Trial Outcomes & Findings for A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults (NCT NCT04493216)
NCT ID: NCT04493216
Last Updated: 2024-06-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
At Week 24
Results posted on
2024-06-26
Participant Flow
This study assessed efficacy, safety and resistance of GSK3640254 in combination with ABC/3TC or FTC/TAF compared to dolutegravir + ABC/3TC or FTC/TAF in HIV-1 infected, treatment-naïve adults. The study was terminated by the sponsor at Week 48 as the sponsor determined further development of GSK3640254-containing daily oral regimen would not be differentiated enough from existing 2-drug daily oral regimens. Thus, secondary analyses at Week 96 and Week 144 were not evaluated.
The changes from the planned subsequent analyses were presented as pre-specified in Statistical Analysis Plan. Safety analysis is presented based on the Entire Duration of Treatment Exposure period, which was defined from Day 1 up to end of continued access to treatment post-study termination (Day 922).
Participant milestones
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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 Study
STARTED
|
40
|
43
|
42
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
43
|
42
|
36
|
Reasons for withdrawal
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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 Study
Study terminated by sponsor
|
30
|
33
|
28
|
27
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
4
|
5
|
2
|
|
Overall Study
Subject reached protocol-defined stopping criteria
|
4
|
2
|
7
|
2
|
Baseline Characteristics
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.8 YEARS
STANDARD_DEVIATION 6.20 • n=99 Participants
|
38.1 YEARS
STANDARD_DEVIATION 12.54 • n=107 Participants
|
33.7 YEARS
STANDARD_DEVIATION 10.59 • n=206 Participants
|
35.3 YEARS
STANDARD_DEVIATION 9.85 • n=7 Participants
|
35.0 YEARS
STANDARD_DEVIATION 10.25 • n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
123 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
124 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
MIXED RACE
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
MISSING
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which included all randomized participants who received at least one dose of study intervention.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24
|
82.5 Percentage of participants
Interval 68.1 to 91.3
|
90.7 Percentage of participants
Interval 78.4 to 96.3
|
76.2 Percentage of participants
Interval 61.5 to 86.5
|
91.7 Percentage of participants
Interval 78.2 to 97.1
|
SECONDARY outcome
Timeframe: At Week 48Population: The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48
|
85.0 Percentage of participants
Interval 70.9 to 92.9
|
83.7 Percentage of participants
Interval 70.0 to 91.9
|
76.2 Percentage of participants
Interval 61.5 to 86.5
|
77.8 Percentage of participants
Interval 61.9 to 88.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Absolute Values of HIV-1 RNA at Weeks 24 and 48
Baseline (Day 1)
|
4.351 Log 10 copies per milliliter
Standard Deviation 0.5712
|
4.353 Log 10 copies per milliliter
Standard Deviation 0.6705
|
4.165 Log 10 copies per milliliter
Standard Deviation 0.6505
|
4.247 Log 10 copies per milliliter
Standard Deviation 0.6765
|
|
Absolute Values of HIV-1 RNA at Weeks 24 and 48
Week 24
|
1.619 Log 10 copies per milliliter
Standard Deviation 0.1260
|
1.607 Log 10 copies per milliliter
Standard Deviation 0.0663
|
1.610 Log 10 copies per milliliter
Standard Deviation 0.0679
|
1.592 Log 10 copies per milliliter
Standard Deviation 0.0126
|
|
Absolute Values of HIV-1 RNA at Weeks 24 and 48
Week 48
|
1.602 Log 10 copies per milliliter
Standard Deviation 0.0536
|
1.605 Log 10 copies per milliliter
Standard Deviation 0.0647
|
1.594 Log 10 copies per milliliter
Standard Deviation 0.0233
|
1.590 Log 10 copies per milliliter
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma HIV-1 RNA at Weeks 24 and 48
Baseline (Day 1)
|
4.351 Log 10 copies per milliliter
Standard Deviation 0.5712
|
4.353 Log 10 copies per milliliter
Standard Deviation 0.6705
|
4.165 Log 10 copies per milliliter
Standard Deviation 0.6505
|
4.247 Log 10 copies per milliliter
Standard Deviation 0.6765
|
|
Change From Baseline in Plasma HIV-1 RNA at Weeks 24 and 48
Change from Baseline to Week 24
|
-2.718 Log 10 copies per milliliter
Standard Deviation 0.5501
|
-2.784 Log 10 copies per milliliter
Standard Deviation 0.6615
|
-2.565 Log 10 copies per milliliter
Standard Deviation 0.6513
|
-2.629 Log 10 copies per milliliter
Standard Deviation 0.6835
|
|
Change From Baseline in Plasma HIV-1 RNA at Weeks 24 and 48
Change from Baseline to Week 48
|
-2.675 Log 10 copies per milliliter
Standard Deviation 0.5640
|
-2.762 Log 10 copies per milliliter
Standard Deviation 0.6784
|
-2.580 Log 10 copies per milliliter
Standard Deviation 0.6941
|
-2.717 Log 10 copies per milliliter
Standard Deviation 0.6672
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48
Baseline (Day 1)
|
480.3 Cells per cubic millimeter
Standard Deviation 171.72
|
509.7 Cells per cubic millimeter
Standard Deviation 207.13
|
478.7 Cells per cubic millimeter
Standard Deviation 204.04
|
514.1 Cells per cubic millimeter
Standard Deviation 240.88
|
|
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48
Week 24
|
717.5 Cells per cubic millimeter
Standard Deviation 222.91
|
643.5 Cells per cubic millimeter
Standard Deviation 202.27
|
689.8 Cells per cubic millimeter
Standard Deviation 316.64
|
724.8 Cells per cubic millimeter
Standard Deviation 403.99
|
|
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Counts at Weeks 24 and 48
Week 48
|
749.9 Cells per cubic millimeter
Standard Deviation 328.28
|
702.6 Cells per cubic millimeter
Standard Deviation 258.65
|
747.3 Cells per cubic millimeter
Standard Deviation 313.15
|
705.2 Cells per cubic millimeter
Standard Deviation 221.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in CD4+ Cell Counts at Weeks 24 and 48
Baseline (Day 1)
|
480.3 Cells per cubic millimeter
Standard Deviation 171.72
|
509.7 Cells per cubic millimeter
Standard Deviation 207.13
|
478.7 Cells per cubic millimeter
Standard Deviation 204.04
|
514.1 Cells per cubic millimeter
Standard Deviation 240.88
|
|
Change From Baseline in CD4+ Cell Counts at Weeks 24 and 48
Change from Baseline to Week 24
|
241.3 Cells per cubic millimeter
Standard Deviation 191.26
|
129.3 Cells per cubic millimeter
Standard Deviation 233.07
|
202.3 Cells per cubic millimeter
Standard Deviation 271.98
|
198.5 Cells per cubic millimeter
Standard Deviation 285.00
|
|
Change From Baseline in CD4+ Cell Counts at Weeks 24 and 48
Change from Baseline to Week 48
|
292.4 Cells per cubic millimeter
Standard Deviation 264.16
|
189.2 Cells per cubic millimeter
Standard Deviation 216.10
|
243.0 Cells per cubic millimeter
Standard Deviation 233.24
|
190.6 Cells per cubic millimeter
Standard Deviation 180.19
|
SECONDARY outcome
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 922)Population: The analysis was performed on the Safety Population, which 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.
An SAE was defined as any serious adverse event that, at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Deaths
Serious Adverse Events
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 922)Population: The analysis was performed on the Safety Population, which 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.
An AE was 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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Treatment Discontinuation
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 922)Population: The analysis was performed on the Safety Population, which 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. The data presented here is not cumulative data but the number of participants experiencing the adverse event based on maximum grade at the indicated timepoints.
An AE was 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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With AEs Based on Maximum Severity Grades
Grade 1
|
12 Participants
|
14 Participants
|
17 Participants
|
15 Participants
|
|
Number of Participants With AEs Based on Maximum Severity Grades
Grade 2
|
19 Participants
|
17 Participants
|
17 Participants
|
10 Participants
|
|
Number of Participants With AEs Based on Maximum Severity Grades
Grade 3
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With AEs Based on Maximum Severity Grades
Grade 4
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With AEs Based on Maximum Severity Grades
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 922)Population: The analysis was performed on the Safety Population, which 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.
An AE was 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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Gastrointestinal)
|
15 Participants
|
18 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Nervous system)
|
7 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Psychiatric)
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the PDVF Population, which included participants 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).
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=3 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=2 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=5 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=1 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Genotypic Resistance
Baseline (Day 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance
Weeks 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Genotypic Resistance
Weeks 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 24 and 48Population: The analysis was performed on the PDVF Population. Only those participants with data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=3 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=2 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=5 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=1 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Phenotypic Resistance
Weeks 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance
Weeks 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Phenotypic Resistance
Baseline (Day 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and where samples were collected according to the intensive PK sampling scheme. Only those participants who received GSK3640254 have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=14 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Week 2
|
430.5361 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 56.5
|
604.8387 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 44.2
|
805.2209 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 43.7
|
—
|
SECONDARY outcome
Timeframe: At Weeks 24 and 48Population: The analysis was performed on the Sparse PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and had samples collected according to the sparse PK sampling scheme. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=12 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=10 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=13 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Weeks 24 and 48
Week 24
|
396.5117 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 62.5
|
519.6041 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 84.9
|
922.9638 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 51.6
|
—
|
|
Observed Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 at Steady State - Weeks 24 and 48
Week 48
|
310.9877 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 135.4
|
568.0656 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 13.4
|
812.4745 Nanogram/ milliliter (ng/mL)
Geometric Coefficient of Variation 49.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=14 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
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
|
14995.7576 Hour*nanogram/ milliliter (h*ng/mL)
Geometric Coefficient of Variation 49.8
|
21212.2480 Hour*nanogram/ milliliter (h*ng/mL)
Geometric Coefficient of Variation 44.5
|
30708.2546 Hour*nanogram/ milliliter (h*ng/mL)
Geometric Coefficient of Variation 40.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=15 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GSK3640254 at Steady State
|
929.8 ng/mL
Geometric Coefficient of Variation 45.9
|
1337.3 ng/mL
Geometric Coefficient of Variation 47.7
|
2094.5 ng/mL
Geometric Coefficient of Variation 39.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
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.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=15 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Observed Pre-dose Plasma Concentration (C0) of GSK3640254 at Steady State
|
435.9 ng/mL
Geometric Coefficient of Variation 54.6
|
603.2 ng/mL
Geometric Coefficient of Variation 59.5
|
865.2 ng/mL
Geometric Coefficient of Variation 43.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254. Tmax was determined directly from the concentration-time data.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=15 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Time to Cmax (Tmax) of GSK3640254 at Steady State
|
3.0000 Hour
Interval 1.9 to 9.017
|
3.4167 Hour
Interval 1.0 to 9.0
|
3.4583 Hour
Interval 1.917 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2Population: The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Outcome measures
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=14 Participants
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=13 Participants
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=18 Participants
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
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.
|
|---|---|---|---|---|
|
Steady State Oral Clearance (CLt/F) of GSK3640254
|
6.6686 Liter/ hour
Geometric Coefficient of Variation 49.8
|
7.0714 Liter/ hour
Geometric Coefficient of Variation 44.5
|
6.5129 Liter/ hour
Geometric Coefficient of Variation 40.1
|
—
|
Adverse Events
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
GSK3640254 150 mg + ABC/3TC or FTC/TAF
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 participants at risk
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 participants at risk
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 participants at risk
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Psychiatric disorders
Substance dependence
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Psychiatric disorders
Suicidal ideation
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
Other adverse events
| Measure |
GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
n=40 participants at risk
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.
|
GSK3640254 150 mg + ABC/3TC or FTC/TAF
n=43 participants at risk
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.
|
GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
n=42 participants at risk
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.
|
Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
n=36 participants at risk
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.
|
|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
7.5%
3/40 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
5.6%
2/36 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
16.3%
7/43 • Number of events 8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
14.3%
6/42 • Number of events 7 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
25.0%
9/36 • Number of events 10 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Food poisoning
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.7%
2/43 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
5.6%
2/36 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
14.0%
6/43 • Number of events 8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
5.6%
2/36 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
General disorders
Asthenia
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
General disorders
Pyrexia
|
10.0%
4/40 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
9.3%
4/43 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
COVID-19
|
25.0%
10/40 • Number of events 12 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
27.9%
12/43 • Number of events 12 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
14.3%
6/42 • Number of events 7 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
27.8%
10/36 • Number of events 13 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Chlamydial infection
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.7%
2/43 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Gonorrhoea
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Influenza
|
7.5%
3/40 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
9.3%
4/43 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
11.1%
4/36 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Monkeypox
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Pharyngitis
|
10.0%
4/40 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
9.3%
4/43 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Respiratory tract infection
|
7.5%
3/40 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/43 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Syphilis
|
7.5%
3/40 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
13.9%
5/36 • Number of events 6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
4/40 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.1%
3/42 • Number of events 5 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Infections and infestations
Urethritis
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/42 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
5.6%
2/36 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.7%
2/43 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
7.0%
3/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Number of events 6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
9.3%
4/43 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
16.7%
7/42 • Number of events 10 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.5%
3/40 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.3%
1/43 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.8%
1/36 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.7%
2/43 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.8%
2/42 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
8.3%
3/36 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
4.7%
2/43 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
0.00%
0/36 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER