11, 16	12.15 Micromoles per liter	Standard Deviation 8.57
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 8; n=11, 16	0.0 Micromoles per liter	Standard Deviation 4.2
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 12; n=12, 14	6.86 Micromoles per liter	Standard Deviation 9.153
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 40; n=8, 12	0.0 Micromoles per liter	Standard Deviation 3.7
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 24; n=11, 15	1.63 Micromoles per liter	Standard Deviation 11.098
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Day 8; n=13, 15	0.8 Micromoles per liter	Standard Deviation 6.81
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 32; n=11, 14	0.98 Micromoles per liter	Standard Deviation 7.441
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 48; n=8, 13	-0.8 Micromoles per liter	Standard Deviation 4.13
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 40; n=8, 12	3.58 Micromoles per liter	Standard Deviation 10.788
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 12; n=12, 14	0.5 Micromoles per liter	Standard Deviation 4.76
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 48; n=8, 13	4.21 Micromoles per liter	Standard Deviation 19.45
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 60; n=5, 12	-2.4 Micromoles per liter	Standard Deviation 2.61
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 60; n=5, 12	4.96 Micromoles per liter	Standard Deviation 5.56
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Baseline; n=14, 16	10.0 Micromoles per liter	Standard Deviation 4.51
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 72; n=3, 4	0.93 Micromoles per liter	Standard Deviation 8.529
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 72; n=3, 4	-1.3 Micromoles per liter	Standard Deviation 4.16
DTG 50 mg BID	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 16; n=10, 16	0.6 Micromoles per liter	Standard Deviation 3.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 72; n=3, 4	13.25 Micromoles per liter	Standard Deviation 16.957
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 84; n=0, 1	1.80 Micromoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 72; n=3, 4	9.5 Micromoles per liter	Standard Deviation 16.36
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 12; n=12, 14	9.85 Micromoles per liter	Standard Deviation 13.274
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Baseline; n=14, 16	7.5 Micromoles per liter	Standard Deviation 3.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Day 8; n=13, 15	-1.1 Micromoles per liter	Standard Deviation 2.12
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Day 28; n=13, 16	2.1 Micromoles per liter	Standard Deviation 9.78
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 8; n=11, 16	3.1 Micromoles per liter	Standard Deviation 13.76
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 12; n=12, 14	-0.6 Micromoles per liter	Standard Deviation 2.14
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 16; n=10, 16	1.9 Micromoles per liter	Standard Deviation 10.89
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 24; n=11, 15	2.1 Micromoles per liter	Standard Deviation 8.19
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 32; n=11, 14	2.3 Micromoles per liter	Standard Deviation 10.16
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 40; n=8, 12	3.3 Micromoles per liter	Standard Deviation 12.43
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 48; n=8, 13	3.2 Micromoles per liter	Standard Deviation 12.18
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 60; n=5, 12	2.3 Micromoles per liter	Standard Deviation 11.63
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	T. Bil.; Week 84; n=0, 1	2.0 Micromoles per liter	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Baseline; n=14, 16	88.96 Micromoles per liter	Standard Deviation 24.013
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Day 8; n=13, 15	0.11 Micromoles per liter	Standard Deviation 14.873
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Day 28; n=13, 16	13.58 Micromoles per liter	Standard Deviation 21.03
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 8; n=11, 16	15.79 Micromoles per liter	Standard Deviation 19.574
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 16; n=10, 16	7.68 Micromoles per liter	Standard Deviation 13.031
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 24; n=11, 15	13.31 Micromoles per liter	Standard Deviation 17.347
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 32; n=11, 14	15.96 Micromoles per liter	Standard Deviation 11.902
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 40; n=8, 12	12.94 Micromoles per liter	Standard Deviation 13.87
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 48; n=8, 13	12.85 Micromoles per liter	Standard Deviation 9.128
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels	Creatinine; Week 60; n=5, 12	11.72 Micromoles per liter	Standard Deviation 15.82

Secondary

Cmax of DTG

The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.

Time frame: Day 8, Day 28, and Week 24

Population: PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
DTG 50 mg BID	Cmax of DTG	4.14 Micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 32.6

Secondary

Mean Change From Baseline in Plasma HIV-1 RNA Over Time

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84

Population: ITT-E Population. The Observed Case dataset, in which only the data that are available at the particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 32, n=11, 14	-1.31 Log10 c/mL	Standard Deviation 1.059
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 72, n=3, 4	-2.08 Log10 c/mL	Standard Deviation 1.311
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Day 28, n=13, 16	-1.87 Log10 c/mL	Standard Deviation 0.898
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 40, n=7, 12	-1.48 Log10 c/mL	Standard Deviation 1.445
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Baseline, n=14, 16	4.02 Log10 c/mL	Standard Deviation 0.94
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 24, n=11, 15	-1.38 Log10 c/mL	Standard Deviation 1.151
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 8, n=11, 16	-1.89 Log10 c/mL	Standard Deviation 0.89
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 48, n=8, 13	-1.34 Log10 c/mL	Standard Deviation 1.235
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 12, n=12, 14	-1.54 Log10 c/mL	Standard Deviation 1.022
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Day 8, n=14, 16	-1.07 Log10 c/mL	Standard Deviation 0.683
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 16, n=12, 16	-1.48 Log10 c/mL	Standard Deviation 1.101
DTG 50 mg BID	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 60, n=5, 12	-1.91 Log10 c/mL	Standard Deviation 1.4
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Baseline, n=14, 16	4.42 Log10 c/mL	Standard Deviation 0.76
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 16, n=12, 16	-2.24 Log10 c/mL	Standard Deviation 1.18
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Day 8, n=14, 16	-0.03 Log10 c/mL	Standard Deviation 0.262
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 24, n=11, 15	-2.53 Log10 c/mL	Standard Deviation 1.033
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 32, n=11, 14	-2.62 Log10 c/mL	Standard Deviation 0.931
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 40, n=7, 12	-2.70 Log10 c/mL	Standard Deviation 0.843
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 48, n=8, 13	-2.77 Log10 c/mL	Standard Deviation 0.881
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 60, n=5, 12	-2.71 Log10 c/mL	Standard Deviation 0.863
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 72, n=3, 4	-3.31 Log10 c/mL	Standard Deviation 0.968
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 84, n=0, 1	-3.75 Log10 c/mL	—
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Day 28, n=13, 16	-2.12 Log10 c/mL	Standard Deviation 1.111
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 8, n=11, 16	-2.32 Log10 c/mL	Standard Deviation 1.112
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Mean Change From Baseline in Plasma HIV-1 RNA Over Time	Week 12, n=12, 14	-2.02 Log10 c/mL	Standard Deviation 1.245

Secondary

Median Change From Baseline in CD4+ Cell Counts Over Time

Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84

Population: ITT-E Population. Observed dataset was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 40, n=8, 12	90.5 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 16, n=12, 16	76.5 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 48, n=8, 13	115.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Day 28, n=13, 16	14.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 24, n=11, 15	39.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 12, n=12, 14	49.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Day 8, n=14, 15	7.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 60, n=5, 12	170.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 32, n=11, 14	48.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 72, n=3, 4	163.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 8, n=11, 16	34.0 Cells per cubic millimeters
DTG 50 mg BID	Median Change From Baseline in CD4+ Cell Counts Over Time	Baseline, n=14, 16	163.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 72, n=3, 4	174.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 84, n=0, 1	269.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Baseline, n=14, 16	90.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Day 8, n=14, 15	0.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Day 28, n=13, 16	68.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 16, n=12, 16	70.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 24, n=11, 15	117.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 32, n=11, 14	135.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 40, n=8, 12	125.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 48, n=8, 13	156.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 8, n=11, 16	87.5 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 12, n=12, 14	79.0 Cells per cubic millimeters
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD4+ Cell Counts Over Time	Week 60, n=5, 12	146.0 Cells per cubic millimeters

Secondary

Median Change From Baseline in CD8+ Cell Counts Over Time

Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Time frame: Baseline; Day 28; Weeks 12, 24, and 48

Arm	Measure	Group	Value (MEDIAN)
DTG 50 mg BID	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 12, n=11, 14	151.0 Cells per cubic millimeter
DTG 50 mg BID	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 48, n=6, 12	88.0 Cells per cubic millimeter
DTG 50 mg BID	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 24, n=11, 15	79.0 Cells per cubic millimeter
DTG 50 mg BID	Median Change From Baseline in CD8+ Cell Counts Over Time	Baseline, n=14, 16	896.0 Cells per cubic millimeter
DTG 50 mg BID	Median Change From Baseline in CD8+ Cell Counts Over Time	Day 28, n=13, 16	227.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD8+ Cell Counts Over Time	Baseline, n=14, 16	808.5 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD8+ Cell Counts Over Time	Day 28, n=13, 16	177.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 12, n=11, 14	288.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 24, n=11, 15	543.0 Cells per cubic millimeter
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Median Change From Baseline in CD8+ Cell Counts Over Time	Week 48, n=6, 12	124.0 Cells per cubic millimeter

Secondary

Number of Participants Who Discontinued Study Treatment Due to AEs

The number of participants who permanently discontinued study treatment due to AEs is presented.

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

Population: Safety Population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants Who Discontinued Study Treatment Due to AEs	2 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants Who Discontinued Study Treatment Due to AEs	0 Participants

Secondary

Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 4	2 Participants
DTG 50 mg BID	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 3	2 Participants
DTG 50 mg BID	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 1	0 Participants
DTG 50 mg BID	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 2	7 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 2	6 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 3	3 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 4	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade	Grade 1	4 Participants

Secondary

Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.

Time frame: Up to Week 24

Population: Safety Population. Only those participants with data available at the specified time point was analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings	1 Participants

Secondary

Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time

Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level \<400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48

Population: ITT-E Population. The Snapshot dataset was used for analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 16	7 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Baseline	2 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 8	7 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 32	6 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 40	5 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 48	6 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Day 8	4 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Day 28	9 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 12	7 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 24	6 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 8	13 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Baseline	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Day 28	12 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 48	10 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 12	10 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 24	11 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Day 8	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 32	10 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 16	12 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time	Week 40	10 Participants

Secondary

Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time

Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level \<50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.

Time frame: Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48

Population: ITT-E Population. The Snapshot dataset was used for analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Baseline	0 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Day 8	1 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Day 28	6 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 12	6 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 16	5 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 24	6 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 32	4 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 40	4 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 48	3 Participants
DTG 50 mg BID	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 8	5 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 48	9 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Baseline	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 32	9 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Day 8	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 8	9 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 40	7 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 12	8 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 16	8 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Day 28	6 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time	Week 24	8 Participants

Secondary

Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance

For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of 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 was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>1 log10 copies/mL above the nadir value, where nadir is \>=400 copies/mL.

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

Population: PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance	4-<8 fold increase in DTG FC	0 Participants
DTG 50 mg BID	Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance	>=8 fold increase in DTG FC	4 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance	4-<8 fold increase in DTG FC	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance	>=8 fold increase in DTG FC	0 Participants

Secondary

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance

For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>1 log10 copies/mL above the nadir value, where nadir is \>=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	N155N/H	1 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	Any integrase mutation	4 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	L74L/M	1 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	T97A	2 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	E138E/K	1 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	E138K	1 Participants
DTG 50 mg BID	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	S147G	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	N155N/H	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	E138E/K	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	Any integrase mutation	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	S147G	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	L74L/M	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	E138K	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance	T97A	1 Participants

Secondary

Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])

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

Time frame: From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)

Population: ITT-E Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class A, B, or C to Death	2 Participants
DTG 50 mg BID	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class B to CDC Class C	0 Participants
DTG 50 mg BID	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class C to new CDC Class C	0 Participants
DTG 50 mg BID	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class A to CDC Class C	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class C to new CDC Class C	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class A, B, or C to Death	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class A to CDC Class C	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])	From CDC Class B to CDC Class C	0 Participants

Secondary

Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade

Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 1	5 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 2	5 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 3	0 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 4	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 4	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 1	4 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 3	4 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade	Grade 2	5 Participants

Secondary

Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade

Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).

Time frame: From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 1	2 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 2	2 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 3	0 Participants
DTG 50 mg BID	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 4	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 4	0 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 1	3 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 3	1 Participants
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade	Grade 2	5 Participants

Secondary

Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24

Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.

Time frame: Day 8, Day 28, and Week 24

Population: PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
DTG 50 mg BID	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Week 24 C0, n=10, 14	1.864 µg/mL	Geometric Coefficient of Variation 110
DTG 50 mg BID	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Day 8 C0, n=10, 0	3.043 µg/mL	Geometric Coefficient of Variation 44
DTG 50 mg BID	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Day 28 C0, n=11, 16	1.393 µg/mL	Geometric Coefficient of Variation 189
DTG 50 mg BID	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	C0_avg, n=13, 16	1.820 µg/mL	Geometric Coefficient of Variation 188
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Week 24 C0, n=10, 14	2.201 µg/mL	Geometric Coefficient of Variation 145
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	C0_avg, n=13, 16	2.307 µg/mL	Geometric Coefficient of Variation 76
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase	Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24	Day 28 C0, n=11, 16	2.154 µg/mL	Geometric Coefficient of Variation 81

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026

Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8

Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time

Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time

Absolute Values in Plasma HIV-1 RNA Over Time

AUC(0-tau) of DTG

Change From Baseline in Albumin Level

Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count

Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen

Change From Baseline in Creatinine Clearance

Change From Baseline in Heart Rate

Change From Baseline in Hematocrit Level

Change From Baseline in Hemoglobin Level

Change From Baseline in Lipase Levels

Change From Baseline in Mean Corpuscle Volume

Change From Baseline in Red Blood Cell Count

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels

Cmax of DTG

Mean Change From Baseline in Plasma HIV-1 RNA Over Time

Median Change From Baseline in CD4+ Cell Counts Over Time

Median Change From Baseline in CD8+ Cell Counts Over Time

Number of Participants Who Discontinued Study Treatment Due to AEs

Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade

Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time

Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time

Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance

Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])

Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade

Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade

Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24