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Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

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ClinicalTrials.gov Identifier: NCT02121795
Recruitment Status : Completed
First Posted : April 24, 2014
Results First Posted : November 30, 2016
Last Update Posted : March 12, 2020
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/TDF
Drug: F/TAF
Drug: Allowed third antiretroviral agent
Drug: FTC/TDF Placebo
Drug: F/TAF Placebo
Enrollment 668
Recruitment Details Participants were enrolled at study sites in North America and Europe. The first participant was screened on 06 May 2014. The last study visit occurred on 1 March 2019.
Pre-assignment Details 780 participants were screened.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description

Double-Blind Phase: emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.

Open-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program.

Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.

Open-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program.

Period Title: Double-Blind Phase
Started 334 334
Safety Analysis Set 333 330
Completed 296 300
Not Completed 38 34
Reason Not Completed
Randomized but Never Treated             1             4
Withdrawal by Subject             19             16
Lost to Follow-up             7             4
Physician Decision             2             5
Adverse Event             5             0
Non-Compliance with Study Drug             3             1
Protocol Violation             0             3
Death             1             1
Period Title: Open-Label Phase
Started 33 [1] 31 [1]
Completed 21 21
Not Completed 12 10
Reason Not Completed
Physician Decision             8             8
Withdrawal by Subject             3             2
Lost to Follow-up             1             0
[1]
Not all participants entered the Open-Label Phase.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent Total
Hide Arm/Group Description Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks. Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 333 330 663
Hide Baseline Analysis Population Description
The Safety Analysis Set included all randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants 330 participants 663 participants
47  (9.9) 48  (9.7) 48  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
Female
48
  14.4%
54
  16.4%
102
  15.4%
Male
285
  85.6%
276
  83.6%
561
  84.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
Hispanic or Latino
48
  14.4%
78
  23.6%
126
  19.0%
Not Hispanic or Latino
285
  85.6%
252
  76.4%
537
  81.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
American Indian or Alaska Native 2 1 3
Asian 6 0 6
Black 69 67 136
Native Hawaiian or Pacific Islander 2 1 3
White 244 253 497
Not Permitted 1 1 2
Other 9 7 16
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
Canada 5 9 14
Belgium 3 3 6
United States 282 274 556
Italy 2 6 8
United Kingdom 23 17 40
France 18 21 39
Baseline Third Agent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
Atazanavir boosted with ritonavir (ATV/r) 53 50 103
Darunavir boosted with ritonavir (DRV/r) 84 82 166
Lopinavir boosted with ritonavir (LPV/r) 18 18 36
Dolutegravir (DTG) 26 23 49
Efavirenz (EFV) 8 6 14
Maraviroc (MVC) 1 6 7
Nevirapine (NVP) 74 66 140
Raltegravir (RAL) 66 73 139
Rilpivirine (RPV) 3 6 9
HIV-1 RNA Categories  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 333 participants 330 participants 663 participants
< 50 copies/mL 329 326 655
>= 50 copies/mL 4 4 8
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 333 participants 330 participants 663 participants
691  (272.6) 667  (272.3) 679  (272.5)
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
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 participant's virologic response 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
The Full Analysis Set included all participants who were randomized into the study and received at least one dose of study drug.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 333 330
Measure Type: Number
Unit of Measure: percentage of participants
94.3 93.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF + 3rd Agent, FTC/TDF + 3rd Agent
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95.002%
-2.5 to 5.1
Estimation Comments Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.
2.Secondary Outcome
Title Percentage 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; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline hip BMD data) with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 304 305
Mean (Standard Deviation)
Unit of Measure: percentage change
1.236  (2.6602) -0.071  (2.3316)
3.Secondary Outcome
Title Percentage Change From Baseline in Spine BMD at Week 48
Hide Description Spine BMD was assessed by DXA scan.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline spine BMD data) with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 304 309
Mean (Standard Deviation)
Unit of Measure: percentage change
1.662  (3.1279) -0.109  (3.3476)
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 333 330
Measure Type: Number
Unit of Measure: percentage of participants
91.6 90.9
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; 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 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 313 311
Mean (Standard Deviation)
Unit of Measure: cells/μL
20  (161.8) 21  (152.7)
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 333 330
Measure Type: Number
Unit of Measure: percentage of participants
83.5 86.1
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 333 330
Measure Type: Number
Unit of Measure: percentage of participants
88.6 89.1
8.Secondary Outcome
Title Percentage Change From Baseline in Hip BMD at Week 96
Hide Description Hip BMD was assessed by DXA scan.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 291 292
Mean (Standard Deviation)
Unit of Measure: percentage change
1.856  (3.2195) -0.289  (2.9912)
9.Secondary Outcome
Title Percentage Change From Baseline in Spine BMD at Week 96
Hide Description Spine BMD was assessed by DXA scan.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 290 296
Mean (Standard Deviation)
Unit of Measure: percentage change
2.159  (3.8374) -0.109  (3.6738)
10.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.
Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 299 296
Mean (Standard Deviation)
Unit of Measure: cells/μL
50  (198.7) 46  (169.4)
Time Frame First dose of study drug to the last dose (maximum: 227.4 weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included all randomized participants who received at least one dose of study drug.
 
Arm/Group Title F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
Hide Arm/Group Description Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg tablet) + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks. Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks. Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group. Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.
All-Cause Mortality
F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/333 (0.60%)   1/330 (0.30%)   0/33 (0.00%)   0/31 (0.00%) 
Hide Serious Adverse Events
F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/333 (8.71%)   31/330 (9.39%)   2/33 (6.06%)   3/31 (9.68%) 
Cardiac disorders         
Myocardial infarction  1  0/333 (0.00%)  0/330 (0.00%)  0/33 (0.00%)  1/31 (3.23%) 
Ventricular extrasystoles  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Abdominal pain upper  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Chronic gastritis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Colitis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Constipation  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Diarrhoea  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Haematemesis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Haemorrhoids  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Intestinal stenosis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Intestinal ulcer  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Obstructive pancreatitis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Oesophageal stenosis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Pancreatitis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Pancreatitis acute  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
General disorders         
Chest pain  1  2/333 (0.60%)  1/330 (0.30%)  1/33 (3.03%)  0/31 (0.00%) 
Drowning  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Mucosal inflammation  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  1/333 (0.30%)  2/330 (0.61%)  0/33 (0.00%)  0/31 (0.00%) 
Cholelithiasis  1  1/333 (0.30%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Cholelithiasis obstructive  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Infections and infestations         
Acute hepatitis C  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Arthritis bacterial  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Bone tuberculosis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Diverticulitis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Enteritis infectious  1  0/333 (0.00%)  0/330 (0.00%)  0/33 (0.00%)  1/31 (3.23%) 
Escherichia urinary tract infection  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Gastrointestinal infection  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Herpes zoster  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Influenza  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Laryngitis  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Localised infection  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Lung infection  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Mycobacterium abscessus infection  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Oesophagitis bacterial  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Pneumonia  1  0/333 (0.00%)  3/330 (0.91%)  0/33 (0.00%)  0/31 (0.00%) 
Prostatitis Escherichia coli  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Pyelonephritis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Subcutaneous abscess  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Injury, poisoning and procedural complications         
Alcohol poisoning  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Anastomotic stenosis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Ankle fracture  1  0/333 (0.00%)  2/330 (0.61%)  0/33 (0.00%)  0/31 (0.00%) 
Limb injury  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Overdose  1  1/333 (0.30%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Investigations         
Lipase increased  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Fluid overload  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/333 (0.00%)  0/330 (0.00%)  0/33 (0.00%)  1/31 (3.23%) 
Arthritis  1  0/333 (0.00%)  0/330 (0.00%)  0/33 (0.00%)  1/31 (3.23%) 
Back pain  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Intervertebral disc protrusion  1  3/333 (0.90%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Neck pain  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Osteoarthritis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Rhabdomyolysis  1  2/333 (0.60%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung adenocarcinoma  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Lymphoma  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Metastases to lung  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Metastases to lymph nodes  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Tonsil cancer  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Nervous system disorders         
Carotid artery stenosis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Dizziness exertional  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Encephalopathy  1  0/333 (0.00%)  2/330 (0.61%)  0/33 (0.00%)  0/31 (0.00%) 
Headache  1  1/333 (0.30%)  2/330 (0.61%)  0/33 (0.00%)  0/31 (0.00%) 
Loss of consciousness  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Syncope  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Psychiatric disorders         
Alcoholism  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Delirium  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Depressed mood  1  0/333 (0.00%)  0/330 (0.00%)  1/33 (3.03%)  0/31 (0.00%) 
Depression  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Suicide attempt  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Renal colic  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  1/333 (0.30%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Dyspnoea  1  1/333 (0.30%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Pleural effusion  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Pneumonia aspiration  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Pneumothorax  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Pulmonary embolism  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Respiratory failure  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
Vascular disorders         
Aortic aneurysm  1  0/333 (0.00%)  1/330 (0.30%)  0/33 (0.00%)  0/31 (0.00%) 
Venous thrombosis limb  1  1/333 (0.30%)  0/330 (0.00%)  0/33 (0.00%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   242/333 (72.67%)   226/330 (68.48%)   12/33 (36.36%)   13/31 (41.94%) 
Gastrointestinal disorders         
Diarrhoea  1  44/333 (13.21%)  42/330 (12.73%)  1/33 (3.03%)  0/31 (0.00%) 
Nausea  1  23/333 (6.91%)  19/330 (5.76%)  0/33 (0.00%)  0/31 (0.00%) 
General disorders         
Fatigue  1  26/333 (7.81%)  23/330 (6.97%)  0/33 (0.00%)  0/31 (0.00%) 
Influenza like illness  1  6/333 (1.80%)  10/330 (3.03%)  0/33 (0.00%)  2/31 (6.45%) 
Pyrexia  1  6/333 (1.80%)  17/330 (5.15%)  0/33 (0.00%)  0/31 (0.00%) 
Infections and infestations         
Bronchitis  1  32/333 (9.61%)  26/330 (7.88%)  1/33 (3.03%)  1/31 (3.23%) 
Fungal skin infection  1  1/333 (0.30%)  2/330 (0.61%)  0/33 (0.00%)  2/31 (6.45%) 
Gastroenteritis  1  11/333 (3.30%)  8/330 (2.42%)  2/33 (6.06%)  0/31 (0.00%) 
Influenza  1  23/333 (6.91%)  15/330 (4.55%)  0/33 (0.00%)  2/31 (6.45%) 
Nasopharyngitis  1  43/333 (12.91%)  27/330 (8.18%)  4/33 (12.12%)  2/31 (6.45%) 
Onychomycosis  1  6/333 (1.80%)  3/330 (0.91%)  0/33 (0.00%)  3/31 (9.68%) 
Sinusitis  1  23/333 (6.91%)  28/330 (8.48%)  2/33 (6.06%)  3/31 (9.68%) 
Syphilis  1  18/333 (5.41%)  7/330 (2.12%)  3/33 (9.09%)  2/31 (6.45%) 
Upper respiratory tract infection  1  54/333 (16.22%)  67/330 (20.30%)  1/33 (3.03%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  35/333 (10.51%)  23/330 (6.97%)  0/33 (0.00%)  2/31 (6.45%) 
Back pain  1  37/333 (11.11%)  28/330 (8.48%)  3/33 (9.09%)  2/31 (6.45%) 
Pain in extremity  1  26/333 (7.81%)  22/330 (6.67%)  0/33 (0.00%)  0/31 (0.00%) 
Nervous system disorders         
Headache  1  33/333 (9.91%)  22/330 (6.67%)  0/33 (0.00%)  1/31 (3.23%) 
Psychiatric disorders         
Anxiety  1  15/333 (4.50%)  20/330 (6.06%)  2/33 (6.06%)  1/31 (3.23%) 
Insomnia  1  15/333 (4.50%)  13/330 (3.94%)  0/33 (0.00%)  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  37/333 (11.11%)  20/330 (6.06%)  2/33 (6.06%)  2/31 (6.45%) 
Skin and subcutaneous tissue disorders         
Rash  1  19/333 (5.71%)  11/330 (3.33%)  1/33 (3.03%)  0/31 (0.00%) 
Vascular disorders         
Hypertension  1  16/333 (4.80%)  20/330 (6.06%)  0/33 (0.00%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
Indicates events were collected by systematic assessment
There were no limitations affecting the analysis or results.
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
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02121795    
Other Study ID Numbers: GS-US-311-1089
2013-005138-39 ( EudraCT Number )
First Submitted: April 22, 2014
First Posted: April 24, 2014
Results First Submitted: August 11, 2016
Results First Posted: November 30, 2016
Last Update Posted: March 12, 2020