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A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults (DOMINO)

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: NCT04493216
Recruitment Status : Terminated (Company decision to stop compound development. The decision is not based on any safety or efficacy concerns. It reflects the company strategy for portfolio progression.)
First Posted : July 30, 2020
Results First Posted : November 18, 2023
Last Update Posted : November 18, 2023
Sponsor:
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 HIV Infections
Interventions Drug: GSK3640254
Drug: ABC/3TC
Drug: FTC/TAF
Drug: Dolutegravir
Drug: Placebo
Enrollment 169
Recruitment Details The results presented are based on the data up to a maximum of Week 48 (Partially Blind Randomised Phase). Data analysis is still ongoing and additional results will be provided. The study is terminated based on company decision to stop compound development. The decision is not based on any safety or efficacy concerns. It reflects the company strategy for portfolio progression.
Pre-assignment Details  
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally. Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Period Title: Overall Study
Started 40 43 42 36
Completed 0 0 0 0
Not Completed 40 43 42 36
Reason Not Completed
Adverse Event             1             4             5             2
Lost to Follow-up             1             1             0             1
Physician Decision             0             0             1             0
Withdrawal by Subject             1             1             1             2
Ongoing             18             18             16             16
Site closed             14             15             11             11
Subject Reached Protocol-Defined Stopping Criteria             4             2             8             2
Protocol Deviation             1             2             0             2
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF Total
Hide Arm/Group Description Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally. Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Total of all reporting groups
Overall Number of Baseline Participants 40 43 42 36 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  YEARS
Number Analyzed 40 participants 43 participants 42 participants 36 participants 161 participants
32.8  (6.20) 38.1  (12.54) 33.7  (10.59) 35.3  (9.85) 35.0  (10.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 42 participants 36 participants 161 participants
Female
7
  17.5%
9
  20.9%
12
  28.6%
10
  27.8%
38
  23.6%
Male
33
  82.5%
34
  79.1%
30
  71.4%
26
  72.2%
123
  76.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 40 participants 43 participants 42 participants 36 participants 161 participants
AMERICAN INDIAN OR ALASKA NATIVE
1
   2.5%
2
   4.7%
1
   2.4%
0
   0.0%
4
   2.5%
ASIAN
0
   0.0%
2
   4.7%
2
   4.8%
1
   2.8%
5
   3.1%
BLACK OR AFRICAN AMERICAN
6
  15.0%
8
  18.6%
6
  14.3%
6
  16.7%
26
  16.1%
WHITE
32
  80.0%
31
  72.1%
32
  76.2%
29
  80.6%
124
  77.0%
MIXED RACE
1
   2.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
MISSING
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
   0.6%
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL at week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population included all randomized participants who received at least one dose of study intervention.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
82.5
(68.1 to 91.3)
90.7
(78.4 to 96.3)
76.2
(61.5 to 86.5)
91.7
(78.2 to 97.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF, Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in percentage of participant
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-24.0 to 5.7
Estimation Comments Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK3640254 150 mg + ABC/3TC or FTC/TAF, Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in percentage of participant
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-13.5 to 11.6
Estimation Comments Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF, Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in percentage of participant
Estimated Value -15.5
Confidence Interval (2-Sided) 95%
-31.2 to 0.3
Estimation Comments Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL at week 48 was assessed using the FDA snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.0
(70.9 to 92.9)
83.7
(70.0 to 91.9)
76.2
(61.5 to 86.5)
77.8
(61.9 to 88.3)
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Hide Description Percentage of participants with plasma HIV-1 RNA <50 c/mL at week 96 will be assessed using the FDA snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF.
Time Frame At Week 96
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Absolute Values of HIV-1 RNA at Weeks 24 and 48
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population. Only those participants with data available at specified time points have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1) Number Analyzed 40 participants 43 participants 42 participants 36 participants
4.351  (0.5712) 4.353  (0.6705) 4.165  (0.6505) 4.247  (0.6765)
Week 24 Number Analyzed 38 participants 39 participants 33 participants 31 participants
1.619  (0.1260) 1.607  (0.0663) 1.610  (0.0679) 1.592  (0.0126)
Week 48 Number Analyzed 33 participants 37 participants 31 participants 28 participants
1.602  (0.0536) 1.605  (0.0647) 1.594  (0.0233) 1.590  (0.0000)
5.Secondary Outcome
Title Absolute Values of HIV-1 RNA at Week 96
Hide Description Plasma samples will be collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA will be presented. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA at Weeks 24 and 48
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. log10 values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population. Only those participants with data available at specified time points have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Mean (Standard Deviation)
Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1) Number Analyzed 40 participants 43 participants 42 participants 36 participants
4.351  (0.5712) 4.353  (0.6705) 4.165  (0.6505) 4.247  (0.6765)
Change from Baseline to Week 24 Number Analyzed 38 participants 39 participants 33 participants 31 participants
-2.718  (0.5501) -2.784  (0.6615) -2.565  (0.6513) -2.629  (0.6835)
Change from Baseline to Week 48 Number Analyzed 33 participants 37 participants 31 participants 28 participants
-2.675  (0.5640) -2.762  (0.6784) -2.580  (0.6941) -2.717  (0.6672)
7.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA at Week 96
Hide Description Plasma samples will be collected for quantitative analysis of HIV-1 RNA. log10 values for plasma HIV-1 RNA will be presented. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline will be defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48
Hide Description Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population. Only those participants with data available at specified time points have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Baseline (Day 1) Number Analyzed 40 participants 43 participants 42 participants 36 participants
480.3  (171.72) 509.7  (207.13) 478.7  (204.04) 514.1  (240.88)
Week 24 Number Analyzed 36 participants 37 participants 34 participants 31 participants
717.5  (222.91) 643.5  (202.27) 689.8  (316.64) 724.8  (403.99)
Week 48 Number Analyzed 32 participants 36 participants 30 participants 28 participants
749.9  (328.28) 702.6  (258.65) 747.3  (313.15) 705.2  (221.18)
9.Secondary Outcome
Title Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Week 96
Hide Description Blood samples will be collected and CD4+ cell count will be assessed using flow cytometry. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in CD4+ Cell Counts at Weeks 24 and 48
Hide Description Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) population. Only those participants with data available at specified time points have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Baseline (Day 1) Number Analyzed 40 participants 43 participants 42 participants 36 participants
480.3  (171.72) 509.7  (207.13) 478.7  (204.04) 514.1  (240.88)
Change from Baseline to Week 24 Number Analyzed 36 participants 37 participants 34 participants 31 participants
241.3  (191.26) 129.3  (233.07) 202.3  (271.98) 198.5  (285.00)
Change from Baseline to Week 48 Number Analyzed 32 participants 36 participants 30 participants 28 participants
292.4  (264.16) 189.2  (216.10) 243.0  (233.24) 190.6  (180.19)
11.Secondary Outcome
Title Change From Baseline in CD4+ Cell Counts at Week 96
Hide Description Blood samples will be collected and CD4+ cell count will be assessed using flow cytometry. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline will be defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Deaths Through Weeks 24 and 48
Hide Description An SAE is defined as any serious adverse event that, at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other situation according to medical or scientific judgment.
Time Frame Up to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24, SAEs
2
   5.0%
4
   9.3%
2
   4.8%
2
   5.6%
Week 48, SAEs
2
   5.0%
7
  16.3%
2
   4.8%
2
   5.6%
Week 24, Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 48, Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Deaths Through Week 96
Hide Description An SAE will be defined as any serious adverse event that, at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other situation according to medical or scientific judgment.
Time Frame Up to Week 96
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) Leading to Treatment Discontinuation Through Weeks 24 and 48
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants who discontinued study treatment due to AEs are presented.
Time Frame Up to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24
2
   5.0%
3
   7.0%
4
   9.5%
2
   5.6%
Week 48
2
   5.0%
4
   9.3%
5
  11.9%
2
   5.6%
15.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) Leading to Treatment Discontinuation Through Week 96
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants who discontinue study treatment due to AEs will be presented.
Time Frame Up to Week 96
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Number of Participants With AEs Based on Maximum Severity Grades at Weeks 24 and 48
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The severity of AEs was defined as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 and was categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening and Grade 5 - Fatal. Higher grade indicates more severe condition. Number of participants with adverse events by maximum grade have been presented.
Time Frame At Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. The data presented here is not a cumulative data but number of participants experiencing the adverse event based on maximum grade at the indicated timepoints.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
Weeks 24, Grade 1
14
  35.0%
18
  41.9%
16
  38.1%
15
  41.7%
Weeks 48, Grade 1
12
  30.0%
14
  32.6%
17
  40.5%
15
  41.7%
Weeks 24, Grade 2
16
  40.0%
16
  37.2%
18
  42.9%
10
  27.8%
Weeks 48, Grade 2
20
  50.0%
17
  39.5%
17
  40.5%
10
  27.8%
Weeks 24, Grade 3
4
  10.0%
3
   7.0%
2
   4.8%
3
   8.3%
Weeks 48, Grade 3
4
  10.0%
5
  11.6%
3
   7.1%
3
   8.3%
Weeks 24, Grade 4
1
   2.5%
1
   2.3%
1
   2.4%
0
   0.0%
Weeks 48, Grade 4
1
   2.5%
2
   4.7%
1
   2.4%
0
   0.0%
Weeks 24, Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weeks 48, Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With AEs Based on Maximum Severity Grades at Week 96
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The severity of AEs will be defined as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 and will be categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening and Grade 5 - Fatal. Higher grade will indicate more severe condition. Number of participants with adverse events by maximum grade will be presented.
Time Frame At Week 96
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Number of Participants With AEs of Special Interest (AESI) (Gastrointestinal (GI), Nervous System, and Psychiatric AEs) Through Weeks 24 and 48
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI (gastrointestinal (GI), nervous system, and psychiatric AEs) are presented.
Time Frame At Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 40 43 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24, AESI (Gastrointestinal)
13
  32.5%
18
  41.9%
12
  28.6%
11
  30.6%
Week 48, AESI (Gastrointestinal)
14
  35.0%
18
  41.9%
14
  33.3%
14
  38.9%
Week 24, AESI (Nervous system)
5
  12.5%
4
   9.3%
7
  16.7%
3
   8.3%
Week 48, AESI (Nervous system)
7
  17.5%
5
  11.6%
8
  19.0%
3
   8.3%
Week 24, AESI (Psychiatric)
1
   2.5%
3
   7.0%
2
   4.8%
2
   5.6%
Week 48, AESI (Psychiatric)
4
  10.0%
3
   7.0%
4
   9.5%
4
  11.1%
19.Secondary Outcome
Title Number of Participants With AEs of Special Interest (AESI) (Gastrointestinal (GI), Nervous System, and Psychiatric AEs) Through Week 96
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI (gastrointestinal (GI), nervous system, and psychiatric AEs) will be presented.
Time Frame At Week 96
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Number of Participants With Genotypic Resistance
Hide Description Plasma samples were collected for resistance testing. Genotypic testing was conducted in participants meeting protocol-defined virologic failure (PDVF) criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only those participants with data available at specified time points have been analyzed.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol-defined virologic failure (PDVF) population included participant with A. virologic non-response (Decrease from Baseline (Day 1) in plasma HIV-1 RNA of ˂1.0 log10 c/mL unless plasma HIV-1 RNA is <200 c/mL by Week 12; confirmed plasma HIV-1 RNA levels ≥200 c/mL at or after Week 24; plasma HIV-1 RNA ≥50 c/mL on repeat testing of Week 24 results and prior to Week 28) and B. virologic rebound (confirmed plasma HIV-1 RNA ≥200 c/mL after confirmed consecutive plasma HIV-1 RNA <50 c/mL).
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 3 2 5 1
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (Day 1) Number Analyzed 3 participants 1 participants 4 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weeks 24 Number Analyzed 3 participants 1 participants 4 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weeks 48 Number Analyzed 3 participants 2 participants 5 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Genotypic Resistance - Week 96
Hide Description Plasma samples will be collected for resistance testing. Genotypic testing will be conducted in participants meeting protocol-defined virologic failure (PDVF) criteria. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Number of Participants With Phenotypic Resistance
Hide Description Plasma samples were collected for resistance testing. Phenotypic testing was conducted in participants meeting PDVF criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol-defined virologic failure (PDVF) population. Only those participants with data available at specified time points have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 3 2 5 1
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (Day 1) Number Analyzed 3 participants 1 participants 4 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weeks 24 Number Analyzed 3 participants 1 participants 4 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weeks 48 Number Analyzed 3 participants 2 participants 5 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Phenotypic Resistance - Week 96
Hide Description Plasma samples will be collected for resistance testing. Phenotypic testing will be conducted in participants meeting PDVF criteria. Baseline will be defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame Baseline (Day 1) and at Week 96
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Week 2
Hide Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population included all participants who received at least one dose of GSK3640254 and have evaluable drug concentrations reported, where samples are collected according to the intensive PK sampling scheme. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 14 13 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/ milliliter (ng/mL)
430.5361
(56.5%)
604.8387
(44.2%)
805.2209
(43.7%)
25.Secondary Outcome
Title Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Weeks 24 and 48
Hide Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data.
Time Frame At Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Sparse PK population included all participants who received at least one dose of GSK3640254 and have evaluable drug concentrations reported, where samples are collected according to the sparse PK sampling scheme. Only those participants with data available at specified time points have been analyzed. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 12 10 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/ milliliter (ng/mL)
Week 24 Number Analyzed 12 participants 10 participants 13 participants
396.5117
(62.5%)
519.6041
(84.9%)
922.9638
(51.6%)
Week 48 Number Analyzed 9 participants 6 participants 6 participants
310.9877
(135.4%)
568.0656
(13.4%)
812.4745
(49.1%)
26.Secondary Outcome
Title Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval (AUC [0-tau]) of GSK3640254 at Steady State
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 14 13 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram/ milliliter (h*ng/mL)
14995.7576
(49.8%)
21212.2480
(44.5%)
30708.2546
(40.1%)
27.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of GSK3640254 at Steady State
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 15 13 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
929.8
(45.9%)
1337.3
(47.7%)
2094.5
(39.2%)
28.Secondary Outcome
Title Observed Pre-dose Plasma Concentration (C0) of GSK3640254 at Steady State
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK3640254. Observed pre-dose plasma concentration was determined directly from the concentration-time data.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 15 13 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
435.9
(54.6%)
603.2
(59.5%)
865.2
(43.4%)
29.Secondary Outcome
Title Time to Cmax (Tmax) of GSK3640254 at Steady State
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK3640254. Tmax was determined directly from the concentration-time data.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 15 13 18
Median (Full Range)
Unit of Measure: Hour
3.0000
(1.900 to 9.017)
3.4167
(1.000 to 9.000)
3.4583
(1.917 to 5.000)
30.Secondary Outcome
Title Steady State Oral Clearance (CLt/F) of GSK3640254
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Time Frame Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive pharmacokinetic (PK) population. Only those participants who received GSK3640254 have been analyzed.
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Hide Arm/Group Description:
Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
Overall Number of Participants Analyzed 14 13 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter/ hour
6.6686
(49.8%)
7.0714
(44.5%)
6.5129
(40.1%)
Time Frame All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 48 weeks
Adverse Event Reporting Description Safety population included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention. Data analysis is still ongoing and additional results will be provided.
 
Arm/Group Title GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Hide Arm/Group Description Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally. Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally. Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
All-Cause Mortality
GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/43 (0.00%)      0/42 (0.00%)      0/36 (0.00%)    
Hide Serious Adverse Events
GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/40 (5.00%)      7/43 (16.28%)      2/42 (4.76%)      2/36 (5.56%)    
Gastrointestinal disorders         
Colitis † 1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/42 (0.00%)  0 1/36 (2.78%)  1
Pancreatitis † 1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/42 (2.38%)  1 0/36 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute † 1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/42 (0.00%)  0 0/36 (0.00%)  0
Infections and infestations         
Appendicitis † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Cellulitis † 1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/42 (0.00%)  0 1/36 (2.78%)  1
Necrotising fasciitis † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Injury, poisoning and procedural complications         
Ankle fracture † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Limb fracture † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/42 (2.38%)  1 0/36 (0.00%)  0
Psychiatric disorders         
Substance dependence † 1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/42 (0.00%)  0 1/36 (2.78%)  1
Suicidal ideation † 1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/42 (0.00%)  0 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Pulmonary hypertension † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis allergic † 1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/42 (0.00%)  0 0/36 (0.00%)  0
1
Term from vocabulary, V25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
GSK3640254 100 Milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/40 (92.50%)      37/43 (86.05%)      38/42 (90.48%)      27/36 (75.00%)    
Gastrointestinal disorders         
Abdominal pain † 1  2/40 (5.00%)  2 1/43 (2.33%)  1 3/42 (7.14%)  3 2/36 (5.56%)  2
Abdominal pain upper † 1  1/40 (2.50%)  1 3/43 (6.98%)  3 3/42 (7.14%)  3 3/36 (8.33%)  3
Diarrhoea † 1  5/40 (12.50%)  5 7/43 (16.28%)  8 6/42 (14.29%)  7 9/36 (25.00%)  10
Dyspepsia † 1  1/40 (2.50%)  1 1/43 (2.33%)  1 2/42 (4.76%)  3 1/36 (2.78%)  1
Food poisoning † 1  2/40 (5.00%)  2 0/43 (0.00%)  0 1/42 (2.38%)  1 1/36 (2.78%)  1
Haemorrhoids † 1  0/40 (0.00%)  0 2/43 (4.65%)  2 0/42 (0.00%)  0 2/36 (5.56%)  2
Nausea † 1  2/40 (5.00%)  2 6/43 (13.95%)  8 3/42 (7.14%)  3 1/36 (2.78%)  1
Toothache † 1  0/40 (0.00%)  0 2/43 (4.65%)  3 2/42 (4.76%)  2 1/36 (2.78%)  1
Vomiting † 1  2/40 (5.00%)  2 3/43 (6.98%)  3 0/42 (0.00%)  0 0/36 (0.00%)  0
General disorders         
Asthenia † 1  2/40 (5.00%)  2 0/43 (0.00%)  0 3/42 (7.14%)  3 1/36 (2.78%)  2
Pyrexia † 1  4/40 (10.00%)  5 4/43 (9.30%)  4 1/42 (2.38%)  1 1/36 (2.78%)  1
Infections and infestations         
COVID-19 † 1  10/40 (25.00%)  12 12/43 (27.91%)  12 6/42 (14.29%)  7 10/36 (27.78%)  13
Chlamydial infection † 1  2/40 (5.00%)  2 0/43 (0.00%)  0 1/42 (2.38%)  2 1/36 (2.78%)  1
Gastroenteritis † 1  1/40 (2.50%)  1 2/43 (4.65%)  2 2/42 (4.76%)  2 0/36 (0.00%)  0
Gonorrhoea † 1  2/40 (5.00%)  2 0/43 (0.00%)  0 2/42 (4.76%)  2 0/36 (0.00%)  0
Influenza † 1  3/40 (7.50%)  3 4/43 (9.30%)  4 3/42 (7.14%)  3 4/36 (11.11%)  5
Monkeypox † 1  1/40 (2.50%)  1 1/43 (2.33%)  1 2/42 (4.76%)  2 1/36 (2.78%)  1
Nasopharyngitis † 1  4/40 (10.00%)  5 3/43 (6.98%)  4 3/42 (7.14%)  5 3/36 (8.33%)  6
Pharyngitis † 1  4/40 (10.00%)  4 4/43 (9.30%)  5 1/42 (2.38%)  1 3/36 (8.33%)  3
Respiratory tract infection † 1  3/40 (7.50%)  3 0/43 (0.00%)  0 1/42 (2.38%)  1 0/36 (0.00%)  0
Syphilis † 1  3/40 (7.50%)  3 1/43 (2.33%)  1 3/42 (7.14%)  3 5/36 (13.89%)  6
Upper respiratory tract infection † 1  4/40 (10.00%)  5 3/43 (6.98%)  3 3/42 (7.14%)  5 1/36 (2.78%)  1
Urethritis † 1  1/40 (2.50%)  1 1/43 (2.33%)  1 0/42 (0.00%)  0 2/36 (5.56%)  2
Injury, poisoning and procedural complications         
Limb injury † 1  1/40 (2.50%)  1 1/43 (2.33%)  1 2/42 (4.76%)  2 1/36 (2.78%)  1
Investigations         
Blood creatine phosphokinase increased † 1  3/40 (7.50%)  3 0/43 (0.00%)  0 1/42 (2.38%)  1 1/36 (2.78%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts † 1  1/40 (2.50%)  1 2/43 (4.65%)  2 1/42 (2.38%)  1 0/36 (0.00%)  0
Nervous system disorders         
Dizziness † 1  2/40 (5.00%)  2 3/43 (6.98%)  3 2/42 (4.76%)  3 1/36 (2.78%)  1
Headache † 1  6/40 (15.00%)  6 4/43 (9.30%)  4 7/42 (16.67%)  10 3/36 (8.33%)  4
Psychiatric disorders         
Anxiety † 1  1/40 (2.50%)  1 1/43 (2.33%)  1 1/42 (2.38%)  1 3/36 (8.33%)  3
Respiratory, thoracic and mediastinal disorders         
Rhinitis allergic † 1  3/40 (7.50%)  3 1/43 (2.33%)  1 1/42 (2.38%)  1 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders         
Rash † 1  2/40 (5.00%)  2 2/43 (4.65%)  3 2/42 (4.76%)  2 3/36 (8.33%)  4
Vascular disorders         
Hypertension † 1  2/40 (5.00%)  2 2/43 (4.65%)  2 1/42 (2.38%)  1 0/36 (0.00%)  0
1
Term from vocabulary, V25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT04493216    
Other Study ID Numbers: 208379
First Submitted: July 10, 2020
First Posted: July 30, 2020
Results First Submitted: September 5, 2023
Results First Posted: November 18, 2023
Last Update Posted: November 18, 2023