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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 : Active, not recruiting
First Posted : April 24, 2014
Results First Posted : November 30, 2016
Last Update Posted : January 10, 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/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 Week 48 study visit occurred on 12 August 2015.
Pre-assignment Details 780 participants were screened.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description 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 FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
Period Title: Overall Study
Started 334 334
Completed 0 0
Not Completed 334 334
Reason Not Completed
Randomized but Never Treated             1             4
Adverse Event             4             0
Investigator's Discretion             1             0
Non-Compliance with Study Drug             1             1
Protocol Violation             0             2
Withdrew Consent             10             10
Lost to Follow-up             2             1
Still in Study up to the Data Cut Date             315             316
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent Total
Hide Arm/Group Description 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 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
Safety Analysis Set: 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 [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
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
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
Show Statistical Analysis 1 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 or Equivalence
Comments Noninferiority was assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Cochran-Mantel-Haenszel test
Comments P-value for the superiority test comparing the percentages of virologic success was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.
Method of Estimation Estimation Parameter Difference in percentages
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 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; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
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
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 300 303
Mean (Standard Deviation)
Unit of Measure: percentage of change in hip BMD (g/cm^2)
1.135  (2.7526) -0.152  (2.5317)
3.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
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
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 300 306
Mean (Standard Deviation)
Unit of Measure: percentage change in spine BMD (g/cm^2)
1.527  (3.1816) -0.206  (3.2233)
4.Secondary Outcome
Title Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description:
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
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
Show Outcome Measure DataHide 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:
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
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 Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percent Change From Baseline in Hip and Spine BMD at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Outcome Measure Data Not Reported
Time Frame Up to the Week 48 Data Cut
Adverse Event Reporting Description Safety analysis set: all randomized participants who received at least one dose of study drug.
 
Arm/Group Title F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Hide Arm/Group Description 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 FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
All-Cause Mortality
F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Affected / at Risk (%) Affected / at Risk (%)
Total   18/333 (5.41%)   14/330 (4.24%) 
Gastrointestinal disorders     
Abdominal pain upper  1  1/333 (0.30%)  0/330 (0.00%) 
Diarrhoea  1  1/333 (0.30%)  0/330 (0.00%) 
Haematemesis  1  1/333 (0.30%)  0/330 (0.00%) 
Haemorrhoids  1  0/333 (0.00%)  1/330 (0.30%) 
Intestinal stenosis  1  0/333 (0.00%)  1/330 (0.30%) 
Intestinal ulcer  1  0/333 (0.00%)  1/330 (0.30%) 
Pancreatitis  1  0/333 (0.00%)  1/330 (0.30%) 
General disorders     
Chest pain  1  1/333 (0.30%)  0/330 (0.00%) 
Mucosal inflammation  1  1/333 (0.30%)  0/330 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/333 (0.30%)  1/330 (0.30%) 
Cholelithiasis  1  0/333 (0.00%)  1/330 (0.30%) 
Infections and infestations     
Arthritis bacterial  1  0/333 (0.00%)  1/330 (0.30%) 
Diverticulitis  1  0/333 (0.00%)  1/330 (0.30%) 
Gastrointestinal infection  1  1/333 (0.30%)  0/330 (0.00%) 
Herpes zoster  1  1/333 (0.30%)  0/330 (0.00%) 
Mycobacterium abscessus infection  1  1/333 (0.30%)  0/330 (0.00%) 
Oesophagitis bacterial  1  0/333 (0.00%)  1/330 (0.30%) 
Pyelonephritis  1  0/333 (0.00%)  1/330 (0.30%) 
Subcutaneous abscess  1  0/333 (0.00%)  1/330 (0.30%) 
Injury, poisoning and procedural complications     
Anastomotic stenosis  1  0/333 (0.00%)  1/330 (0.30%) 
Limb injury  1  1/333 (0.30%)  0/330 (0.00%) 
Overdose  1  1/333 (0.30%)  1/330 (0.30%) 
Investigations     
Lipase increased  1  1/333 (0.30%)  0/330 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/333 (0.30%)  0/330 (0.00%) 
Fluid overload  1  0/333 (0.00%)  1/330 (0.30%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/333 (0.30%)  0/330 (0.00%) 
Intervertebral disc protrusion  1  2/333 (0.60%)  0/330 (0.00%) 
Osteoarthritis  1  1/333 (0.30%)  0/330 (0.00%) 
Rhabdomyolysis  1  1/333 (0.30%)  0/330 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma  1  1/333 (0.30%)  0/330 (0.00%) 
Tonsil cancer  1  1/333 (0.30%)  0/330 (0.00%) 
Nervous system disorders     
Dizziness exertional  1  1/333 (0.30%)  0/330 (0.00%) 
Encephalopathy  1  0/333 (0.00%)  1/330 (0.30%) 
Headache  1  1/333 (0.30%)  1/330 (0.30%) 
Loss of consciousness  1  1/333 (0.30%)  0/330 (0.00%) 
Syncope  1  1/333 (0.30%)  0/330 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/333 (0.00%)  1/330 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/333 (0.00%)  1/330 (0.30%) 
Pulmonary embolism  1  0/333 (0.00%)  1/330 (0.30%) 
Respiratory failure  1  0/333 (0.00%)  1/330 (0.30%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/333 (0.30%)  0/330 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
F/TAF + 3rd Agent FTC/TDF + 3rd Agent
Affected / at Risk (%) Affected / at Risk (%)
Total   150/333 (45.05%)   139/330 (42.12%) 
Gastrointestinal disorders     
Diarrhoea  1  29/333 (8.71%)  33/330 (10.00%) 
General disorders     
Fatigue  1  18/333 (5.41%)  13/330 (3.94%) 
Infections and infestations     
Bronchitis  1  21/333 (6.31%)  17/330 (5.15%) 
Nasopharyngitis  1  25/333 (7.51%)  20/330 (6.06%) 
Sinusitis  1  12/333 (3.60%)  22/330 (6.67%) 
Upper respiratory tract infection  1  30/333 (9.01%)  45/330 (13.64%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/333 (5.71%)  9/330 (2.73%) 
Back pain  1  20/333 (6.01%)  15/330 (4.55%) 
Nervous system disorders     
Headache  1  26/333 (7.81%)  14/330 (4.24%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  21/333 (6.31%)  16/330 (4.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02121795     History of Changes
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: January 10, 2019