Trial Outcomes & Findings for Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults (NCT NCT01967940)
NCT ID: NCT01967940
Last Updated: 2018-11-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
Day 10
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the United States, Uganda, Thailand, Russian Federation, and Dominican Republic. The first participant was screened on 25 October 2013. The last study visit occurred on 31 July 2017.
259 participants were screened.
Participant milestones
| Measure |
Part 1 Sentinel Cohort TAF
Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
Part 2 E/C/F/TAF + ATV
Following a 14 day washout period, participants from the Randomized Cohort TAF group who had a \> 0.5 log10 decline in HIV-1 RNA and participants from the Randomized Cohort Placebo group were eligible to receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks. After completion of Part 2, all participants were eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF became commercially available, or until Gilead Sciences terminated development of E/C/F/TAF in the applicable country.
|
|---|---|---|---|---|
|
Part 1
STARTED
|
12
|
28
|
15
|
0
|
|
Part 1
COMPLETED
|
12
|
28
|
15
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
38
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
35
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part 1 Sentinel Cohort TAF
Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
Part 2 E/C/F/TAF + ATV
Following a 14 day washout period, participants from the Randomized Cohort TAF group who had a \> 0.5 log10 decline in HIV-1 RNA and participants from the Randomized Cohort Placebo group were eligible to receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks. After completion of Part 2, all participants were eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF became commercially available, or until Gilead Sciences terminated development of E/C/F/TAF in the applicable country.
|
|---|---|---|---|---|
|
Part 2
Enrolled in Part 2 and Never Treated
|
0
|
0
|
0
|
1
|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
1
|
|
Part 2
Unknown Reason
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
Baseline characteristics by cohort
| Measure |
Part 1 Sentinel Cohort TAF
n=12 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
n=28 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
n=15 Participants
Placebo once daily + their current failing regimen for 10 days
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
40 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
43 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
40 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Dominican Republic
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Uganda
|
0 participants
n=5 Participants
|
19 participants
n=7 Participants
|
9 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
HIV-1 RNA
|
4.18 log10 copies/mL
STANDARD_DEVIATION 0.648 • n=5 Participants
|
4.16 log10 copies/mL
STANDARD_DEVIATION 0.544 • n=7 Participants
|
4.03 log10 copies/mL
STANDARD_DEVIATION 0.953 • n=5 Participants
|
4.13 log10 copies/mL
STANDARD_DEVIATION 0.688 • n=4 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
HIV-1 RNA Category
> 100,000 to ≤ 400,000 copies/mL
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
CD4 Cell Count
|
269 cells/µL
STANDARD_DEVIATION 207.1 • n=5 Participants
|
245 cells/µL
STANDARD_DEVIATION 244.6 • n=7 Participants
|
232 cells/µL
STANDARD_DEVIATION 162.4 • n=5 Participants
|
246 cells/µL
STANDARD_DEVIATION 213.7 • n=4 Participants
|
|
CD4 Percentage
|
17.4 percentage
STANDARD_DEVIATION 10.14 • n=5 Participants
|
16.5 percentage
STANDARD_DEVIATION 11.09 • n=7 Participants
|
14.3 percentage
STANDARD_DEVIATION 8.61 • n=5 Participants
|
16.1 percentage
STANDARD_DEVIATION 10.15 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 10Population: Part 1 Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=12 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
n=28 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
n=15 Participants
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
|
58.3 percentage of participants
|
60.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Day 10Population: Part 1 Full Analysis Set
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=12 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
n=28 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
n=15 Participants
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
|
-0.72 log10 copies/mL
Standard Deviation 0.574
|
-0.70 log10 copies/mL
Standard Deviation 0.628
|
-0.04 log10 copies/mL
Standard Deviation 0.233
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Part 2 Safety Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24
|
37.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Part 2 Safety Analysis Set
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48
|
48.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Part 2 Safety Analysis Set
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24
|
75.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Part 2 Safety Analysis Set
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48
|
81.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Part 2 Full Analysis Set
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
|
86.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Part 2 Full Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
|
97.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Part 2 Full Analysis Set
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
|
94.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Part 2 Full Analysis Set
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=37 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
|
97.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24
|
-2.96 log10 copies/mL
Standard Deviation 0.754
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48
|
-3.04 log10 copies/mL
Standard Deviation 0.594
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in CD4+ Cell Count at Week 24
|
76 cells/μL
Standard Deviation 92.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in CD4+ Cell Count at Week 48
|
125 cells/μL
Standard Deviation 109.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in CD4+ Percentage at Week 24
|
4.4 percentage change
Standard Deviation 2.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Part 2 Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1 Sentinel Cohort TAF
n=35 Participants
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
Placebo once daily + their current failing regimen for 10 days
|
|---|---|---|---|
|
Part 2: Change From Baseline in CD4+ Percentage at Week 48
|
5.7 percentage change
Standard Deviation 2.99
|
—
|
—
|
Adverse Events
Part 1 Sentinel Cohort TAF
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1 Randomized Cohort TAF
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Randomized Cohort Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 E/C/F/TAF + ATV
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Sentinel Cohort TAF
n=12 participants at risk
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
n=28 participants at risk
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
n=15 participants at risk
Placebo once daily + their current failing regimen for 10 days
|
Part 2 E/C/F/TAF + ATV
n=37 participants at risk
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks plus the extension phase
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
Other adverse events
| Measure |
Part 1 Sentinel Cohort TAF
n=12 participants at risk
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort TAF
n=28 participants at risk
TAF 25 mg tablet once daily + their current failing regimen for 10 days
|
Part 1 Randomized Cohort Placebo
n=15 participants at risk
Placebo once daily + their current failing regimen for 10 days
|
Part 2 E/C/F/TAF + ATV
n=37 participants at risk
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks plus the extension phase
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
8.1%
3/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
8.1%
3/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
8.1%
3/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
8.1%
3/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Malaria
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
13.5%
5/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Pyuria
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
29.7%
11/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
10.8%
4/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
3.6%
1/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
8.1%
3/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eosinophilic cellulitis
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
5.4%
2/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
0.00%
0/28 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
6.7%
1/15 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
2.7%
1/37 • Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER