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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 30, 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/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 Week 48 study visit occurred on 22 June 2016.
Pre-assignment Details 690 participants were screened.
Arm/Group Title FTC/RPV/TAF FTC/RPV/TDF
Hide Arm/Group Description Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey® (ODE); FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera®(CPA)/Eviplera®; FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Period Title: Overall Study
Started 316 316
Completed 0 0
Not Completed 316 316
Reason Not Completed
Adverse Event             1             0
Death             1             1
Investigator's Discretion             0             1
Protocol Violation             1             0
Withdrew Consent             7             9
Lost to Follow-up             2             3
Randomized but Never Treated             0             2
Still in Study up to the Data Cut Date             304             300
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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 316 314 630
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 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
  13.0%
25
   8.0%
66
  10.5%
Male
275
  87.0%
289
  92.0%
564
  89.5%
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
   0.3%
2
   0.6%
3
   0.5%
Asian
7
   2.2%
17
   5.4%
24
   3.8%
Black
65
  20.6%
54
  17.2%
119
  18.9%
Native Hawaiian or Pacific Islander
0
   0.0%
1
   0.3%
1
   0.2%
White
238
  75.3%
235
  74.8%
473
  75.1%
Other
5
   1.6%
5
   1.6%
10
   1.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
Hispanic or Latino
40
  12.7%
53
  16.9%
93
  14.8%
Not Hispanic or Latino
275
  87.0%
261
  83.1%
536
  85.1%
Not Permitted
1
   0.3%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
Canada
24
   7.6%
11
   3.5%
35
   5.6%
Netherlands
3
   0.9%
4
   1.3%
7
   1.1%
Sweden
2
   0.6%
2
   0.6%
4
   0.6%
Belgium
5
   1.6%
4
   1.3%
9
   1.4%
United States
222
  70.3%
226
  72.0%
448
  71.1%
Italy
3
   0.9%
8
   2.5%
11
   1.7%
United Kingdom
10
   3.2%
9
   2.9%
19
   3.0%
France
1
   0.3%
1
   0.3%
2
   0.3%
Switzerland
4
   1.3%
4
   1.3%
8
   1.3%
Germany
27
   8.5%
30
   9.6%
57
   9.0%
Spain
15
   4.7%
15
   4.8%
30
   4.8%
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 314 participants 630 participants
< 50 copies/mL
307
  97.2%
312
  99.4%
619
  98.3%
≥ 50 copies/mL
9
   2.8%
2
   0.6%
11
   1.7%
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)
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
Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on FTC/RPV/TDF prior to 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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: percentage of participants
93.7 93.9
Show Statistical Analysis 1 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.
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
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.
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 [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on FTC/RPV/TDF prior to 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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 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 [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Hide Description [Not Specified]
Time Frame Week 96
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline and 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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
Overall Number of Participants Analyzed 296 293
Mean (Standard Deviation)
Unit of Measure: cells/uL
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 and Week 96
Outcome Measure Data Not Reported
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 and 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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 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 Bone Mineral Density (BMD) at Week 96
Hide Description Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Hide Description Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and 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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 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 Bone Mineral Density (BMD) at Week 96
Hide Description Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline and Week 96
Outcome Measure Data Not Reported
Time Frame Up to 48 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: all randomized participants who received at least one dose of study drug
 
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 in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks in the Randomized Phase, with the option to receive open-label FTC/RPV/TAF for up to an additional 48 weeks
All-Cause Mortality
FTC/RPV/TAF FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FTC/RPV/TAF FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   18/316 (5.70%)   12/314 (3.82%) 
Cardiac disorders     
Cardiac arrest  1  1/316 (0.32%)  0/314 (0.00%) 
Myocardial infarction  1  1/316 (0.32%)  0/314 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/316 (0.32%)  0/314 (0.00%) 
Colitis  1  0/316 (0.00%)  1/314 (0.32%) 
Gastric ulcer perforation  1  1/316 (0.32%)  0/314 (0.00%) 
General disorders     
Generalised oedema  1  1/316 (0.32%)  0/314 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  1/316 (0.32%)  0/314 (0.00%) 
Cholecystitis acute  1  1/316 (0.32%)  0/314 (0.00%) 
Cholelithiasis  1  1/316 (0.32%)  0/314 (0.00%) 
Immune system disorders     
Hypersensitivity  1  0/316 (0.00%)  1/314 (0.32%) 
Infections and infestations     
Bronchitis  1  0/316 (0.00%)  1/314 (0.32%) 
Cellulitis  1  1/316 (0.32%)  0/314 (0.00%) 
Cellulitis staphylococcal  1  1/316 (0.32%)  0/314 (0.00%) 
Gastroenteritis cryptosporidial  1  1/316 (0.32%)  0/314 (0.00%) 
Helicobacter infection  1  1/316 (0.32%)  0/314 (0.00%) 
Myelitis  1  1/316 (0.32%)  0/314 (0.00%) 
Osteomyelitis  1  2/316 (0.63%)  0/314 (0.00%) 
Pharyngitis  1  0/316 (0.00%)  1/314 (0.32%) 
Pneumonia  1  1/316 (0.32%)  1/314 (0.32%) 
Sepsis  1  1/316 (0.32%)  0/314 (0.00%) 
Tooth abscess  1  0/316 (0.00%)  1/314 (0.32%) 
Injury, poisoning and procedural complications     
Carbon monoxide poisoning  1  0/316 (0.00%)  1/314 (0.32%) 
Radius fracture  1  1/316 (0.32%)  0/314 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/316 (0.32%)  0/314 (0.00%) 
Muscular weakness  1  0/316 (0.00%)  1/314 (0.32%) 
Rhabdomyolysis  1  1/316 (0.32%)  0/314 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic myeloid leukaemia  1  0/316 (0.00%)  1/314 (0.32%) 
Nervous system disorders     
Carotid artery aneurysm  1  1/316 (0.32%)  0/314 (0.00%) 
Cerebrovascular accident  1  1/316 (0.32%)  0/314 (0.00%) 
Paraplegia  1  0/316 (0.00%)  1/314 (0.32%) 
Psychiatric disorders     
Depression  1  0/316 (0.00%)  1/314 (0.32%) 
Depression suicidal  1  1/316 (0.32%)  0/314 (0.00%) 
Drug abuse  1  1/316 (0.32%)  0/314 (0.00%) 
Suicidal ideation  1  1/316 (0.32%)  1/314 (0.32%) 
Renal and urinary disorders     
Acute kidney injury  1  1/316 (0.32%)  0/314 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/316 (0.00%)  2/314 (0.64%) 
Chronic obstructive pulmonary disease  1  0/316 (0.00%)  1/314 (0.32%) 
Nasal polyps  1  0/316 (0.00%)  1/314 (0.32%) 
Pulmonary embolism  1  2/316 (0.63%)  0/314 (0.00%) 
Pulmonary granuloma  1  0/316 (0.00%)  1/314 (0.32%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/316 (0.32%)  0/314 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TAF FTC/RPV/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   94/316 (29.75%)   100/314 (31.85%) 
Gastrointestinal disorders     
Diarrhoea  1  23/316 (7.28%)  26/314 (8.28%) 
Infections and infestations     
Bronchitis  1  12/316 (3.80%)  17/314 (5.41%) 
Nasopharyngitis  1  22/316 (6.96%)  24/314 (7.64%) 
Sinusitis  1  12/316 (3.80%)  18/314 (5.73%) 
Upper respiratory tract infection  1  27/316 (8.54%)  26/314 (8.28%) 
Nervous system disorders     
Headache  1  15/316 (4.75%)  17/314 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02345252     History of Changes
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 30, 2019