Trial Outcomes & Findings for A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects (NCT NCT01499199)
NCT ID: NCT01499199
Last Updated: 2015-02-25
Results Overview
Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF\_plasma) was calculated at the Week 2 and Week 16 visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Week 2 and Week 16
Results posted on
2015-02-25
Participant Flow
Eligible participants received dolutegravir (DTG ) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) for 96 weeks.
Participant milestones
| Measure |
Dolutegravir 50 mg OD
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
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11
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Dolutegravir 50 mg OD
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Overall Study
Adverse Event
|
1
|
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Overall Study
Lack of Efficacy
|
1
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Baseline Characteristics
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
Baseline characteristics by cohort
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 6.90 • n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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13 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
White
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13 participants
n=5 Participants
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Baseline plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA)
|
4.73 log10 copies/mL
n=5 Participants
|
|
Number of participants with Baseline plasma HIV-1 RNA <=100000 copies/mL and >100000 copies/mL
<=100000 copies/mL
|
8 Participants
n=5 Participants
|
|
Number of participants with Baseline plasma HIV-1 RNA <=100000 copies/mL and >100000 copies/mL
>100000 copies/mL
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 and Week 16Population: Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.
Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF\_plasma) was calculated at the Week 2 and Week 16 visits.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=12 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16
Week 2, n=11
|
0.516 percentage
Interval 0.115 to 0.658
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The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16
Week 16, n=12
|
0.412 percentage
Interval 0.299 to 2.04
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PRIMARY outcome
Timeframe: Week 2 and Week 16Population: Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data
Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=12 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Total DTG Plasma Concentrations at Week 2 and Week 16
Week 2
|
3.36 Micrograms per milliliter (µg/mL)
Interval 2.09 to 5.28
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Total DTG Plasma Concentrations at Week 2 and Week 16
Week 16
|
3.21 Micrograms per milliliter (µg/mL)
Interval 0.64 to 4.92
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PRIMARY outcome
Timeframe: Week 2 and Week 16Population: Plasma DTG Concentration Population
Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=12 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Unbound DTG Plasma Concentrations at Week 2 and Week 16
Week 2
|
17.1 Nanograms per milliliter (ng/mL)
Interval 10.3 to 24.0
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|
Unbound DTG Plasma Concentrations at Week 2 and Week 16
Week 16
|
23.9 Nanograms per milliliter (ng/mL)
Interval 3.81 to 32.1
|
PRIMARY outcome
Timeframe: Week 2 and Week 16Population: Plasma DTG Concentration Population
The unbound fraction of DTG in plasma (presented as a percentage of unbound \[i.e., free DTG not bound to cellular proteins\] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=12 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Plasma DTG Unbound Fraction at Week 2 and Week 16
Week 2
|
0.488 Percentage
Interval 0.333 to 0.655
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Plasma DTG Unbound Fraction at Week 2 and Week 16
Week 16
|
0.701 Percentage
Interval 0.488 to 4.3
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PRIMARY outcome
Timeframe: Week 2 and Week 16Population: CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.
CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=12 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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DTG Concentrations in CSF at Weeks 2 and Week 16
Week 2, n=11
|
18.2 Nanograms per milliliter (ng/mL)
Interval 4.0 to 23.2
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|
DTG Concentrations in CSF at Weeks 2 and Week 16
Week 16, n=12
|
13.2 Nanograms per milliliter (ng/mL)
Interval 3.7 to 18.3
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SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, 12, and 16Population: Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product
HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
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|---|---|
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Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Baseline
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0 participants
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Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Week 2
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4 participants
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|
Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Week 4
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6 participants
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|
Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Week 8
|
8 participants
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Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Week 12
|
10 participants
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Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Week 16
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96Population: ITT-E Population. Only those participants available at the indicated time point were assessed.
The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Baseline, n=13
|
4.73 log10 copies/mL
Interval 3.6 to 6.57
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 2, n=12
|
2.05 log10 copies/mL
Interval 1.59 to 2.99
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 2, n=12
|
-2.53 log10 copies/mL
Interval -3.7 to -2.01
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 4, n=12
|
1.67 log10 copies/mL
Interval 1.59 to 2.49
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 4, n=12
|
-3.04 log10 copies/mL
Interval -4.08 to -2.01
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute Value, Week 8, n=12
|
1.59 log10 copies/mL
Interval 1.59 to 2.48
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 8, n=12
|
-3.10 log10 copies/mL
Interval -4.09 to -2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 12, n=12
|
1.59 log10 copies/mL
Interval 1.59 to 2.36
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 12, n=12
|
-3.04 log10 copies/mL
Interval -4.2 to -2.01
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 16, n=12
|
1.59 log10 copies/mL
Interval 1.59 to 2.37
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 16, n=12
|
-3.04 log10 copies/mL
Interval -4.19 to -2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute Value, Week 24, n=12
|
1.59 log10 copies/mL
Interval 1.59 to 2.21
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 24, n=12
|
-3.11 log10 copies/mL
Interval -4.35 to -2.01
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Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 36, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 1.62
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 36, n=11
|
-3.08 log10 copies/mL
Interval -3.89 to -2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 48, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 2.1
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 48, n=11
|
-3.00 log10 copies/mL
Interval -3.78 to -2.01
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|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 60, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 2.19
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 60, n=11
|
-3.00 log10 copies/mL
Interval -3.89 to -2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 72, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 72, n=11
|
-3.08 log10 copies/mL
Interval -3.78 to -2.01
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 84, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 1.72
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 84, n=11
|
-3.08 log10 copies/mL
Interval -3.89 to -1.88
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute value, Week 96, n=11
|
1.59 log10 copies/mL
Interval 1.59 to 3.05
|
|
Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline, Week 96, n=11
|
-3.08 log10 copies/mL
Interval -3.78 to -0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 16Population: CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.
The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA \<50 copies/milliliter (c/mL).
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16
Baseline, n=13
|
1 participants
|
|
Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16
Week 2, n=12
|
7 participants
|
|
Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16
Week 16, n=11
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 16Population: CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.
The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Absolute value, Baseline, n=13
|
3.64 log10 c/mL
Interval 1.46 to 5.6
|
|
Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Absolute value, Week 2, n=12
|
0.98 log10 c/mL
Interval 0.0 to 3.3
|
|
Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Change from Baseline, Week 2, n=12
|
-2.19 log10 c/mL
Interval -3.11 to -1.29
|
|
Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Absolute value, Week 16, n=11
|
0.00 log10 c/mL
Interval 0.0 to 0.7
|
|
Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Change from Baseline, Week 16, n=11
|
-3.42 log10 c/mL
Interval -5.6 to -1.46
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 16Population: CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.
The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of \<50 copies/mL in plasma, \<50 copies/mL in CSF, \>=50 copies/mL in plasma, and \>=50 copies/mL in CSF at Baseline, Week 2, and Week 16.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Baseline, CSF<50 c/mL, Plasma<50 c/mL, n=13
|
0 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Baseline, CSF<50 c/mL, Plasma>=50 c/mL, n=13
|
1 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Baseline, CSF>=50 c/mL, Plasma<50 c/mL, n=13
|
0 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Baseline, CSF>=50 c/mL, Plasma>=50 c/mL, n=13
|
12 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 2, CSF<50 c/mL, Plasma<50 c/mL, n=12
|
4 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 2, CSF<50 c/mL, Plasma>=50 c/mL, n=12
|
3 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 2, CSF>=50 c/mL, Plasma<50 c/mL, n=12
|
0 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 2, CSF>=50 c/mL, Plasma>=50 c/mL, n=12
|
5 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 16, CSF<50 c/mL, Plasma<50 c/mL, n=11
|
9 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 16, CSF<50 c/mL, Plasma>=50 c/mL, n=11
|
2 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 16, CSF>=50 c/mL, Plasma<50 c/mL, n=11
|
0 participants
|
|
Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Week 16, CSF>=50 c/mL, Plasma>=50 c/mL, n=11
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 16Population: CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.
The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=11 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Week 2, Absolute Log10 CSF HIV-1 RNA, n=11
|
0.567 Pearson Correlation Coefficient
Interval 0.062 to 0.841
|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Week 2, CFB Log10 CSF HIV-1, n=11
|
0.007 Pearson Correlation Coefficient
Interval -0.518 to 0.529
|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Week 16, Absolute Log10 CSF HIV-1 RNA, n=11
|
-0.775 Pearson Correlation Coefficient
Interval -0.924 to -0.423
|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Week 16, CFB Log10 CSF HIV-1, n=11
|
-0.354 Pearson Correlation Coefficient
Interval -0.74 to 0.209
|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Overall, Absolute Log10 CSF HIV-1 RNA, n=11
|
0.517 Pearson Correlation Coefficient
Interval 0.193 to 0.74
|
|
Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Overall, CFB Log10 CSF HIV-1, n=11
|
0.106 Pearson Correlation Coefficient
Interval -0.265 to 0.449
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96Population: ITT-E Population. Only those participants available at the indicated time point were assessed.
The absolute value for CD4+ cell count (cells per millimeters cubed \[mm\^3\]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Baseline, n=13
|
260 cells/mm^3
Interval 152.0 to 863.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 4, n=12
|
578 cells/mm^3
Interval 374.0 to 903.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 8, n=12
|
645 cells/mm^3
Interval 364.0 to 1118.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 12, n=12
|
589 cells/mm^3
Interval 303.0 to 1144.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 16, n=12
|
573 cells/mm^3
Interval 436.0 to 1156.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 24, n=12
|
634 cells/mm^3
Interval 448.0 to 1339.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week (Wk) 36, n=11
|
706 cells/mm^3
Interval 534.0 to 1351.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 48, n=11
|
666 cells/mm^3
Interval 537.0 to 939.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 60, n=11
|
702 cells/mm^3
Interval 567.0 to 1266.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 72, n=11
|
823 cells/mm^3
Interval 620.0 to 1315.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 84, n=11
|
907 cells/mm^3
Interval 512.0 to 1341.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Absolute CD4+ cell count, Week 96, n=11
|
843 cells/mm^3
Interval 339.0 to 1436.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Week 4, n=12
|
162 cells/mm^3
Interval -158.0 to 365.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Week 8, n=12
|
247 cells/mm^3
Interval 44.0 to 551.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 12, n=12
|
263 cells/mm^3
Interval -17.0 to 500.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 16, n=12
|
226 cells/mm^3
Interval -248.0 to 629.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 24, n=12
|
264 cells/mm^3
Interval 86.0 to 762.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 36, n=11
|
480 cells/mm^3
Interval 174.0 to 774.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 48, n=11
|
311 cells/mm^3
Interval -80.0 to 541.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 60, n=11
|
382 cells/mm^3
Interval 5.0 to 708.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 72, n=11
|
519 cells/mm^3
Interval 260.0 to 651.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 84, n=11
|
543 cells/mm^3
Interval 94.0 to 792.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Change from Baseline CD4+ cell count, Wk 96, n=11
|
467 cells/mm^3
Interval -65.0 to 859.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, 16, 24, 48, and 96Population: ITT-E Population. Only those participants available at the indicated time point were assessed.
The absolute value for CD48+ cell count (cells per millimeters cubed \[mm\^3\]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Baseline, n=13
|
757 cells/mm^3
Interval 276.0 to 2945.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 4, n=12
|
874 cells/mm^3
Interval 542.0 to 1984.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 12, n=12
|
865 cells/mm^3
Interval 419.0 to 1472.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 16, n=12
|
706 cells/mm^3
Interval 478.0 to 1818.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 24, n=11
|
876 cells/mm^3
Interval 434.0 to 1634.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 48, n=11
|
708 cells/mm^3
Interval 530.0 to 1318.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Absolute CD8+ cell count, Week 96, n=11
|
842 cells/mm^3
Interval 249.0 to 1582.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count, Week 4, n=12
|
104 cells/mm^3
Interval -1123.0 to 1060.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count,Week 12, n=11
|
-53 cells/mm^3
Interval -1627.0 to 631.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count,Week 16, n=11
|
-35 cells/mm^3
Interval -1614.0 to 684.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count,Week 24, n=11
|
235 cells/mm^3
Interval -418.0 to 710.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count,Week 48, n=11
|
106 cells/mm^3
Interval -747.0 to 441.0
|
|
Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Change from Baseline CD8+ cell count,Week 96, n=11
|
85 cells/mm^3
Interval -424.0 to 677.0
|
SECONDARY outcome
Timeframe: Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)Population: ITT-E Population
The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences
New CDC Category B event
|
0 participants
|
|
Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences
Recurring CDC Category B event
|
0 participants
|
|
Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences
New CDC Category C event
|
0 participants
|
|
Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences
Recurring CDC Category C event
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)Population: Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms \[ECGs\], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities
Any AE
|
13 participants
|
|
The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities
Clinical chemistry toxicities
|
12 participants
|
|
The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities
Hematology toxicities
|
3 participants
|
|
The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities
Abnormal ECG (clinically significant)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through the date the last participant completed Week 96Population: Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor \[IN\] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF
The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.
Outcome measures
| Measure |
Dolutegravir 50 mg OD
n=13 Participants
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)
Treatment-emergent genotypic resistance
|
0 participants
|
|
Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)
Treatment-emergent phenotypic resistance
|
0 participants
|
Adverse Events
Dolutegravir 50 mg OD
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dolutegravir 50 mg OD
n=13 participants at risk
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Hepatobiliary disorders
Cholecystitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Other adverse events
| Measure |
Dolutegravir 50 mg OD
n=13 participants at risk
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
|
|---|---|
|
Infections and infestations
Folliculitis
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Pharyngitis
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
38.5%
5/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Anal chlamydia infection
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Influenza
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Oral herpes
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Otitis externa
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Syphilis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Tooth abscess
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Headache
|
53.8%
7/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Food poisoning
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
23.1%
3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
General disorders
Fatigue
|
23.1%
3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
General disorders
Hunger
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
23.1%
3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Eye disorders
Eye pruritus
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
23.1%
3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Investigations
Weight increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Psychiatric disorders
Sleep disorder
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Acarodermatitis
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Conjunctivitis
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Herpes simplex
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Body tinea
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Chlamydial infection
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Gonorrhoea
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Sciatica
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
23.1%
3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
General disorders
Impaired healing
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Investigations
Lipase increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Psychiatric disorders
Emotional disorder
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Psychiatric disorders
Libido decreased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Renal and urinary disorders
Urine flow decreased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Reproductive system and breast disorders
Prostatitis
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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