Trial Outcomes & Findings for Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults (NCT NCT01440569)
NCT ID: NCT01440569
Last Updated: 2016-12-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2016-12-14
Participant Flow
Participants were enrolled at a total of 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015.
397 participants were screened.
Participant milestones
| Measure |
Treatment-Naive
Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Main Study
STARTED
|
296
|
18
|
|
Main Study
Enrolled and Treated
|
295
|
18
|
|
Main Study
COMPLETED
|
260
|
14
|
|
Main Study
NOT COMPLETED
|
36
|
4
|
|
Open-Label Rollover Phase
STARTED
|
251
|
13
|
|
Open-Label Rollover Phase
COMPLETED
|
204
|
7
|
|
Open-Label Rollover Phase
NOT COMPLETED
|
47
|
6
|
Reasons for withdrawal
| Measure |
Treatment-Naive
Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Main Study
Enrolled but not treated
|
1
|
0
|
|
Main Study
Adverse Event
|
9
|
0
|
|
Main Study
Pregnancy
|
1
|
0
|
|
Main Study
Investigator's Discretion
|
1
|
1
|
|
Main Study
Withdrew Consent
|
7
|
1
|
|
Main Study
Lost to Follow-up
|
13
|
2
|
|
Main Study
Subject Non-Compliance
|
3
|
0
|
|
Main Study
Protocol Violation
|
1
|
0
|
|
Open-Label Rollover Phase
Adverse Event
|
3
|
0
|
|
Open-Label Rollover Phase
Pregnancy
|
1
|
0
|
|
Open-Label Rollover Phase
Lack of Efficacy
|
2
|
0
|
|
Open-Label Rollover Phase
Investigator's Discretion
|
3
|
1
|
|
Open-Label Rollover Phase
Withdrew Consent
|
11
|
1
|
|
Open-Label Rollover Phase
Lost to Follow-up
|
26
|
3
|
|
Open-Label Rollover Phase
Subject Non-Compliance
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
Baseline characteristics by cohort
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
45 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
36 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Gender
Female
|
29 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Gender
Male
|
266 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
231 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
176 participants
n=5 Participants
|
11 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
101 participants
n=5 Participants
|
7 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
CD4 Count (cells/mm^3)
|
378.2 cells/mm^3
STANDARD_DEVIATION 199.94 • n=5 Participants
|
197.8 cells/mm^3
STANDARD_DEVIATION 214.30 • n=7 Participants
|
367.8 cells/mm^3
STANDARD_DEVIATION 204.79 • n=5 Participants
|
|
HIV-1 RNA (log10 copies/mL)
|
4.8 log10 copies/mL
STANDARD_DEVIATION 0.76 • n=5 Participants
|
4.8 log10 copies/mL
STANDARD_DEVIATION 1.04 • n=7 Participants
|
4.8 log10 copies/mL
STANDARD_DEVIATION 0.78 • n=5 Participants
|
|
Background Antiretroviral Regimen
FTC/TDF
|
291 participants
n=5 Participants
|
10 participants
n=7 Participants
|
301 participants
n=5 Participants
|
|
Background Antiretroviral Regimen
AZT+FTC/TDF
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Background Antiretroviral Regimen
ABC+TDF
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Background Antiretroviral Regimen
ABC+FTC/TDF
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Background Antiretroviral Regimen
ABC/3TC
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Background Antiretroviral Regimen
DDI+FTC
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24
|
5.4 percentage of participants
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)
|
83.7 percentage of participants
|
61.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)
|
82.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
145 cells/μL
Standard Deviation 131.6
|
99 cells/μL
Standard Deviation 161.9
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
194 cells/µL
Standard Deviation 152.1
|
121 cells/µL
Standard Deviation 157.0
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24
Any treatment-emergent adverse event (TEAE)
|
88.1 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24
Any TEAE that led to study drug discontinuation
|
5.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
Treatment-Naive
n=295 Participants
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 Participants
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48
Any treatment-emergent adverse event (TEAE)
|
91.5 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48
Any TEAE that led to study drug discontinuation
|
5.4 percentage of participants
|
0 percentage of participants
|
Adverse Events
Treatment-Naive
Serious events: 45 serious events
Other events: 261 other events
Deaths: 0 deaths
Treatment-Experienced
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-Naive
n=295 participants at risk
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 participants at risk
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Cardiac disorders
Acute myocardial infarction
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Eye disorders
Retinal detachment
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Odynophagia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Hypothermia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Pain
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Hepatobiliary disorders
Bile duct stone
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Immune system disorders
Hypersensitivity
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Appendicitis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
1.7%
5/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Furuncle
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Gangrene
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Lung abscess
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Osteomyelitis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Perirectal abscess
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pilonidal cyst
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Alcoholism
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Suicidal ideation
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Suicide attempt
|
1.4%
4/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Priapism
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
Other adverse events
| Measure |
Treatment-Naive
n=295 participants at risk
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
Treatment-Experienced
n=18 participants at risk
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
10/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
23/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.4%
4/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
13/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
4.4%
13/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
33.6%
99/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
44.4%
8/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
18/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.5%
22/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
27.1%
80/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Tongue pigmentation
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
3.1%
9/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
34/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Chest pain
|
4.1%
12/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Fatigue
|
11.9%
35/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
General disorders
Pyrexia
|
7.1%
21/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Immune system disorders
Seasonal allergy
|
5.1%
15/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Acarodermatitis
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
11.2%
33/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Conjunctivitis
|
5.4%
16/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Folliculitis
|
5.4%
16/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
6/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Herpes zoster
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
6.8%
20/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
37/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
22.2%
4/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Onychomycosis
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Pharyngitis
|
8.1%
24/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Rash pustular
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
11.2%
33/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
22.2%
4/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Syphilis
|
8.5%
25/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Tooth abscess
|
3.4%
10/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
23.7%
70/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Vaginal infection
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.4%
4/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
1.7%
5/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Investigations
Weight decreased
|
1.4%
4/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.4%
10/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
20/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
23/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.0%
3/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
6.8%
20/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile wart
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Amnesia
|
1.0%
3/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
16.9%
50/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Abnormal dreams
|
4.1%
12/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
6.4%
19/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
12.5%
37/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
6.1%
18/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Renal and urinary disorders
Dysuria
|
2.0%
6/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
3/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.7%
8/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Uterine malposition
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
27/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
20/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.0%
3/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.7%
8/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
5/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.8%
17/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.1%
12/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.4%
7/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
13/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.2%
39/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
5/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.68%
2/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
16.7%
3/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
3/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
11.1%
2/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Surgical and medical procedures
Tooth extraction
|
0.34%
1/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
5.6%
1/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
5.8%
17/295 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
0.00%
0/18 • Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Safety Analysis Set
|
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