Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02345226
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : October 19, 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: EFV/FTC/TDF Placebo
Drug: EFV/FTC/TDF
Drug: FTC/RPV/TAF Placebo
Enrollment 881
Recruitment Details Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 02 January 2019.
Pre-assignment Details 974 participants were screened.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description

Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/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 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.

Double-Blind Phase: EFV/FTC/TDF (600/200/300 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 440 441
Completed 371 370
Not Completed 69 71
Reason Not Completed
Adverse Event             5             6
Death             3             0
Pregnancy             0             1
Lack of Efficacy             1             0
Investigator's Discretion             4             3
Non-Compliance with Study Drug             1             2
Withdrew Consent             41             39
Lost to Follow-up             12             16
Randomized but Never Treated             2             4
Period Title: Open-Label Extension Phase
Started 25 [1] 21 [2]
Completed 25 20
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
[1]
346 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
[2]
349 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF Total
Hide Arm/Group Description FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks. EFV/FTC/TDF (600/200/300 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 438 437 875
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 438 participants 437 participants 875 participants
48  (9.8) 47  (10.5) 48  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
Female 373 390 763
Male 65 47 112
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
American Indian or Alaska Native 3 2 5
Asian 9 8 17
Black 118 120 238
Native Hawaiian or Pacific Islander 1 0 1
White 291 292 583
Not Permitted 6 3 9
Other 10 12 22
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
Hispanic or Latino 79 78 157
Not Hispanic or Latino 358 359 717
Not Permitted 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 438 participants 437 participants 875 participants
Canada 20 24 44
Belgium 3 4 7
United States 351 345 696
United Kingdom 4 11 15
France 7 6 13
Switzerland 6 5 11
Germany 33 27 60
Spain 14 15 29
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
< 50 copies/mL 430 432 862
≥ 50 copies/mL 8 5 13
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 438 participants 437 participants 875 participants
711  (292.3) 688  (263.5) 700  (278.4)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 437 participants 875 participants
≥ 50 to < 200 cells/µL 2 5 7
≥ 200 to < 350 cells/µL 41 26 67
≥ 350 to < 500 cells/µL 63 74 137
≥ 500 cells/ µL 332 332 664
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on EFV/FTC/TDF prior to the screening visit.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
90.0 92.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TAF, EFV/FTC/TDF
Comments The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.
Type of Statistical Test Non-Inferiority
Comments A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.0
Confidence Interval (2-Sided) 95.001%
-5.9 to 1.8
Estimation Comments The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TAF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0.9
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm
Hide Description 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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
0.7 0.9
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
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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 438 437
Measure Type: Number
Unit of Measure: percentage of participants
85.2 85.1
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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 390 403
Mean (Standard Deviation)
Unit of Measure: cells/µL
23  (156.4) 12  (153.3)
6.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; 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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 370 371
Mean (Standard Deviation)
Unit of Measure: cells/µL
12  (199.8) 6  (153.2)
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 received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 347 367
Mean (Standard Deviation)
Unit of Measure: percentage change
1.279  (2.3800) -0.134  (2.4930)
8.Secondary Outcome
Title Percent Change From Baseline in Hip 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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 322 345
Mean (Standard Deviation)
Unit of Measure: percentage change
1.831  (3.2925) -0.617  (3.3046)
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, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 351 369
Mean (Standard Deviation)
Unit of Measure: percentage change
1.645  (3.3198) -0.045  (2.9087)
10.Secondary Outcome
Title Percent Change From Baseline in Spine 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 EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 327 344
Mean (Standard Deviation)
Unit of Measure: percentage change
1.701  (3.6185) 0.126  (3.2400)
11.Secondary Outcome
Title Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48
Hide Description The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 368 383
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (3.4) -1  (3.4)
12.Secondary Outcome
Title Change From Baseline in HIVSI Score at Week 96
Hide Description The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title FTC/RPV/TAF EFV/FTC/TDF
Hide Arm/Group Description:
FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.
EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Overall Number of Participants Analyzed 347 347
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (4.1) -1  (3.3)
Time Frame First dose date to last dose date (maximum duration: 172.4 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) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/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 EFV/FTC/TDF placebo tablet administered orally once daily. Adverse events reported occurred during the Double-Blind Phase in participants from the EFV/FTC/TDF group, who received EFV/FTC/TDF (600/200/300 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 EFV/FTC/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
All-Cause Mortality
FTC/RPV/TAF (Double-Blind Phase) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/438 (0.68%)   0/437 (0.00%)   0/25 (0.00%)   0/21 (0.00%) 
Hide Serious Adverse Events
FTC/RPV/TAF (Double-Blind Phase) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/438 (12.33%)   45/437 (10.30%)   0/25 (0.00%)   1/21 (4.76%) 
Blood and lymphatic system disorders         
Haemorrhagic anaemia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Cardiac disorders         
Acute myocardial infarction † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Angina pectoris † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Atrial fibrillation † 1  1/438 (0.23%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Coronary artery disease † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Myocardial infarction † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Pericarditis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Sinus tachycardia † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Supraventricular tachycardia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  2/438 (0.46%)  3/437 (0.69%)  0/25 (0.00%)  0/21 (0.00%) 
Anal stenosis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Colitis † 1  1/438 (0.23%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Diarrhoea † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Incarcerated inguinal hernia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Large intestine perforation † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Nausea † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Oesophageal ulcer † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Rectal perforation † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Vomiting † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
General disorders         
Asthenia † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Chest pain † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Pyrexia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Hepatobiliary disorders         
Cholecystitis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Cholelithiasis † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Infections and infestations         
Abdominal abscess † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Abscess † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Appendicitis † 1  0/438 (0.00%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Bacterial parotitis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Bronchitis † 1  0/438 (0.00%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Cellulitis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Cellulitis orbital † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Cellulitis staphylococcal † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Diarrhoea infectious † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  1/21 (4.76%) 
Diverticulitis † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Escherichia bacteraemia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Gastroenteritis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Gastroenteritis salmonella † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Gastroenteritis shigella † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Gastrointestinal infection † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Infectious colitis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Localised infection † 1  1/438 (0.23%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Necrotising fasciitis † 1  3/438 (0.68%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Orchitis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Osteomyelitis † 1  0/438 (0.00%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Perineal abscess † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Pneumonia † 1  5/438 (1.14%)  3/437 (0.69%)  0/25 (0.00%)  0/21 (0.00%) 
Scrotal infection † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Sepsis † 1  2/438 (0.46%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Stoma site abscess † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Urinary tract infection † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications         
Animal bite † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Clavicle fracture † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Fibula fracture † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Foot fracture † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Limb fracture † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Limb injury † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Multiple fractures † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Overdose † 1  1/438 (0.23%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Post procedural complication † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Road traffic accident † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Tibia fracture † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Investigations         
Blood creatine phosphokinase increased † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Hypercalcaemia † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Metabolic acidosis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Osteoarthritis † 1  1/438 (0.23%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Pathological fracture † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenosquamous cell lung cancer † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Bronchial carcinoma † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Laryngeal papilloma † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Laryngeal squamous cell carcinoma † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Lymphoma † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Metastases to bone † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Non-small cell lung cancer stage IV † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Prostate cancer † 1  2/438 (0.46%)  3/437 (0.69%)  0/25 (0.00%)  0/21 (0.00%) 
Squamous cell carcinoma of the tongue † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Aphasia † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Ataxia † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Carotid artery stenosis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Dizziness † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Syncope † 1  1/438 (0.23%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Transient ischaemic attack † 1  1/438 (0.23%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Psychiatric disorders         
Alcohol abuse † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Alcohol withdrawal syndrome † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Bipolar II disorder † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Delirium † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Drug abuse † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Mental status changes † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Suicidal ideation † 1  1/438 (0.23%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Suicide attempt † 1  1/438 (0.23%)  2/437 (0.46%)  0/25 (0.00%)  0/21 (0.00%) 
Renal and urinary disorders         
Acute kidney injury † 1  0/438 (0.00%)  3/437 (0.69%)  0/25 (0.00%)  0/21 (0.00%) 
Fanconi syndrome acquired † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Ureterolithiasis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Reproductive system and breast disorders         
Prostatitis † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  2/438 (0.46%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Chronic obstructive pulmonary disease † 1  1/438 (0.23%)  3/437 (0.69%)  0/25 (0.00%)  0/21 (0.00%) 
Dyspnoea † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Pleuritic pain † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Pulmonary embolism † 1  4/438 (0.91%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Pulmonary infarction † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Respiratory failure † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Surgical and medical procedures         
Ileostomy closure † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Knee arthroplasty † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Vascular disorders         
Aortic dissection † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Circulatory collapse † 1  0/438 (0.00%)  1/437 (0.23%)  0/25 (0.00%)  0/21 (0.00%) 
Deep vein thrombosis † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
Peripheral artery aneurysm † 1  1/438 (0.23%)  0/437 (0.00%)  0/25 (0.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
†
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) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   277/438 (63.24%)   270/437 (61.78%)   13/25 (52.00%)   9/21 (42.86%) 
Gastrointestinal disorders         
Abdominal pain † 1  22/438 (5.02%)  13/437 (2.97%)  0/25 (0.00%)  0/21 (0.00%) 
Diarrhoea † 1  41/438 (9.36%)  47/437 (10.76%)  1/25 (4.00%)  2/21 (9.52%) 
Nausea † 1  23/438 (5.25%)  16/437 (3.66%)  0/25 (0.00%)  0/21 (0.00%) 
Infections and infestations         
Bronchitis † 1  24/438 (5.48%)  28/437 (6.41%)  2/25 (8.00%)  0/21 (0.00%) 
Nasopharyngitis † 1  51/438 (11.64%)  39/437 (8.92%)  3/25 (12.00%)  1/21 (4.76%) 
Pharyngitis † 1  12/438 (2.74%)  19/437 (4.35%)  2/25 (8.00%)  1/21 (4.76%) 
Rhinitis † 1  5/438 (1.14%)  7/437 (1.60%)  4/25 (16.00%)  0/21 (0.00%) 
Sinusitis † 1  23/438 (5.25%)  32/437 (7.32%)  1/25 (4.00%)  0/21 (0.00%) 
Syphilis † 1  39/438 (8.90%)  31/437 (7.09%)  0/25 (0.00%)  2/21 (9.52%) 
Upper respiratory tract infection † 1  74/438 (16.89%)  70/437 (16.02%)  1/25 (4.00%)  1/21 (4.76%) 
Urinary tract infection † 1  22/438 (5.02%)  7/437 (1.60%)  0/25 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  34/438 (7.76%)  42/437 (9.61%)  0/25 (0.00%)  1/21 (4.76%) 
Back pain † 1  35/438 (7.99%)  37/437 (8.47%)  1/25 (4.00%)  0/21 (0.00%) 
Pain in extremity † 1  28/438 (6.39%)  15/437 (3.43%)  0/25 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Headache † 1  35/438 (7.99%)  31/437 (7.09%)  1/25 (4.00%)  0/21 (0.00%) 
Psychiatric disorders         
Insomnia † 1  26/438 (5.94%)  23/437 (5.26%)  0/25 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  45/438 (10.27%)  30/437 (6.86%)  2/25 (8.00%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders         
Eczema † 1  4/438 (0.91%)  2/437 (0.46%)  0/25 (0.00%)  2/21 (9.52%) 
Rash † 1  24/438 (5.48%)  16/437 (3.66%)  0/25 (0.00%)  0/21 (0.00%) 
Vascular disorders         
Hypertension † 1  25/438 (5.71%)  16/437 (3.66%)  1/25 (4.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
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:
Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.
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): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy.
Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California.
E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York.
Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and 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 26 July Paris, France.
DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2.
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 [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington.
Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 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. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02345226    
Other Study ID Numbers: GS-US-366-1160
2014-004779-21 ( EudraCT Number )
First Submitted: January 19, 2015
First Posted: January 26, 2015
Results First Submitted: September 21, 2017
Results First Posted: October 19, 2017
Last Update Posted: January 2, 2020