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Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

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ClinicalTrials.gov Identifier: NCT01967940
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : June 12, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Acquired Immunodeficiency Syndrome
Interventions Drug: TAF
Drug: Placebo
Drug: E/C/F/TAF
Drug: Current failing ARV regimen
Drug: ATV
Enrollment 55
Recruitment Details Participants were enrolled at study sites in the United States, Uganda, Thailand, Russian Federation, and Dominican Republic. The first participant was screened on 25 October 2013. The last study visit occurred on 31 July 2017.
Pre-assignment Details 259 participants were screened.
Arm/Group Title Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days TAF 25 mg tablet once daily + their current failing regimen for 10 days Placebo once daily + their current failing regimen for 10 days Following a 14 day washout period, participants from the Randomized Cohort TAF group who had a > 0.5 log10 decline in HIV-1 RNA and participants from the Randomized Cohort Placebo group were eligible to receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks. After completion of Part 2, all participants were eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF became commercially available, or until Gilead Sciences terminated development of E/C/F/TAF in the applicable country.
Period Title: Part 1
Started 12 28 15 0
Completed 12 28 15 0
Not Completed 0 0 0 0
Period Title: Part 2
Started 0 [1] 0 [2] 0 [3] 38 [4]
Completed 0 0 0 35
Not Completed 0 0 0 3
Reason Not Completed
Enrolled in Part 2 and Never Treated             0             0             0             1
Adverse Event             0             0             0             1
Unknown Reason             0             0             0             1
[1]
4 participants completed Part 1 and did not enter Part 2; 8 participants moved to the Part 2 group
[2]
12 participants completed Part 1 and did not enter Part 2; 16 participants moved to the Part 2 group
[3]
1 participant completed Part 1 and did not enter Part 2; 14 participants moved to the Part 2 group
[4]
38 participants from the Part 1 groups moved to this Part 2 E/C/F/TAF + ATV group
Arm/Group Title Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Total
Hide Arm/Group Description TAF 25 mg tablet once daily + their current failing regimen for 10 days TAF 25 mg tablet once daily + their current failing regimen for 10 days Placebo once daily + their current failing regimen for 10 days Total of all reporting groups
Overall Number of Baseline Participants 12 28 15 55
Hide Baseline Analysis Population Description
Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 28 participants 15 participants 55 participants
38  (7.3) 40  (9.1) 43  (8.2) 40  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 28 participants 15 participants 55 participants
Female
3
  25.0%
16
  57.1%
4
  26.7%
23
  41.8%
Male
9
  75.0%
12
  42.9%
11
  73.3%
32
  58.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 28 participants 15 participants 55 participants
Hispanic or Latino
5
  41.7%
0
   0.0%
1
   6.7%
6
  10.9%
Not Hispanic or Latino
7
  58.3%
28
 100.0%
14
  93.3%
49
  89.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 28 participants 15 participants 55 participants
Asian
0
   0.0%
5
  17.9%
5
  33.3%
10
  18.2%
Black
3
  25.0%
22
  78.6%
9
  60.0%
34
  61.8%
White
4
  33.3%
1
   3.6%
0
   0.0%
5
   9.1%
Other
5
  41.7%
0
   0.0%
1
   6.7%
6
  10.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 28 participants 15 participants 55 participants
Russian Federation 2 1 0 3
United States 5 3 0 8
Dominican Republic 5 0 1 6
Uganda 0 19 9 28
Thailand 0 5 5 10
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 12 participants 28 participants 15 participants 55 participants
4.18  (0.648) 4.16  (0.544) 4.03  (0.953) 4.13  (0.688)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 28 participants 15 participants 55 participants
≤ 100,000 copies/mL
12
 100.0%
27
  96.4%
12
  80.0%
51
  92.7%
> 100,000 to ≤ 400,000 copies/mL
0
   0.0%
1
   3.6%
3
  20.0%
4
   7.3%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 12 participants 28 participants 15 participants 55 participants
269  (207.1) 245  (244.6) 232  (162.4) 246  (213.7)
CD4 Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 12 participants 28 participants 15 participants 55 participants
17.4  (10.14) 16.5  (11.09) 14.3  (8.61) 16.1  (10.15)
1.Primary Outcome
Title Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
Hide Description [Not Specified]
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 1 Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.
Arm/Group Title Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo
Hide Arm/Group Description:
TAF 25 mg tablet once daily + their current failing regimen for 10 days
TAF 25 mg tablet once daily + their current failing regimen for 10 days
Placebo once daily + their current failing regimen for 10 days
Overall Number of Participants Analyzed 12 28 15
Measure Type: Number
Unit of Measure: percentage of participants
58.3 60.7 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1 Randomized Cohort TAF, Part 1 Randomized Cohort Placebo
Comments A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.
Type of Statistical Test Superiority
Comments Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 60.7
Confidence Interval (2-Sided) 95%
42.6 to 78.8
Estimation Comments The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.
2.Secondary Outcome
Title Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
Hide Description [Not Specified]
Time Frame Baseline; Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 1 Full Analysis Set
Arm/Group Title Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo
Hide Arm/Group Description:
TAF 25 mg tablet once daily + their current failing regimen for 10 days
TAF 25 mg tablet once daily + their current failing regimen for 10 days
Placebo once daily + their current failing regimen for 10 days
Overall Number of Participants Analyzed 12 28 15
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-0.72  (0.574) -0.70  (0.628) -0.04  (0.233)
3.Secondary Outcome
Title Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24
Hide Description [Not Specified]
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Safety Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
37.8
4.Secondary Outcome
Title Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48
Hide Description [Not Specified]
Time Frame Up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Safety Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
48.6
5.Secondary Outcome
Title Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24
Hide Description [Not Specified]
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Safety Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
75.7
6.Secondary Outcome
Title Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48
Hide Description [Not Specified]
Time Frame Up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Safety Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
81.1
7.Secondary Outcome
Title Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Full Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
86.5
8.Secondary Outcome
Title Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Full Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
97.3
9.Secondary Outcome
Title Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
Hide Description The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Full Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
94.6
10.Secondary Outcome
Title Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part 2 Full Analysis Set
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
97.3
11.Secondary Outcome
Title Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.96  (0.754)
12.Secondary Outcome
Title Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.04  (0.594)
13.Secondary Outcome
Title Part 2: Change From Baseline in CD4+ Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cells/μL
76  (92.8)
14.Secondary Outcome
Title Part 2: Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cells/μL
125  (109.0)
15.Secondary Outcome
Title Part 2: Change From Baseline in CD4+ Percentage at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: percentage change
4.4  (2.35)
16.Secondary Outcome
Title Part 2: Change From Baseline in CD4+ Percentage at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Part 2 Full Analysis Set with available data were analyzed.
Arm/Group Title Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: percentage change
5.7  (2.99)
Time Frame Baseline up to the last dose date plus 30 days (average exposure: Part 1 = 10 days; Part 2 = 86.5 weeks)
Adverse Event Reporting Description Safety Analysis Set: participants who enrolled into the study and received at least one dose of study drug.
 
Arm/Group Title Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Part 2 E/C/F/TAF + ATV
Hide Arm/Group Description TAF 25 mg tablet once daily + their current failing regimen for 10 days TAF 25 mg tablet once daily + their current failing regimen for 10 days Placebo once daily + their current failing regimen for 10 days E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks plus the extension phase
All-Cause Mortality
Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Part 2 E/C/F/TAF + ATV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/28 (0.00%)   0/15 (0.00%)   0/37 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Part 2 E/C/F/TAF + ATV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   3/28 (10.71%)   0/15 (0.00%)   4/37 (10.81%) 
Gastrointestinal disorders         
Enlarged uvula  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myopathy  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  0/37 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Vascular disorders         
Hypotension  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1 Sentinel Cohort TAF Part 1 Randomized Cohort TAF Part 1 Randomized Cohort Placebo Part 2 E/C/F/TAF + ATV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/12 (58.33%)   6/28 (21.43%)   5/15 (33.33%)   26/37 (70.27%) 
Blood and lymphatic system disorders         
Anaemia  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Gastrointestinal disorders         
Diarrhoea  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Haemorrhoids  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  0/37 (0.00%) 
Nausea  1  2/12 (16.67%)  1/28 (3.57%)  0/15 (0.00%)  0/37 (0.00%) 
Proctalgia  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  0/37 (0.00%) 
Toothache  1  0/12 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  3/37 (8.11%) 
General disorders         
Chest pain  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Malaise  1  0/12 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  1/37 (2.70%) 
Pyrexia  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  3/37 (8.11%) 
Jaundice  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  3/37 (8.11%) 
Infections and infestations         
Bacterial infection  1  0/12 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/37 (0.00%) 
Disseminated tuberculosis  1  0/12 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/37 (0.00%) 
Gastroenteritis  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Influenza  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  3/37 (8.11%) 
Malaria  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  5/37 (13.51%) 
Oral candidiasis  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Pyuria  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Tonsillitis  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Upper respiratory tract infection  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  11/37 (29.73%) 
Urinary tract infection  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Viral upper respiratory tract infection  1  0/12 (0.00%)  1/28 (3.57%)  0/15 (0.00%)  2/37 (5.41%) 
Injury, poisoning and procedural complications         
Epicondylitis  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  0/37 (0.00%) 
Limb injury  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Back pain  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Nervous system disorders         
Dizziness  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Headache  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  4/37 (10.81%) 
Neuropathy peripheral  1  0/12 (0.00%)  1/28 (3.57%)  1/15 (6.67%)  3/37 (8.11%) 
Psychiatric disorders         
Insomnia  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Renal and urinary disorders         
Nephrolithiasis  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  1/37 (2.70%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Dyspnoea  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  0/37 (0.00%) 
Oropharyngeal pain  1  0/12 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Skin and subcutaneous tissue disorders         
Eosinophilic cellulitis  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  0/37 (0.00%) 
Rash  1  1/12 (8.33%)  0/28 (0.00%)  0/15 (0.00%)  2/37 (5.41%) 
Vascular disorders         
Hypertension  1  0/12 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01967940     History of Changes
Other Study ID Numbers: GS-US-292-0117
2013-002830-19 ( EudraCT Number )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: May 9, 2017
Results First Posted: June 12, 2017
Last Update Posted: November 16, 2018