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Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

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ClinicalTrials.gov Identifier: NCT02345252
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : December 8, 2017
Last Update Posted : January 2, 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/RPV/TAF
Drug: FTC/RPV/TDF Placebo
Drug: FTC/RPV/TDF
Drug: FTC/RPV/TAF Placebo
Enrollment 632
Recruitment Details Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 09 January 2019.
Pre-assignment Details 690 participants were screened.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description

Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks.

Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.

Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.

Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.

Period Title: Double-Blind Phase
Started 316 316
Completed 276 267
Not Completed 40 49
Reason Not Completed
Adverse Event             2             3
Death             1             2
Lack of Efficacy             1             0
Investigator's Discretion             4             6
Non-Compliance with Study Drug             1             2
Protocol Violation             2             1
Withdrew Consent             21             23
Lost to Follow-up             8             10
Randomized but Never Treated             0             2
Period Title: Open-Label Extension Phase
Started 19 [1] 17 [2]
Completed 19 17
Not Completed 0 0
[1]
257 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
[2]
250 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF Total
Hide Arm/Group Description FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks. FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 316 314 630
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 314 participants 630 participants
45  (10.4) 44  (10.2) 45  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
Female 41 25 66
Male 275 289 564
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
American Indian or Alaska Native 1 2 3
Asian 7 17 24
Black 65 54 119
Native Hawaiian or Pacific Islander 0 1 1
White 238 235 473
Other 5 5 10
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
Hispanic or Latino 40 53 93
Not Hispanic or Latino 275 261 536
Not Permitted 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
Canada 24 11 35
Netherlands 3 4 7
Sweden 2 2 4
Belgium 5 4 9
United States 222 226 448
Italy 3 8 11
United Kingdom 10 9 19
France 1 1 2
Switzerland 4 4 8
Germany 27 30 57
Spain 15 15 30
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
< 50 copies/mL 307 312 619
≥ 50 copies/mL 9 2 11
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/μL
Number Analyzed 316 participants 314 participants 630 participants
711  (278.9) 707  (264.7) 709  (271.7)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
≥ 50 to < 200 cells/µL 5 1 6
≥ 200 to < 350 cells/µL 10 16 26
≥ 350 to < 500 cells/µL 52 50 102
≥ 500 cells/ µL 249 247 496
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 US FDA-defined 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
The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on FTC/RPV/TDF prior to the screening visit.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: percentage of participants
93.7 93.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TAF, FTC/RPV/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 FTC/RPV/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 FTC/RPV/TDF group.
Type of Statistical Test Non-Inferiority
Comments A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/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.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.3
Confidence Interval (2-Sided) 95.001%
-4.2 to 3.7
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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TAF, FTC/RPV/TDF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
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 The percentage of participants with 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
Participants in the Full Analysis Set were analyzed.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: percentage of participants
0.6 0
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 The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: percentage of participants
0.6 1.0
4.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 The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: percentage of participants
89.2 88.5
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 FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 296 293
Mean (Standard Deviation)
Unit of Measure: cells/µL
9  (159.7) -1  (152.7)
6.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 FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 283 277
Mean (Standard Deviation)
Unit of Measure: cells/µL
12  (180.6) 16  (171.9)
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; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set (all randomized participants who 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 FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 168 165
Mean (Standard Deviation)
Unit of Measure: percentage change
1.040  (1.9404) -0.245  (2.0805)
8.Secondary Outcome
Title Percent 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 FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 160 156
Mean (Standard Deviation)
Unit of Measure: percentage change
1.623  (2.4575) -0.613  (2.7411)
9.Secondary Outcome
Title Percent 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 (all randomized participants who 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 FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 172 168
Mean (Standard Deviation)
Unit of Measure: percentage change
1.613  (3.4346) 0.075  (2.9605)
10.Secondary Outcome
Title Percent 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 FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 162 158
Mean (Standard Deviation)
Unit of Measure: percentage change
2.039  (3.5098) -0.250  (3.5903)
Time Frame First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
Hide Arm/Group Description Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus FTC/RPV/TDF placebo tablet administered orally once daily. Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TDF group, who received FTC/RPV/TDF (200/25/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
All-Cause Mortality
FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/316 (0.32%)   2/314 (0.64%)   0/19 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/316 (11.39%)   29/314 (9.24%)   1/19 (5.26%)   0/17 (0.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Angina pectoris  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Angina unstable  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Coronary artery disease  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Myocardial infarction  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Colitis  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Gastric ulcer perforation  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Inguinal hernia  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
General disorders         
Chest pain  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Generalised oedema  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Non-cardiac chest pain  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Cholecystitis acute  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Cholelithiasis  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Immune system disorders         
Hypersensitivity  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Infections and infestations         
Abscess limb  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Anal chlamydia infection  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Appendicitis  1  1/316 (0.32%)  4/314 (1.27%)  0/19 (0.00%)  0/17 (0.00%) 
Bronchitis  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Cellulitis  1  3/316 (0.95%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Cellulitis staphylococcal  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Diverticulitis  1  0/316 (0.00%)  2/314 (0.64%)  0/19 (0.00%)  0/17 (0.00%) 
Gastroenteritis  1  0/316 (0.00%)  0/314 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Gastroenteritis cryptosporidial  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Helicobacter infection  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Hepatitis A  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Myelitis  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Osteomyelitis  1  2/316 (0.63%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Osteomyelitis acute  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Pharyngitis  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Pneumonia  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Proctitis gonococcal  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Sepsis  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Subcutaneous abscess  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Syphilis  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Tooth abscess  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications         
Carbon monoxide poisoning  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Hyphaema  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Meniscus injury  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Overdose  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Procedural pain  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Radius fracture  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Toxicity to various agents  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Muscular weakness  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Osteoarthritis  1  2/316 (0.63%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Rhabdomyolysis  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Chronic myeloid leukaemia  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Renal neoplasm  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Nervous system disorders         
Carotid artery aneurysm  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Cerebrovascular accident  1  2/316 (0.63%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Cervicobrachial syndrome  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Paraplegia  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Psychiatric disorders         
Completed suicide  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Depression  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Depression suicidal  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Major depression  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Suicidal ideation  1  2/316 (0.63%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Suicide attempt  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Calculus urethral  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Nephrolithiasis  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Renal colic  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Reproductive system and breast disorders         
Priapism  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/316 (0.00%)  2/314 (0.64%)  0/19 (0.00%)  0/17 (0.00%) 
Chronic obstructive pulmonary disease  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Nasal polyps  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Pulmonary embolism  1  3/316 (0.95%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Pulmonary granuloma  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Respiratory failure  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Social circumstances         
Substance use  1  1/316 (0.32%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  2/316 (0.63%)  0/314 (0.00%)  0/19 (0.00%)  0/17 (0.00%) 
Peripheral artery occlusion  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   249/316 (78.80%)   234/314 (74.52%)   14/19 (73.68%)   11/17 (64.71%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  5/316 (1.58%)  3/314 (0.96%)  1/19 (5.26%)  0/17 (0.00%) 
Endocrine disorders         
Hypothyroidism  1  1/316 (0.32%)  1/314 (0.32%)  1/19 (5.26%)  0/17 (0.00%) 
Eye disorders         
Blepharitis  1  0/316 (0.00%)  1/314 (0.32%)  1/19 (5.26%)  0/17 (0.00%) 
Conjunctivitis allergic  1  0/316 (0.00%)  0/314 (0.00%)  2/19 (10.53%)  0/17 (0.00%) 
Eye pain  1  0/316 (0.00%)  1/314 (0.32%)  0/19 (0.00%)  1/17 (5.88%) 
Meibomianitis  1  0/316 (0.00%)  0/314 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Retinal detachment  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders         
Abdominal pain upper  1  6/316 (1.90%)  6/314 (1.91%)  1/19 (5.26%)  0/17 (0.00%) 
Diarrhoea  1  34/316 (10.76%)  40/314 (12.74%)  1/19 (5.26%)  2/17 (11.76%) 
Flatulence  1  5/316 (1.58%)  8/314 (2.55%)  0/19 (0.00%)  1/17 (5.88%) 
Inguinal hernia  1  2/316 (0.63%)  0/314 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Nausea  1  20/316 (6.33%)  11/314 (3.50%)  0/19 (0.00%)  0/17 (0.00%) 
Vomiting  1  17/316 (5.38%)  10/314 (3.18%)  0/19 (0.00%)  0/17 (0.00%) 
General disorders         
Fatigue  1  17/316 (5.38%)  28/314 (8.92%)  0/19 (0.00%)  0/17 (0.00%) 
Influenza like illness  1  2/316 (0.63%)  3/314 (0.96%)  1/19 (5.26%)  0/17 (0.00%) 
Pyrexia  1  7/316 (2.22%)  13/314 (4.14%)  0/19 (0.00%)  3/17 (17.65%) 
Immune system disorders         
Seasonal allergy  1  7/316 (2.22%)  5/314 (1.59%)  1/19 (5.26%)  0/17 (0.00%) 
Infections and infestations         
Anal chlamydia infection  1  3/316 (0.95%)  9/314 (2.87%)  1/19 (5.26%)  0/17 (0.00%) 
Bronchitis  1  22/316 (6.96%)  23/314 (7.32%)  1/19 (5.26%)  0/17 (0.00%) 
Chlamydial infection  1  10/316 (3.16%)  8/314 (2.55%)  1/19 (5.26%)  0/17 (0.00%) 
Fungal skin infection  1  3/316 (0.95%)  4/314 (1.27%)  1/19 (5.26%)  0/17 (0.00%) 
Gastroenteritis  1  10/316 (3.16%)  11/314 (3.50%)  1/19 (5.26%)  0/17 (0.00%) 
Genital herpes  1  3/316 (0.95%)  5/314 (1.59%)  1/19 (5.26%)  0/17 (0.00%) 
Influenza  1  19/316 (6.01%)  18/314 (5.73%)  0/19 (0.00%)  0/17 (0.00%) 
Nasopharyngitis  1  49/316 (15.51%)  46/314 (14.65%)  0/19 (0.00%)  3/17 (17.65%) 
Onychomycosis  1  4/316 (1.27%)  6/314 (1.91%)  1/19 (5.26%)  0/17 (0.00%) 
Oral herpes  1  6/316 (1.90%)  3/314 (0.96%)  2/19 (10.53%)  0/17 (0.00%) 
Papilloma viral infection  1  2/316 (0.63%)  2/314 (0.64%)  1/19 (5.26%)  0/17 (0.00%) 
Pharyngitis  1  14/316 (4.43%)  13/314 (4.14%)  1/19 (5.26%)  0/17 (0.00%) 
Pneumonia  1  1/316 (0.32%)  6/314 (1.91%)  1/19 (5.26%)  0/17 (0.00%) 
Respiratory tract infection  1  3/316 (0.95%)  2/314 (0.64%)  0/19 (0.00%)  1/17 (5.88%) 
Rhinitis  1  5/316 (1.58%)  2/314 (0.64%)  0/19 (0.00%)  1/17 (5.88%) 
Sinusitis  1  20/316 (6.33%)  23/314 (7.32%)  0/19 (0.00%)  0/17 (0.00%) 
Syphilis  1  16/316 (5.06%)  23/314 (7.32%)  0/19 (0.00%)  0/17 (0.00%) 
Tooth infection  1  5/316 (1.58%)  6/314 (1.91%)  1/19 (5.26%)  1/17 (5.88%) 
Upper respiratory tract infection  1  47/316 (14.87%)  46/314 (14.65%)  1/19 (5.26%)  1/17 (5.88%) 
Injury, poisoning and procedural complications         
Contusion  1  10/316 (3.16%)  5/314 (1.59%)  1/19 (5.26%)  0/17 (0.00%) 
Post-traumatic pain  1  1/316 (0.32%)  3/314 (0.96%)  0/19 (0.00%)  1/17 (5.88%) 
Investigations         
Weight decreased  1  3/316 (0.95%)  3/314 (0.96%)  1/19 (5.26%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  24/316 (7.59%)  32/314 (10.19%)  0/19 (0.00%)  1/17 (5.88%) 
Back pain  1  28/316 (8.86%)  34/314 (10.83%)  2/19 (10.53%)  1/17 (5.88%) 
Intervertebral disc protrusion  1  4/316 (1.27%)  4/314 (1.27%)  0/19 (0.00%)  1/17 (5.88%) 
Muscle contracture  1  1/316 (0.32%)  1/314 (0.32%)  0/19 (0.00%)  1/17 (5.88%) 
Myalgia  1  10/316 (3.16%)  9/314 (2.87%)  0/19 (0.00%)  2/17 (11.76%) 
Osteoarthritis  1  11/316 (3.48%)  4/314 (1.27%)  1/19 (5.26%)  0/17 (0.00%) 
Pain in extremity  1  25/316 (7.91%)  16/314 (5.10%)  1/19 (5.26%)  0/17 (0.00%) 
Rhabdomyolysis  1  0/316 (0.00%)  0/314 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lipoma  1  2/316 (0.63%)  0/314 (0.00%)  2/19 (10.53%)  0/17 (0.00%) 
Nervous system disorders         
Dizziness  1  11/316 (3.48%)  11/314 (3.50%)  0/19 (0.00%)  1/17 (5.88%) 
Facial paralysis  1  0/316 (0.00%)  3/314 (0.96%)  0/19 (0.00%)  1/17 (5.88%) 
Headache  1  25/316 (7.91%)  24/314 (7.64%)  0/19 (0.00%)  2/17 (11.76%) 
Paraesthesia  1  8/316 (2.53%)  7/314 (2.23%)  1/19 (5.26%)  0/17 (0.00%) 
Sciatica  1  4/316 (1.27%)  1/314 (0.32%)  1/19 (5.26%)  0/17 (0.00%) 
Syncope  1  2/316 (0.63%)  2/314 (0.64%)  1/19 (5.26%)  0/17 (0.00%) 
Psychiatric disorders         
Anxiety  1  17/316 (5.38%)  13/314 (4.14%)  0/19 (0.00%)  1/17 (5.88%) 
Depressed mood  1  1/316 (0.32%)  2/314 (0.64%)  0/19 (0.00%)  1/17 (5.88%) 
Depression  1  20/316 (6.33%)  13/314 (4.14%)  0/19 (0.00%)  0/17 (0.00%) 
Insomnia  1  11/316 (3.48%)  18/314 (5.73%)  0/19 (0.00%)  1/17 (5.88%) 
Sleep sex  1  0/316 (0.00%)  0/314 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders         
Dysuria  1  5/316 (1.58%)  5/314 (1.59%)  1/19 (5.26%)  0/17 (0.00%) 
Reproductive system and breast disorders         
Erectile dysfunction  1  9/316 (2.85%)  1/314 (0.32%)  0/19 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  6/316 (1.90%)  4/314 (1.27%)  1/19 (5.26%)  1/17 (5.88%) 
Cough  1  22/316 (6.96%)  24/314 (7.64%)  2/19 (10.53%)  3/17 (17.65%) 
Haemoptysis  1  0/316 (0.00%)  0/314 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
Rhinitis allergic  1  8/316 (2.53%)  3/314 (0.96%)  1/19 (5.26%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  6/316 (1.90%)  4/314 (1.27%)  1/19 (5.26%)  0/17 (0.00%) 
Pruritus  1  5/316 (1.58%)  2/314 (0.64%)  1/19 (5.26%)  0/17 (0.00%) 
Rash papular  1  1/316 (0.32%)  2/314 (0.64%)  1/19 (5.26%)  0/17 (0.00%) 
Skin fissures  1  1/316 (0.32%)  0/314 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Vascular disorders         
Hypertension  1  22/316 (6.96%)  9/314 (2.87%)  0/19 (0.00%)  0/17 (0.00%) 
Varicose vein  1  2/316 (0.63%)  0/314 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
1
Term from vocabulary, MedDRA 19.0
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
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections,Boston. March 4-7, 2018, Abstract 504.
Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation atthe 16th European AIDS Conference, 2017 25-27 October Milan, Italy.
Porter DP, Kulkarni R, Cao H, SenGupta D, White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster1381]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.
Wohl D, Kulkarni R, Garner W, White KL, Porter DL. Viral Blips Were Infrequent in HIV1-Infected Virologically-Suppressed Adults Treated with Tenofovir Alafenamide or Tenofovir DF Rilpivirine-Containing Regimens [Poster1384]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.
DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Molina J-M, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshopon HIV and Aging 2017 2-3 October, New York, New York.
Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, Thalme A, et al. Efficacy and Odefsey® StudyGS-US-366-1216Final Synoptic Clinical Study Report Final CONFIDENTIAL Page4 30July2019 Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.
Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science;2017 23-26July Paris, France.
Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, WA.
Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching toRPV/FTC/TAF in Women [Abstract12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.
Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study1160) or RPV/FTC/TDF (Study1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02345252    
Other Study ID Numbers: GS-US-366-1216
2014-004545-27 ( EudraCT Number )
First Submitted: January 19, 2015
First Posted: January 26, 2015
Results First Submitted: September 20, 2017
Results First Posted: December 8, 2017
Last Update Posted: January 2, 2020