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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00951015
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : November 11, 2013
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: efavirenz

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Randomization Phase participants received Dolutegravir (DTG 10, 25 or 50 milligrams[mg]) with Placebo/Efavirenz (EFV) for 96 Weeks . DTG participants who completed 96 Weeks continued or were switched to receive DTG 50 mg in Open label phase until DTG was locally available.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 278 par were screened of which 70 were screen failures and 208 were randomized; 205 received at least one dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. 17 participants out of 155 from DTG arm withdrew during Randomization phase and total 138 participants were enrolled in an Open-label phase.

Reporting Groups
  Description
DTG 10 mg QD Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
DTG 25 mg QD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
DTG 50 mg QD Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
EFV 600 mg QD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Open-label DTG 50 mg QD All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase

Participant Flow for 2 periods

Period 1:   Randomization Phase 96 Week
    DTG 10 mg QD   DTG 25 mg QD   DTG 50 mg QD   EFV 600 mg QD   Open-label DTG 50 mg QD
STARTED   53   51   51   50   0 
COMPLETED   48   44   46   40   0 
NOT COMPLETED   5   7   5   10   0 
Adverse Event                1                1                2                5                0 
Lack of Efficacy                1                1                0                0                0 
Protocol Violation                1                1                1                0                0 
Protocol-Defined Stopping Criteria                0                0                0                1                0 
Lost to Follow-up                0                3                1                2                0 
Withdrawal by Subject                2                1                1                2                0 

Period 2:   Open-label Phase
    DTG 10 mg QD   DTG 25 mg QD   DTG 50 mg QD   EFV 600 mg QD   Open-label DTG 50 mg QD
STARTED   0   0   0   0   138 
COMPLETED   0   0   0   0   88 
NOT COMPLETED   0   0   0   0   50 
Adverse Event                0                0                0                0                3 
Lack of Efficacy                0                0                0                0                1 
Protocol Violation                0                0                0                0                12 
Lost to Follow-up                0                0                0                0                12 
Withdrawal by Subject                0                0                0                0                14 
Physician Decision                0                0                0                0                8 



  Baseline Characteristics

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 QD 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 (QD) for 96 weeks.
DTG 25 mg QD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
DTG 50 mg QD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
EFV 600 mg QD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Total Total of all reporting groups

Baseline Measures
   DTG 10 mg QD   DTG 25 mg QD   DTG 50 mg QD   EFV 600 mg QD   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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      11  20.8%      5   9.8%      6  11.8%      6  12.0%      28  13.7% 
Male      42  79.2%      46  90.2%      45  88.2%      44  88.0%      177  86.3% 
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

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 ]

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

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 ]

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 ]

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

16.  Secondary:   Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG   [ Time Frame: Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

17.  Secondary:   Pre-dose Concentration (C0) and C0 Avg of DTG   [ Time Frame: Week 2, Week 12, and Week 24 ]

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 ]

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 ]

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 ]

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

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

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

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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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