Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (NCT NCT01106586)
NCT ID: NCT01106586
Last Updated: 2015-11-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
708 participants
Primary outcome timeframe
Week 48
Results posted on
2015-11-11
Participant Flow
Participants were enrolled at 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last study visit occurred on 18 September 2014.
1017 subjects were screened.
Participant milestones
| Measure |
Stribild
Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
|
ATV/r + FTC/TDF
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
355
|
|
Overall Study
COMPLETED
|
68
|
70
|
|
Overall Study
NOT COMPLETED
|
285
|
285
|
Reasons for withdrawal
| Measure |
Stribild
Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
|
ATV/r + FTC/TDF
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
15
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Pregnancy
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Investigator's Discretion
|
5
|
8
|
|
Overall Study
Withdrew Consent
|
18
|
30
|
|
Overall Study
Lost to Follow-up
|
24
|
20
|
|
Overall Study
Participant Noncompliance
|
12
|
10
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Participant Transferred to Another Study
|
212
|
197
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
39 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
38 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
324 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
640 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
72 participants
n=5 Participants
|
47 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
250 participants
n=5 Participants
|
277 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
197 participants
n=5 Participants
|
185 participants
n=7 Participants
|
382 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
France
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
36 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HIV Disease Status
Asymptomatic
|
285 participants
n=5 Participants
|
293 participants
n=7 Participants
|
578 participants
n=5 Participants
|
|
HIV Disease Status
Symptomatic HIV Infections
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
HIV Disease Status
AIDS
|
32 participants
n=5 Participants
|
24 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Hepatitis B Virus (HBV) Infection Status
Negative
|
347 participants
n=5 Participants
|
346 participants
n=7 Participants
|
693 participants
n=5 Participants
|
|
Hepatitis B Virus (HBV) Infection Status
Positive
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Hepatitis B Virus (HBV) Infection Status
Indeterminate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Hepatitis B Virus (HBV) Infection Status
Not done
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) Infection Status
Negative
|
335 participants
n=5 Participants
|
344 participants
n=7 Participants
|
679 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) Infection Status
Positive
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) Infection Status
Indeterminate
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) Infection Status
Not done
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HIV-1 RNA Category (copies/mL)
≤ 100,000 copies/mL
|
203 participants
n=5 Participants
|
214 participants
n=7 Participants
|
417 participants
n=5 Participants
|
|
HIV-1 RNA Category (copies/mL)
> 100,000 copies/mL
|
150 participants
n=5 Participants
|
141 participants
n=7 Participants
|
291 participants
n=5 Participants
|
|
CD4 Cell Count (/µL)
≤ 50 μL
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
CD4 Cell Count (/µL)
51 to ≤ 200 μL
|
42 participants
n=5 Participants
|
34 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
CD4 Cell Count (/µL)
201 to ≤ 350 μL
|
122 participants
n=5 Participants
|
124 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
CD4 Cell Count (/µL)
351 to ≤ 500 μL
|
122 participants
n=5 Participants
|
122 participants
n=7 Participants
|
244 participants
n=5 Participants
|
|
CD4 Cell Count (/µL)
> 500 μL
|
55 participants
n=5 Participants
|
70 participants
n=7 Participants
|
125 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
|
89.5 percentage of participants
|
86.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: ITT Analysis Set
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
|
83.3 percentage of participants
|
82.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: ITT Analysis Set
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
|
77.6 percentage of participants
|
74.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.
Outcome measures
| Measure |
Stribild
n=74 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=78 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192
|
78.4 percentage of participants
|
73.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT analysis set
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
|
86.1 percentage of participants
|
84.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, and 192Population: ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.
Change = value of the relevant time point minus the baseline value
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Change at Wk 48 (Stribild, n=334; ATV/r, n=321)
|
207 cells/µL
Standard Deviation 164.2
|
211 cells/µL
Standard Deviation 160.3
|
|
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Change at Wk 96 (Stribild, n=317; ATV/r, n=315)
|
256 cells/µL
Standard Deviation 166.8
|
261 cells/µL
Standard Deviation 188.0
|
|
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Change at Wk 144 (Stribild, n=297; ATV/r, n=286)
|
280 cells/µL
Standard Deviation 159.8
|
293 cells/µL
Standard Deviation 211.5
|
|
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Change at Wk 192 (Stribild, n=69; ATV/r, n=72)
|
338 cells/µL
Standard Deviation 186.8
|
340 cells/µL
Standard Deviation 224.2
|
SECONDARY outcome
Timeframe: Week 48Population: ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).
Outcome measures
| Measure |
Stribild
n=353 Participants
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 Participants
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
|
91.5 percentage of participants
|
88.5 percentage of participants
|
Adverse Events
Stribild
Serious events: 58 serious events
Other events: 326 other events
Deaths: 0 deaths
ATV/r + FTC/TDF
Serious events: 62 serious events
Other events: 326 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stribild
n=353 participants at risk
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 participants at risk
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Congenital, familial and genetic disorders
Congenital ureteric anomaly
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
1.1%
4/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diverticulum
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
General disorders
Chest pain
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Immune system disorders
Drug hypersensitivity
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Abscess limb
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Abscess neck
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Anal abscess
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.85%
3/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Appendicitis
|
0.85%
3/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Appendicitis perforated
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Arthritis infective
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Breast abscess
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Device related infection
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Ear infection
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Epididymitis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Impetigo
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Incision site infection
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Infectious colitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Malaria
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Malignant syphilis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Orchitis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Osteomyelitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Peritonitis
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pneumonia bacterial
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pneumonia streptococcal
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Salpingitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Secondary syphilis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Septic shock
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Shigella infection
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Staphylococcal infection
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Viral infection
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage II
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Cervical radiculopathy
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Coma
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Convulsion
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Syncope
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Tension headache
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depression
|
0.85%
3/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Drug dependence
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Major depression
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Mania
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Schizophrenia
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Suicidal ideation
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Suicide attempt
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.56%
2/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Hydronephrosis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.28%
1/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Peripheral embolism
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Thrombophlebitis
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Venous thrombosis limb
|
0.28%
1/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
0.00%
0/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
Other adverse events
| Measure |
Stribild
n=353 participants at risk
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
|
ATV/r + FTC/TDF
n=355 participants at risk
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.5%
23/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
4.5%
16/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Eye disorders
Ocular icterus
|
0.57%
2/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
14.6%
52/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
25/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
7.3%
26/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
5.7%
20/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
3.9%
14/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
28.0%
99/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
34.1%
121/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
13/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.4%
19/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
16/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
9.0%
32/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
22.7%
80/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
22.0%
78/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
26/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
9.9%
35/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
17.0%
60/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
16.9%
60/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
6.5%
23/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
6.2%
22/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
9.6%
34/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Immune system disorders
Seasonal allergy
|
4.8%
17/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.4%
19/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
13.3%
47/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
11.8%
42/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Chlamydial infection
|
5.1%
18/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
4.8%
17/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Folliculitis
|
5.4%
19/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
6.2%
22/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
5.1%
18/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
7.9%
28/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Herpes zoster
|
4.2%
15/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.6%
20/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
8.8%
31/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
6.8%
24/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
53/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
16.1%
57/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Onychomycosis
|
5.9%
21/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
3.7%
13/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis
|
6.5%
23/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.1%
18/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Sinusitis
|
9.9%
35/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
10.7%
38/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Syphilis
|
7.6%
27/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
8.2%
29/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
24.4%
86/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
27.3%
97/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
5.1%
18/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.6%
20/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
14/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.4%
19/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.9%
21/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.4%
19/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
35/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
9.0%
32/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
46/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
10.4%
37/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
22/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.9%
21/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anorectal human papilloma virus infection
|
5.9%
21/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
3.4%
12/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
7.1%
25/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
7.9%
28/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
19.0%
67/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
15.5%
55/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
2.5%
9/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.9%
21/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Anxiety
|
6.2%
22/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
8.2%
29/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depression
|
13.3%
47/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
14.6%
52/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
10.5%
37/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
10.1%
36/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
38/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
13.0%
46/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
19/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
9.0%
32/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.8%
10/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
5.1%
18/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
30/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
10.4%
37/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
|
Vascular disorders
Hypertension
|
6.8%
24/353 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
3.4%
12/355 • Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER