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Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

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ClinicalTrials.gov Identifier: NCT02345226
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : October 19, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: FTC/RPV/TAF
Drug: EFV/FTC/TDF Placebo
Drug: EFV/FTC/TDF
Drug: FTC/RPV/TAF Placebo
Enrollment 881
Recruitment Details Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last Week 48 study visit occurred on 29 June 2016.
Pre-assignment Details 974 participants were screened.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey®; FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet orally, with food once daily + efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla®; EFV/FTC/TDF) placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Period Title: Overall Study
Started 440 441
Completed 0 0
Not Completed 440 441
Reason Not Completed
Adverse Event             2             4
Death             1             0
Pregnancy             0             1
Lack of Efficacy             1             0
Investigator's Discretion             3             1
Non-Compliance with Study Drug             1             0
Withdrew Consent             18             16
Lost to Follow-up             7             6
Randomized but Never Treated             2             4
Still in Study up to the Data Cut Date             405             409
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF Total
Hide Arm/Group Description FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 438 437 875
Hide Baseline Analysis Population Description
Safety Analysis Set: all participants who (1) are randomized into the study and (2) have received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 438 participants 437 participants 875 participants
48  (9.8) 47  (10.5) 48  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
Female
373
  85.2%
390
  89.2%
763
  87.2%
Male
65
  14.8%
47
  10.8%
112
  12.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 438 participants 437 participants 875 participants
American Indian or Alaska Native
3
   0.7%
2
   0.5%
5
   0.6%
Asian
9
   2.1%
8
   1.8%
17
   1.9%
Black
118
  26.9%
120
  27.5%
238
  27.2%
Native Hawaiian or Pacific Islander
1
   0.2%
0
   0.0%
1
   0.1%
White
291
  66.4%
292
  66.8%
583
  66.6%
Not Permitted
6
   1.4%
3
   0.7%
9
   1.0%
Other
10
   2.3%
12
   2.7%
22
   2.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 438 participants 437 participants 875 participants
Hispanic or Latino
79
  18.0%
78
  17.8%
157
  17.9%
Not Hispanic or Latino
358
  81.7%
359
  82.2%
717
  81.9%
Not Permitted
1
   0.2%
0
   0.0%
1
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 438 participants 437 participants 875 participants
Canada
20
   4.6%
24
   5.5%
44
   5.0%
Belgium
3
   0.7%
4
   0.9%
7
   0.8%
United States
351
  80.1%
345
  78.9%
696
  79.5%
United Kingdom
4
   0.9%
11
   2.5%
15
   1.7%
France
7
   1.6%
6
   1.4%
13
   1.5%
Switzerland
6
   1.4%
5
   1.1%
11
   1.3%
Germany
33
   7.5%
27
   6.2%
60
   6.9%
Spain
14
   3.2%
15
   3.4%
29
   3.3%
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 438 participants 437 participants 875 participants
< 50 copies/mL
430
  98.2%
432
  98.9%
862
  98.5%
≥ 50 copies/mL
8
   1.8%
5
   1.1%
13
   1.5%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells//uL
Number Analyzed 438 participants 437 participants 875 participants
711  (292.3) 688  (263.5) 700  (278.4)
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
90.0 92.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TAF, EFV/FTC/TDF
Comments The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.
Type of Statistical Test Non-Inferiority
Comments A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.0
Confidence Interval (2-Sided) 95.001%
-5.9 to 1.8
Estimation Comments The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0.9
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 390 403
Mean (Standard Deviation)
Unit of Measure: cells/uL
23  (156.4) 12  (153.3)
6.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hide Description Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set (all randomized participants received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 347 367
Mean (Standard Deviation)
Unit of Measure: percentage change
1.279  (2.3800) -0.134  (2.4930)
8.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96
Hide Description Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Hide Description Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set (all randomized participants, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 351 369
Mean (Standard Deviation)
Unit of Measure: percentage change
1.645  (3.3198) -0.045  (2.9087)
10.Secondary Outcome
Title Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96
Hide Description Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48
Hide Description The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don’t have this symptom; 1 = It doesn’t bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 368 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (3.4) -1  (3.4)
12.Secondary Outcome
Title Change From Baseline in HIV Symptoms Index Score at Week 96
Hide Description The HIV symptom index score will be determined using a patient reported outcome questionnaire.
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
Time Frame Up to 48 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: all randomized participants who received at least one dose of study drug
 
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description FTC/RPV/TAF (200/25/25 mg) FDC tablet orally, with food once daily + EFV/FTC/TDF placebo tablet orally, on an empty stomach once daily at bedtime for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks EFV/FTC/TDF (600/200/300 mg) FDC tablet orally, on an empty stomach, once daily at bedtime + FTC/RPV/TAF placebo tablet orally, with food, once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
All-Cause Mortality
FTC/RPV/TAF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FTC/RPV/TAF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   24/438 (5.48%)   25/437 (5.72%) 
Blood and lymphatic system disorders     
Haemorrhagic anaemia † 1  0/438 (0.00%)  1/437 (0.23%) 
Cardiac disorders     
Angina pectoris † 1  0/438 (0.00%)  1/437 (0.23%) 
Atrial fibrillation † 1  1/438 (0.23%)  1/437 (0.23%) 
Cardiac arrest † 1  1/438 (0.23%)  0/437 (0.00%) 
Coronary artery disease † 1  2/438 (0.46%)  0/437 (0.00%) 
Myocardial infarction † 1  2/438 (0.46%)  0/437 (0.00%) 
Supraventricular tachycardia † 1  0/438 (0.00%)  1/437 (0.23%) 
Gastrointestinal disorders     
Abdominal pain † 1  0/438 (0.00%)  1/437 (0.23%) 
Incarcerated inguinal hernia † 1  0/438 (0.00%)  1/437 (0.23%) 
General disorders     
Chest pain † 1  0/438 (0.00%)  1/437 (0.23%) 
Hepatobiliary disorders     
Cholecystitis † 1  1/438 (0.23%)  0/437 (0.00%) 
Cholelithiasis † 1  2/438 (0.46%)  0/437 (0.00%) 
Infections and infestations     
Abscess † 1  1/438 (0.23%)  0/437 (0.00%) 
Appendicitis † 1  0/438 (0.00%)  1/437 (0.23%) 
Cellulitis † 1  1/438 (0.23%)  0/437 (0.00%) 
Cellulitis orbital † 1  0/438 (0.00%)  1/437 (0.23%) 
Cellulitis staphylococcal † 1  1/438 (0.23%)  0/437 (0.00%) 
Diverticulitis † 1  1/438 (0.23%)  0/437 (0.00%) 
Gastroenteritis † 1  1/438 (0.23%)  0/437 (0.00%) 
Gastrointestinal infection † 1  0/438 (0.00%)  1/437 (0.23%) 
Localised infection † 1  1/438 (0.23%)  0/437 (0.00%) 
Necrotising fasciitis † 1  1/438 (0.23%)  0/437 (0.00%) 
Orchitis † 1  0/438 (0.00%)  1/437 (0.23%) 
Osteomyelitis † 1  0/438 (0.00%)  1/437 (0.23%) 
Parotitis † 1  0/438 (0.00%)  1/437 (0.23%) 
Pneumonia † 1  1/438 (0.23%)  2/437 (0.46%) 
Scrotal infection † 1  0/438 (0.00%)  1/437 (0.23%) 
Sepsis † 1  1/438 (0.23%)  0/437 (0.00%) 
Injury, poisoning and procedural complications     
Fibula fracture † 1  1/438 (0.23%)  0/437 (0.00%) 
Multiple fractures † 1  1/438 (0.23%)  0/437 (0.00%) 
Overdose † 1  1/438 (0.23%)  1/437 (0.23%) 
Post procedural complication † 1  0/438 (0.00%)  1/437 (0.23%) 
Road traffic accident † 1  1/438 (0.23%)  0/437 (0.00%) 
Wound † 1  1/438 (0.23%)  0/437 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis † 1  0/438 (0.00%)  1/437 (0.23%) 
Pathological fracture † 1  1/438 (0.23%)  0/437 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Laryngeal papilloma † 1  1/438 (0.23%)  0/437 (0.00%) 
Lymphoma † 1  0/438 (0.00%)  1/437 (0.23%) 
Metastases to bone † 1  1/438 (0.23%)  0/437 (0.00%) 
Prostate cancer † 1  1/438 (0.23%)  1/437 (0.23%) 
Nervous system disorders     
Aphasia † 1  1/438 (0.23%)  0/437 (0.00%) 
Carotid artery stenosis † 1  1/438 (0.23%)  0/437 (0.00%) 
Syncope † 1  1/438 (0.23%)  0/437 (0.00%) 
Transient ischaemic attack † 1  1/438 (0.23%)  1/437 (0.23%) 
Psychiatric disorders     
Alcohol abuse † 1  0/438 (0.00%)  1/437 (0.23%) 
Bipolar II disorder † 1  1/438 (0.23%)  0/437 (0.00%) 
Drug abuse † 1  0/438 (0.00%)  1/437 (0.23%) 
Mental status changes † 1  1/438 (0.23%)  0/437 (0.00%) 
Suicide attempt † 1  0/438 (0.00%)  1/437 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/438 (0.23%)  1/437 (0.23%) 
Chronic obstructive pulmonary disease † 1  0/438 (0.00%)  1/437 (0.23%) 
Surgical and medical procedures     
Knee arthroplasty † 1  1/438 (0.23%)  0/437 (0.00%) 
Vascular disorders     
Aortic dissection † 1  0/438 (0.00%)  1/437 (0.23%) 
Peripheral artery aneurysm † 1  1/438 (0.23%)  0/437 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TAF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   144/438 (32.88%)   122/437 (27.92%) 
Gastrointestinal disorders     
Diarrhoea † 1  21/438 (4.79%)  32/437 (7.32%) 
Infections and infestations     
Nasopharyngitis † 1  34/438 (7.76%)  19/437 (4.35%) 
Upper respiratory tract infection † 1  44/438 (10.05%)  42/437 (9.61%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  20/438 (4.57%)  24/437 (5.49%) 
Nervous system disorders     
Headache † 1  24/438 (5.48%)  17/437 (3.89%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  26/438 (5.94%)  15/437 (3.43%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02345226     History of Changes
Other Study ID Numbers: GS-US-366-1160
2014-004779-21 ( EudraCT Number )
First Submitted: January 19, 2015
First Posted: January 26, 2015
Results First Submitted: September 21, 2017
Results First Posted: October 19, 2017
Last Update Posted: March 6, 2019