Trial Outcomes & Findings for Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection (NCT NCT00445146)
NCT ID: NCT00445146
Last Updated: 2016-04-25
Results Overview
COMPLETED
PHASE2
192 participants
Up to Week 408 plus 30 days
2016-04-25
Participant Flow
Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.
Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.
Participant milestones
| Measure |
EVG+RTV
Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Overall Study
STARTED
|
192
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
119
|
Reasons for withdrawal
| Measure |
EVG+RTV
Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Overall Study
Withdrew Consent
|
29
|
|
Overall Study
Lack of Efficacy
|
28
|
|
Overall Study
Investigator's Discretion
|
22
|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Death
|
9
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Pregnancy
|
1
|
Baseline Characteristics
Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
Baseline characteristics by cohort
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
139 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
48 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 408 plus 30 daysPopulation: Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
|
14.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 408 plus 30 daysPopulation: Safety Analysis Set
Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Any AE
|
93.8 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Grade 3 or 4 AE
|
45.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Grade 3 or 4 Drug-related AE
|
3.1 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Serious AE
|
44.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 408 plus 30 daysPopulation: Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Grade 1
|
18.3 percentage of participants
|
|
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Grade 2
|
31.9 percentage of participants
|
|
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Grade 3
|
35.1 percentage of participants
|
|
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Grade 4
|
14.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 408 plus 30 daysPopulation: Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.
A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality
|
40.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
14.2 g/dL
Standard Deviation 1.86
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 165)
|
0.1 g/dL
Standard Deviation 1.01
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 151)
|
0.3 g/dL
Standard Deviation 1.12
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 139)
|
0.2 g/dL
Standard Deviation 1.44
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 118)
|
0.2 g/dL
Standard Deviation 1.40
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 106)
|
0.3 g/dL
Standard Deviation 1.36
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 91)
|
0.2 g/dL
Standard Deviation 1.54
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 84)
|
0.3 g/dL
Standard Deviation 1.79
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 78)
|
0.3 g/dL
Standard Deviation 1.49
|
|
Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 70)
|
0.4 g/dL
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
4.6 10^6 cells/μL
Standard Deviation 0.65
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 165)
|
0.0 10^6 cells/μL
Standard Deviation 0.37
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 151)
|
0.0 10^6 cells/μL
Standard Deviation 0.35
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 139)
|
0.0 10^6 cells/μL
Standard Deviation 0.45
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 118)
|
0.0 10^6 cells/μL
Standard Deviation 0.50
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 106)
|
0.0 10^6 cells/μL
Standard Deviation 0.48
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 91)
|
0.0 10^6 cells/μL
Standard Deviation 0.55
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 84)
|
0.0 10^6 cells/μL
Standard Deviation 0.55
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 78)
|
0.0 10^6 cells/μL
Standard Deviation 0.44
|
|
Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 70)
|
0.0 10^6 cells/μL
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
5.64 10^3 cells/μL
Standard Deviation 2.074
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 165)
|
0.02 10^3 cells/μL
Standard Deviation 1.670
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 151)
|
0.12 10^3 cells/μL
Standard Deviation 1.899
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 139)
|
-0.17 10^3 cells/μL
Standard Deviation 1.761
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 118)
|
-0.25 10^3 cells/μL
Standard Deviation 1.948
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 106)
|
-0.19 10^3 cells/μL
Standard Deviation 2.072
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 91)
|
-0.09 10^3 cells/μL
Standard Deviation 2.082
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 84)
|
-0.21 10^3 cells/μL
Standard Deviation 2.091
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 78)
|
-0.35 10^3 cells/μL
Standard Deviation 1.961
|
|
White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 70)
|
-0.28 10^3 cells/μL
Standard Deviation 1.759
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 187)
|
226 10^3 cells/µL
Standard Deviation 75.0
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 154)
|
2 10^3 cells/µL
Standard Deviation 47.3
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 148)
|
5 10^3 cells/µL
Standard Deviation 49.5
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 134)
|
13 10^3 cells/µL
Standard Deviation 59.4
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 114)
|
3 10^3 cells/µL
Standard Deviation 48.7
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 103)
|
-2 10^3 cells/µL
Standard Deviation 53.8
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 88)
|
6 10^3 cells/µL
Standard Deviation 45.7
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 80)
|
6 10^3 cells/µL
Standard Deviation 60.9
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 76)
|
-6 10^3 cells/µL
Standard Deviation 61.0
|
|
Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 70)
|
-15 10^3 cells/µL
Standard Deviation 56.8
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 192)
|
101 U/L
Standard Deviation 43.3
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 170)
|
-6 U/L
Standard Deviation 26.8
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 156)
|
-9 U/L
Standard Deviation 31.0
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 143)
|
-9 U/L
Standard Deviation 28.9
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 122)
|
-13 U/L
Standard Deviation 27.8
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 110)
|
-18 U/L
Standard Deviation 27.7
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 95)
|
-17 U/L
Standard Deviation 29.2
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 86)
|
-20 U/L
Standard Deviation 29.3
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 80)
|
-19 U/L
Standard Deviation 31.3
|
|
Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 72)
|
-20 U/L
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 191)
|
28 U/L
Standard Deviation 16.6
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 169)
|
2 U/L
Standard Deviation 16.3
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 154)
|
1 U/L
Standard Deviation 17.5
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 141)
|
2 U/L
Standard Deviation 19.4
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 120)
|
2 U/L
Standard Deviation 18.6
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 109)
|
1 U/L
Standard Deviation 16.2
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 94)
|
0 U/L
Standard Deviation 18.0
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 85)
|
3 U/L
Standard Deviation 17.0
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 79)
|
3 U/L
Standard Deviation 22.9
|
|
Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 71)
|
1 U/L
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 185)
|
29 U/L
Standard Deviation 14.5
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 163)
|
2 U/L
Standard Deviation 13.4
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 150)
|
0 U/L
Standard Deviation 13.5
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 137)
|
2 U/L
Standard Deviation 16.2
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 116)
|
1 U/L
Standard Deviation 14.5
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 105)
|
-1 U/L
Standard Deviation 12.4
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 91)
|
0 U/L
Standard Deviation 16.3
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 82)
|
1 U/L
Standard Deviation 12.8
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 76)
|
1 U/L
Standard Deviation 13.2
|
|
Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 68)
|
1 U/L
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
2.70 log10 copies/mL
Standard Deviation 1.337
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 174)
|
-0.13 log10 copies/mL
Standard Deviation 0.795
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 158)
|
-0.20 log10 copies/mL
Standard Deviation 0.892
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 142)
|
-0.11 log10 copies/mL
Standard Deviation 0.963
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 123)
|
-0.22 log10 copies/mL
Standard Deviation 0.998
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 110)
|
-0.21 log10 copies/mL
Standard Deviation 1.043
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 96)
|
-0.15 log10 copies/mL
Standard Deviation 0.955
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 86)
|
-0.34 log10 copies/mL
Standard Deviation 1.066
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 82)
|
-0.70 log10 copies/mL
Standard Deviation 1.055
|
|
HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 73)
|
-0.68 log10 copies/mL
Standard Deviation 1.029
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
65.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 24 (n = 175)
|
69.7 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 48 (n = 159)
|
78.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 96 (n = 142)
|
76.8 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 144 (n = 123)
|
82.9 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 192 (n = 110)
|
84.5 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 240 (n = 96)
|
89.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 288 (n = 86)
|
95.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 336 (n = 82)
|
95.1 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 384 (n = 73)
|
93.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 190)
|
44.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 24 (n = 175)
|
56.0 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 48 (n = 159)
|
62.9 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 96 (n = 142)
|
65.5 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 144 (n = 123)
|
73.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 192 (n = 110)
|
79.1 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 240 (n = 96)
|
78.1 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 288 (n = 86)
|
89.5 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 336 (n = 82)
|
86.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Week 384 (n = 73)
|
90.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384Population: Participants in the Efficacy Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG+RTV
n=191 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Baseline (n = 189)
|
283 cells/mm^3
Standard Deviation 211.8
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 24 (n = 168)
|
22 cells/mm^3
Standard Deviation 98.9
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 48 (n = 152)
|
38 cells/mm^3
Standard Deviation 119.5
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 96 (n = 138)
|
78 cells/mm^3
Standard Deviation 132.3
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 144 (n = 118)
|
126 cells/mm^3
Standard Deviation 177.0
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 192 (n = 106)
|
149 cells/mm^3
Standard Deviation 167.5
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 240 (n = 93)
|
176 cells/mm^3
Standard Deviation 198.1
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 288 (n = 84)
|
205 cells/mm^3
Standard Deviation 210.8
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 336 (n = 80)
|
225 cells/mm^3
Standard Deviation 206.8
|
|
CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384
Change at Week 384 (n = 71)
|
234 cells/mm^3
Standard Deviation 214.4
|
SECONDARY outcome
Timeframe: Up to Week 408 plus 30 daysPopulation: Safety Analysis Set
The percentage of participants who died was summarized.
Outcome measures
| Measure |
EVG+RTV
n=192 Participants
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Incidence of Mortality
|
6.8 percentage of participants
|
Adverse Events
EVG+RTV
Serious adverse events
| Measure |
EVG+RTV
n=192 participants at risk
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
3/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Aortic valve stenosis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
5/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Atrial flutter
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Cardiomyopathy
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Congestive cardiomyopathy
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Coronary artery disease
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
4/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Ear and labyrinth disorders
Vertigo
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Eye disorders
Necrotising retinitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Colitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Diarrhoea
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Oesophagitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Vomiting
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
General disorders
Chest pain
|
1.6%
3/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
General disorders
Perforated ulcer
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
General disorders
Pyrexia
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Hepatobiliary disorders
Cholecystitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Immune system disorders
Serum sickness-like reaction
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Anal abscess
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Appendicitis
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Aspergillus infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Bronchitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Cellulitis
|
2.6%
5/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Diabetic foot infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Gastroenteritis
|
2.1%
4/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
HIV infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
HIV wasting syndrome
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Herpes zoster
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Herpes zoster disseminated
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Influenza
|
1.6%
3/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Listeriosis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Localised infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Meningitis aseptic
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Meningitis cryptococcal
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Oesophageal candidiasis
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pneumonia
|
4.7%
9/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pneumonia streptococcal
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Prostatic abscess
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pseudomembranous colitis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pyelonephritis
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pyelonephritis acute
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Secondary syphilis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Sepsis
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Sinusitis aspergillus
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Subcutaneous abscess
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Urethritis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Urinary tract infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Viral infection
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Viral pericarditis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Investigations
Weight decreased
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
4/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Gout
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.1%
4/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.6%
3/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Ataxia
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Cerebrovascular accident
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Cervical radiculopathy
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Parkinson's disease
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Presyncope
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Seizure
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Syncope
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Transient ischaemic attack
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Confusional state
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Depression
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Homicidal ideation
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Major depression
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Mental disorder
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Mental status changes
|
2.1%
4/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Suicidal ideation
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Suicide attempt
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
5/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Renal and urinary disorders
Renal failure
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Renal and urinary disorders
Renal impairment
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Aortic stenosis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
3/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Hypertension
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Hypertensive crisis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Hypotension
|
1.0%
2/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Venous stenosis
|
0.52%
1/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
Other adverse events
| Measure |
EVG+RTV
n=192 participants at risk
EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.9%
17/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Endocrine disorders
Hypogonadism
|
5.7%
11/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
12/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Constipation
|
6.8%
13/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Diarrhoea
|
25.5%
49/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.5%
22/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Nausea
|
16.7%
32/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
16/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
General disorders
Fatigue
|
15.1%
29/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
General disorders
Pyrexia
|
8.9%
17/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Immune system disorders
Seasonal allergy
|
5.2%
10/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Bronchitis
|
20.8%
40/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Cellulitis
|
8.3%
16/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Folliculitis
|
6.2%
12/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Herpes simplex
|
5.2%
10/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Influenza
|
9.9%
19/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Nasopharyngitis
|
17.7%
34/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Onychomycosis
|
5.7%
11/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Otitis media
|
6.2%
12/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Pharyngitis
|
7.8%
15/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Sinusitis
|
26.0%
50/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Upper respiratory tract infection
|
32.3%
62/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Urinary tract infection
|
7.8%
15/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Infections and infestations
Viral infection
|
5.7%
11/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Investigations
Weight decreased
|
7.3%
14/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
14/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.2%
10/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
26/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
33/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
13/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.8%
15/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
24/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
8.3%
16/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
9.9%
19/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Dizziness
|
5.2%
10/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Headache
|
12.5%
24/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Nervous system disorders
Neuropathy peripheral
|
6.8%
13/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Anxiety
|
11.5%
22/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Depression
|
17.7%
34/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Psychiatric disorders
Insomnia
|
13.0%
25/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.2%
10/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.3%
14/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.2%
33/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
11/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
13/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
14/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.3%
14/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.7%
11/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
15/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
|
Vascular disorders
Hypertension
|
8.3%
16/192 • Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
|
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