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A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects (ING112276)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by ViiV Healthcare.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00951015
First received: July 30, 2009
Last updated: December 19, 2013
Last verified: October 2013
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: efavirenz

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants (par.) were randomized (ran) to receive Dolutegravir (DTG) (3 dose groups) or Efavirenz for 96 weeks. At Week 96, par. ran. to any dose of DTG entered an open-label phase and continued to receive DTG at the selected dose of 50 milligrams. A total of 208 par. were ran., and 205 received at least one dose of study medication.

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Participant Flow:   Overall Study
    DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD
STARTED   53   51   51   50 
Ongoing   47   45   46   8 
COMPLETED   0   0   0   32 
NOT COMPLETED   53   51   51   18 
Adverse Event                1                1                2                5 
Lack of Efficacy                1                1                0                0 
Protocol Violation                1                1                1                0 
Protocol-Defined Stopping Criteria                0                0                0                1 
Lost to Follow-up                0                2                1                2 
Withdrawal by Subject                3                1                1                2 
Ongoing                47                45                46                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Total Total of all reporting groups

Baseline Measures
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   51   51   50   205 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2  (9.25)   37.0  (9.79)   37.0  (8.89)   40.7  (11.19)   37.2  (10.00) 
Gender 
[Units: Participants]
         
Female   11   5   6   6   28 
Male   42   46   45   44   177 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage (HER)   7   6   8   4   25 
American Indian or Alaska Native   1   3   4   2   10 
Japanese/East Asian HER/South East Asian HER   0   0   0   1   1 
Native Hawaiian or other Pacific Islander   3   0   0   0   3 
White   41   42   38   43   164 
African American/African HER & White   0   0   1   0   1 
Asian & White   1   0   0   0   1 


  Outcome Measures
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1.  Primary:   Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16   [ Time Frame: Week 16 ]

Measure Type Primary
Measure Title Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).
Time Frame Week 16  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16 
[Units: Participants]
 51   47   46   30 

No statistical analysis provided for Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16



2.  Secondary:   Viral Change Over the Initial 2 Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

Measure Type Secondary
Measure Title Viral Change Over the Initial 2 Weeks of Treatment
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline.
Time Frame Baseline and Week 2  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Only those participants available at the specified time point were analyzed.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   50   50   48 
Viral Change Over the Initial 2 Weeks of Treatment 
[Units: Log10 c/mL]
Mean (Standard Deviation)
 -2.387  (0.4595)   -2.365  (0.5458)   -2.392  (0.4241)   -1.930  (0.4312) 

No statistical analysis provided for Viral Change Over the Initial 2 Weeks of Treatment



3.  Secondary:   Change From Baseline in HIV-1 RNA at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at the Indicated Time Points
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, 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 ITT-E Population.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Change From Baseline in HIV-1 RNA at the Indicated Time Points 
[Units: Log10 c/mL]
Mean (Standard Deviation)
       
Week 1, n=53, 50, 48, 50   -1.815  (0.3999)   -1.773  (0.4650)   -1.738  (0.3840)   -1.562  (0.4158) 
Week 2, n=53, 50, 50, 48   -2.387  (0.4595)   -2.365  (0.5458)   -2.392  (0.4241)   -1.930  (0.4312) 
Week 4, n=53, 50, 50, 45   -2.629  (0.5863)   -2.583  (0.6337)   -2.713  (0.5471)   -2.162  (0.5400) 
Week 8, n=52, 50, 49, 45   -2.657  (0.6980)   -2.666  (0.6667)   -2.848  (0.6556)   -2.450  (0.5989) 
Week 12, n=53, 49, 49, 45   -2.685  (0.6831)   -2.671  (0.6850)   -2.860  (0.6772)   -2.603  (0.5869) 
Week 16, n=52, 49, 49, 45   -2.718  (0.6593)   -2.668  (0.6826)   -2.859  (0.6876)   -2.698  (0.6715) 
Week 20, n=52, 48, 49, 44   -2.701  (0.6423)   -2.662  (0.6908)   -2.869  (0.6896)   -2.745  (0.6602) 
Week 24, n=52, 49, 48, 45   -2.700  (0.6261)   -2.657  (0.6969)   -2.853  (0.6889)   -2.773  (0.7026) 
Week 32, n=52, 49, 47, 45   -2.717  (0.6588)   -2.658  (0.6991)   -2.855  (0.6963)   -2.772  (0.7021) 
Week 40, n=51, 48, 47, 44   -2.647  (0.7039)   -2.665  (0.7051)   -2.855  (0.6934)   -2.795  (0.7169) 
Week 48, n=51, 48, 48, 45   -2.723  (0.6519)   -2.667  (0.6934)   -2.850  (0.6849)   -2.711  (0.7765) 
Week 60, n=50, 48, 48, 44   -2.741  (0.6444)   -2.675  (0.7012)   -2.825  (0.7458)   -2.765  (0.7035) 
Week 72, n=51, 47, 48, 44   -2.742  (0.6453)   -2.622  (0.8052)   -2.860  (0.6930)   -2.757  (0.7094) 
Week 84, n=51, 47, 47, 43   -2.725  (0.6506)   -2.670  (0.7064)   -2.855  (0.6923)   -2.743  (0.7321) 
Week 96, n=48, 44, 46, 39   -2.728  (0.6494)   -2.680  (0.7116)   -2.854  (0.7061)   -2.807  (0.7238) 

No statistical analysis provided for Change From Baseline in HIV-1 RNA at the Indicated Time Points



4.  Secondary:   Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Measure Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, 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 ITT-E Population.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points 
[Units: Cells per cubic millimeter]
Median (Inter-Quartile Range)
       
Week 1, n=53, 50, 48, 50   85.0 
 (18.0 to 134.0) 
 94.5 
 (40.0 to 160.0) 
 75.5 
 (18.5 to 129.5) 
 42.5 
 (-23.0 to 111.0) 
Week 2, n=53, 50, 50, 47   75.0 
 (37.0 to 124.0) 
 79.0 
 (27.0 to 138.0) 
 99.5 
 (53.0 to 160.0) 
 55.0 
 (-10.0 to 132.0) 
Week 4, n=53, 50, 50, 45   75.0 
 (34.0 to 151.0) 
 89.0 
 (36.0 to 165.0) 
 110.0 
 (46.0 to 170.0) 
 89.0 
 (30.0 to 165.0) 
Week 8, n=52, 50, 49, 44   118.5 
 (65.5 to 210.5) 
 156.5 
 (93.0 to 226.0) 
 129.0 
 (105.0 to 201.0) 
 104.5 
 (34.5 to 240.5) 
Week 12, n=53, 48, 48, 45   139.0 
 (96.0 to 284.0) 
 137.5 
 (61.0 to 250.0) 
 171.5 
 (107.5 to 269.0) 
 127.0 
 (58.0 to 186.0) 
Week 16, n=52, 49, 49, 44   153.0 
 (95.0 to 276.0) 
 176.0 
 (86.0 to 227.0) 
 160.0 
 (94.0 to 227.0) 
 115.5 
 (65.5 to 226.0) 
Week 20, n=52, 48, 49, 44   163.5 
 (79.5 to 288.5) 
 200.0 
 (103.0 to 316.5) 
 139.0 
 (64.0 to 238.0) 
 136.0 
 (54.5 to 215.5) 
Week 24, n=51, 49, 47, 44   159.0 
 (97.0 to 233.0) 
 206.0 
 (102.0 to 289.0) 
 167.0 
 (125.0 to 268.0) 
 109.5 
 (66.0 to 229.0) 
Week 32, n=50, 48, 47, 44   221.5 
 (94.0 to 300.0) 
 195.5 
 (109.0 to 294.0) 
 203.0 
 (125.0 to 282.0) 
 146.5 
 (82.5 to 223.5) 
Week 40, n=50, 48, 47, 44   205.0 
 (136.0 to 364.0) 
 204.5 
 (157.5 to 346.5) 
 224.0 
 (123.0 to 322.0) 
 171.5 
 (123.0 to 268.0) 
Week 48, n=51, 47, 47, 45   204.0 
 (127.0 to 384.0) 
 249.0 
 (143.0 to 416.0) 
 223.0 
 (141.0 to 292.0) 
 174.0 
 (91.0 to 292.0) 
Week 60, n=51, 48, 47, 43   265.0 
 (173.0 to 365.0) 
 278.0 
 (198.5 to 369.5) 
 229.0 
 (166.0 to 306.0) 
 221.0 
 (153.0 to 355.0) 
Week 72, n=51, 47, 48, 44   236.0 
 (177.0 to 351.0) 
 285.0 
 (186.0 to 427.0) 
 220.0 
 (146.0 to 373.0) 
 195.0 
 (144.0 to 334.5) 
Week 84, n=51, 47, 46, 42   292.0 
 (222.0 to 408.0) 
 313.0 
 (244.0 to 366.0) 
 280.0 
 (197.0 to 379.0) 
 296.5 
 (187.0 to 400.0) 
Week 96, n=48, 44, 46, 39   335.0 
 (253.5 to 478.5) 
 391.5 
 (243.0 to 527.0) 
 326.0 
 (236.0 to 451.0) 
 301.0 
 (204.0 to 445.0) 

No statistical analysis provided for Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points



5.  Secondary:   Number of Participants With New HIV-associated Conditions of the Indicated Class   [ Time Frame: From Baseline up to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With New HIV-associated Conditions of the Indicated Class
Measure Description HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.
Time Frame From Baseline up to Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With New HIV-associated Conditions of the Indicated Class 
[Units: Participants]
       
Category B   2   0   1   1 
Category C   0   0   1   0 
Death   1   0   0   0 

No statistical analysis provided for Number of Participants With New HIV-associated Conditions of the Indicated Class



6.  Secondary:   Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)   [ Time Frame: From Baseline up to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
Measure Description Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.
Time Frame From Baseline up to Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death) 
[Units: Participants]
       
CAT A at Baseline to a CAT C event   0   0   0   0 
CAT B at Baseline to a CAT C event   0   0   1   0 
CAT C at Baseline to a new CAT C event   0   0   0   0 
CAT A, B, or C at Baseline to death   1   0   0   0 

No statistical analysis provided for Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)



7.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Plasma HIV-1 RNA <50 c/mL
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Time Frame Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With Plasma HIV-1 RNA <50 c/mL 
[Units: Participants]
       
Baseline   0   0   0   0 
Week 1   6   4   4   3 
Week 2   22   19   11   6 
Week 4   37   35   31   9 
Week 8   46   45   43   18 
Week 12   50   46   45   25 
Week 16   51   46   47   29 
Week 20   51   47   47   38 
Week 24   51   46   47   41 
Week 32   50   45   46   43 
Week 40   49   45   46   42 
Week 48   48   45   46   40 
Week 60   48   44   46   41 
Week 72   48   44   45   40 
Week 84   47   43   46   38 
Week 96   42   40   45   36 

No statistical analysis provided for Number of Participants With Plasma HIV-1 RNA <50 c/mL



8.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Plasma HIV-1 RNA <400 c/mL
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Time Frame Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With Plasma HIV-1 RNA <400 c/mL 
[Units: Participants]
       
Baseline   0   0   0   0 
Week 1   25   20   16   15 
Week 2   45   45   41   23 
Week 4   52   49   48   32 
Week 8   52   49   49   41 
Week 12   52   49   49   45 
Week 16   52   48   49   45 
Week 20   52   48   49   45 
Week 24   52   47   48   45 
Week 32   52   47   48   45 
Week 40   50   47   48   45 
Week 48   50   47   48   44 
Week 60   50   46   48   44 
Week 72   50   46   47   43 
Week 84   50   45   47   42 
Week 96   46   43   46   39 

No statistical analysis provided for Number of Participants With Plasma HIV-1 RNA <400 c/mL



9.  Secondary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

Measure Type Secondary
Measure Title Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)
Measure Description 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. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.
Time Frame From Baseline up to Week 96/Early Withdrawal  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE) 
[Units: Participants]
       
Any AE   50   46   46   46 
Any SAE   5   5   7   7 

No statistical analysis provided for Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)



10.  Secondary:   Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Measure Description Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities 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 Baseline up to Week 96/Early Withdrawal  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 53   51   51   50 
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities 
[Units: Participants]
       
Alanine amino transferase   7   11   3   19 
Cholesterol   18   16   13   24 
Creatinine kinase   17   6   7   5 
Lipase   11   13   11   9 
Triglycerides   0   1   2   1 
Alkaline phosphatase   1   0   1   10 
Amylase   2   3   1   4 
Aspartate amino transferase   12   8   6   9 
Carbon dioxide content/bicarbonate   28   24   23   30 
Creatinine   0   4   0   0 
Hypercalcemia   0   0   0   1 
Hyperglycaemia   16   15   17   17 
Hyperkalemia   0   0   1   1 
Hypernatremia   1   1   1   0 
Hypocalcemia   4   5   5   8 
Hypoglycaemia   3   3   5   4 
Hypokalemia   4   1   3   3 
Hyponatremia   6   12   7   13 
Low-density lipoprotein cholesterol   14   15   11   20 
Magnesium   7   6   5   4 
Phosphate, inorganic   9   15   14   11 
Total bilirubin   3   4   3   0 
Activated partial thromboplastin time   7   12   6   5 
Hemoglobin   0   1   0   1 
International normalized ratio   6   9   6   5 
Platelet count   1   4   1   1 
Prothrombin time   7   8   7   4 
Total neutrophils   9   7   6   10 
White blood cell count   1   1   1   1 

No statistical analysis provided for Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities



11.  Secondary:   Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
Measure Description 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 Week 4, 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 without evidence of prior suppression to <400copies/mL 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 >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
Time Frame From Baseline up to Week 96/Early Withdrawal  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 2   1   0   1 
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance 
[Units: Participants]
       
A23A/V   1   0      0 
S255N   1   0      0 

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance



12.  Secondary:   Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
Measure Description 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 Week 4, 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 without evidence of prior suppression to <400copies/mL 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 >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
Time Frame From Baseline up to Week 96/Early Withdrawal  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 2   1   0   1 
Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance 
[Units: Participants]
 1   0      0 

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance



13.  Secondary:   Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
Measure Description 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. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, 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 without evidence of prior suppression to <400copies/mL 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 >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
Time Frame From Baseline up to Week 96/Early Withdrawal  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data, excluding participants who were not protocol-defined virologic failures.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 2   1   0   0 
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance 
[Units: Participants]
       
<1 fold   0   1       
1-<2 fold   2   0       
2-<4 fold   0   0       
4-<8 fold   0   0       
>=8 fold   0   0       

No statistical analysis provided for Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance



14.  Secondary:   Plasma DTG Concentration   [ Time Frame: Week 2, Week 12, and Week 24 ]

Measure Type Secondary
Measure Title Plasma DTG Concentration
Measure Description Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters.
Time Frame Week 2, Week 12, and Week 24  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, 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 Summary Population.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 48   46   46   0 
Plasma DTG Concentration 
[Units: Micrograms per milliliter (µg/mL)]
Mean (Standard Deviation)
       
Week 2, Pre-dose, n=46, 44, 43, 0   0.3580  (0.18321)   0.6779  (0.44085)   1.4044  (0.88041)    
Week 2, 2-4 hours post-dose, n=31, 29, 29, 0   1.0121  (0.28125)   1.9716  (0.71890)   3.8414  (1.87405)    
Week 12, Pre-dose, n= 46, 45, 44, 0   0.3648  (0.16791)   0.5759  (0.32645)   1.4169  (1.00152)    
Week 12, 2-4 hours post-dose, n=48, 45, 45, 0   1.0374  (0.27517)   1.7907  (0.70953)   3.6056  (1.33862)    
Week 24, Pre-dose, n=45, 44, 44, 0   0.3766  (0.23399)   0.6636  (0.50767)   1.4534  (0.94283)    
Week 24, 2-4 hours post-dose, n=45, 45, 45, 0   1.0113  (0.34083)   1.9021  (0.79430)   3.5397  (1.36538)    

No statistical analysis provided for Plasma DTG Concentration



15.  Secondary:   AUC(0-tau) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

Measure Type Secondary
Measure Title AUC(0-tau) of DTG
Measure Description The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Summary Population. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 15   15   15   0 
AUC(0-tau) of DTG 
[Units: Hours*µg/mL]
Geometric Mean (Geometric Coefficient of Variation)
 16.0 
 (40%) 
 23.1 
 (48%) 
 48.1 
 (40%) 
  

No statistical analysis provided for AUC(0-tau) of DTG



16.  Secondary:   Cmax, Cmin, and Ctau of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

Measure Type Secondary
Measure Title Cmax, Cmin, and Ctau of DTG
Measure Description The maximal concentration (Cmax), minimal concentration (Cmax), and concentration at the end of dosing interval (Ctau) of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Summary Population. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 15   15   15   0 
Cmax, Cmin, and Ctau of DTG 
[Units: µg/mL]
Geometric Mean (Geometric Coefficient of Variation)
       
Cmax   1.10 
 (37%) 
 1.71 
 (43%) 
 3.40 
 (27%) 
  
Cmin   0.33 
 (64%) 
 0.44 
 (68%) 
 0.94 
 (74%) 
  
Ctau   0.37 
 (55%) 
 0.45 
 (71%) 
 1.05 
 (72%) 
  

No statistical analysis provided for Cmax, Cmin, and Ctau of DTG



17.  Secondary:   C0 and C0 Avg of DTG   [ Time Frame: Week 2, Week 12, and Week 24 ]

Measure Type Secondary
Measure Title C0 and C0 Avg of DTG
Measure Description The plasma DTG pre-dose concentration (C0) of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame Week 2, Week 12, and Week 24  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, 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 Summary Population.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 49   46   46   0 
C0 and C0 Avg of DTG 
[Units: µg/mL]
Geometric Mean (Geometric Coefficient of Variation)
       
C0, Week 2, n=46, 44, 43, 0   0.31 
 (58%) 
 0.57 
 (62%) 
 1.20 
 (61%) 
  
C0, Week 12, n=46, 45, 44, 0   0.33 
 (49%) 
 0.47 
 (77%) 
 1.13 
 (95%) 
  
C0, Week 24, n=45, 44, 44, 0   0.33 
 (67%) 
 0.57 
 (74%) 
 1.20 
 (74%) 
  
C0 avg, n=48, 46, 46, 0   0.34 
 (49%) 
 0.56 
 (61%) 
 1.25 
 (55%) 
  

No statistical analysis provided for C0 and C0 Avg of DTG



18.  Secondary:   Time to Maximal Drug Concentration (Tmax) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

Measure Type Secondary
Measure Title Time to Maximal Drug Concentration (Tmax) of DTG
Measure Description tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Summary Population. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 15   15   15   0 
Time to Maximal Drug Concentration (Tmax) of DTG 
[Units: Hours]
Median (Full Range)
 2.0 
 (2.0 to 4.0) 
 2.0 
 (2.0 to 8.0) 
 2.0 
 (1.9 to 4.0) 
  

No statistical analysis provided for Time to Maximal Drug Concentration (Tmax) of DTG



19.  Secondary:   Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
Measure Description Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame Week 2  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Overall DTG All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD   Overall DTG 
Participants Analyzed 
[Units: Participants]
 15   15   15   0   45 
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters 
[Units: Pearson's correlation coefficient]
         
AUC(0-tau)   0.426   -0.018   -0.258      -0.086 
Cmax   0.452   -0.051   -0.150      -0.055 
Ctau   0.273   -0.100   -0.263      -0.129 

No statistical analysis provided for Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters



20.  Secondary:   Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
Measure Description Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Time Frame Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Overall DTG All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD   Overall DTG 
Participants Analyzed 
[Units: Participants]
 50   46   46   0   142 
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters 
[Units: Pearson's correlation coefficient]
         
AUC(0-tau), n=13, 14, 15, 0   -0.100   0.379   0.008      -0.005 
Cmax, n=13, 14, 15, 0   -0.047   0.332   0.234      0.037 
C0avg, n=43, 40, 42, 0   -0.009   -0.013   0.206      -0.011 
Ctau, n=13, 14, 15, 0   -0.289   0.299   -0.074      -0.055 

No statistical analysis provided for Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters



21.  Secondary:   Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Measure Description Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.

Reporting Groups
  Description
Overall DTG All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)

Measured Values
   Overall DTG 
Participants Analyzed 
[Units: Participants]
 142 
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters 
[Units: Pearson's correlation coefficient]
 
AUC(0-tau) versus AE occurrence, n=45   0.114 
AUC(0-tau) versus maximum AE intensity, n=45   0.171 
AUC(0-tau) versus ALT, n=45   -0.196 
AUC(0-tau) versus CFB in ALT, n=45   -0.201 
AUC(0-tau) versus total bilirubin, n=45   0.364 
AUC(0-tau) versus CFB in total bilirubin, n=45   0.147 
AUC(0-tau) versus creatine kinase, n=45   -0.168 
AUC(0-tau) versus CFB in creatine kinase, n=45   -0.145 
AUC(0-tau) vs Triglycerides, n=45   0.104 
AUC(0-tau) versus CFB in triglycerides, n=45   0.216 
AUC(0-tau) versus lipase, n=45   -0.066 
AUC(0-tau) versus CFB in lipase, n=45   0.092 
AUC(0-tau) versus total cholesterol, n=45   -0.097 
AUC(0-tau) versus CFB in total cholesterol, n=45   -0.153 
Cmax versus AE occurrence, n=45   0.061 
Cmax versus maximum AE intensity, n=45   0.110 
Cmax versus ALT, n=45   -0.135 
Cmax versus CFB in ALT, n=45   -0.135 
Cmax versus total bilirubin, n=45   0.265 
Cmax versus CFB in total bilirubin, n=45   0.033 
Cmax versus creatine kinase, n=45   -0.188 
Cmax versus CFB in creatine kinase, n=45   -0.161 
Cmax versus triglycerides, n=45   0.134 
Cmax versus CFB in triglycerides, n=45   0.244 
Cmax versus lipase, n=45   -0.034 
Cmax versus CFB in lipase, n=45   0.115 
Cmax versus total cholesterol, n=45   -0.101 
Cmax versus CFB in total cholesterol, n=45   -0.192 
C0 versus AE occurrence, n=133   -0.080 
C0 versus maximum AE intensity, n=133   -0.003 
C0 versus ALT, n=133   -0.196 
C0 versus CFB in ALT, n=133   -0.237 
C0 versus total bilirubin, n=133   0.298 
C0 versus CFB in total bilirubin, n=133   0.120 
C0 versus creatine kinase, n=133   -0.094 
C0 versus CFB in creatine kinase, n=133   -0.093 
C0 versus triglycerides, n=133   -0.058 
C0 versus CFB in triglycerides, n=133   -0.012 
C0 versus lipase, n=133   -0.187 
C0 versus CFB in lipase, n=133   -0.137 
C0 versus total cholesterol, n=133   -0.179 
C0 versus CFB in total cholesterol, n=133   -0.125 
C0avg versus AE occurrence, n=140   -0.028 
C0avg versus maximum AE intensity, n=140   0.036 
C0avg versus ALT, n=140   -0.166 
C0avg versus CFB in ALT, n=140   -0.177 
C0avg versus total bilirubin, n=140   0.319 
C0avg versus CFB in total bilirubin, n=140   0.109 
C0avg versus creatine kinase, n=140   -0.114 
C0avg versus CFB in creatine kinase, n=140   -0.110 
C0avg versus triglycerides, n=140   0.057 
C0avg versus CFB in triglycerides, n=140   0.092 
C0avg versus lipase, n=140   -0.164 
C0avg versus CFB in lipase, n=140   -0.120 
C0avg versus total cholesterol, n=140   -0.170 
C0avg versus CFB in total cholesterol, n=140   -0.083 
Ctau versus AE occurrence, n=45   0.190 
Ctau versus maximum AE intensity, n=45   0.205 
Ctau versus ALT, n=45   -0.281 
Ctau versus CFB in ALT, n=45   -0.285 
Ctau versus total bilirubin, n=45   0.446 
Ctau versus CFB in total bilirubin, n=45   0.237 
Ctau versus creatine kinase, n=45   -0.143 
Ctau versus CFB in creatine kinase, n=45   -0.125 
Ctau versus triglycerides, n=45   0.061 
Ctau versus CFB in triglycerides, n=45   0.172 
Ctau versus lipase, n=45   -0.131 
Ctau versus CFB in lipase, n=45   0.056 
Ctau versus total cholesterol, n=45   -0.039 
Ctau versus CFB in total cholesterol, n=45   -0.108 
Cmin versus AE occurrence, n=45   0.156 
Cmin versus maximum AE intensity, n=45   0.193 
Cmin versus ALT, n=45   -0.236 
Cmin versus CFB in ALT, n=45   -0.253 
Cmin versus total bilirubin, n=45   0.430 
Cmin versus CFB in total bilirubin, n=45   0.171 
Cmin versus creatine kinase, n=45   -0.132 
Cmin versus CFB in creatine kinase, n=45   -0.124 
Cmin versus triglycerides, n=45   -0.042 
Cmin versus CFB in triglycerides, n=45   0.057 
Cmin versus lipase, n=45   -0.135 
Cmin versus CFB in lipase, n=45   0.032 
Cmin versus total cholesterol, n=45   -0.194 
Cmin versus CFB in total cholesterol, n=45   -0.208 

No statistical analysis provided for Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters



22.  Secondary:   Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Measure Description Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).
Time Frame Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.

Reporting Groups
  Description
Overall DTG All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).

Measured Values
   Overall DTG 
Participants Analyzed 
[Units: Participants]
 142 
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters 
[Units: Estimated effect]
 
Abdominal pain versus AUC(0-tau), n=45   -2.49 
Abdominal pain versus Cmax, n=45   -2.98 
Abdominal pain versus Ctau, n=45   -1.72 
Abdominal pain versus C0avg, n=140   -0.41 
Diarrhoea versus AUC(0-tau), n=45   -0.62 
Diarrhoea versus Cmax, n=45   -0.98 
Diarrhoea versus Ctau, n=45   -0.29 
Diarrhoea versus C0avg, n=140   0.13 
Nausea versus AUC(0-tau), n=45   -0.31 
Nausea versus Cmax, n=45   -0.72 
Nausea versus Ctau, n=45   0.03 
Nausea versus C0avg, n=140   -0.32 
Vomiting versus AUC(0-tau), n=45   -1.29 
Vomiting versus Cmax, n=45   -1.61 
Vomiting versus Ctau, n=45   -1.15 
Vomiting versus C0avg, n=140   -0.89 

No statistical analysis provided for Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters



23.  Other Pre-specified:   Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

Measure Type Other Pre-specified
Measure Title Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points
Measure Description Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.
Time Frame Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Measured Values
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD 
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points             

No statistical analysis provided for Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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