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Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

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ClinicalTrials.gov Identifier: NCT01252940
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : April 19, 2013
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: FTC/RPV/TDF
Drug: PI
Drug: RTV
Drug: NRTIs
Enrollment 482
Recruitment Details Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.
Pre-assignment Details 617 participants were screened.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study. Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Period Title: Main Study Phase
Started 321 161
Completed 24 Weeks 0 153 [1]
Completed 295 149 [2]
Not Completed 26 12
Reason Not Completed
Randomized but not treated             4             2
Adverse Event             3             1
Lack of Efficacy             1             0
Lost to Follow-up             6             1
Physician Decision             1             0
Protocol Violation             4             2
Withdrawal by Subject             6             5
Subject Non-compliance             1             1
[1]
152 participants switched regimens at Week 24.
[2]
Discontinuations after switch: withdrawal by subject, 2; adverse event, 1; protocol violation, 1.
Period Title: Extension Phase
Started 110 [1] 49 [2]
Completed 100 46
Not Completed 10 3
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             1             0
Lost to Follow-up             5             0
Physician Decision             0             1
Subject Non-compliance             1             0
Withdrawal by Subject             1             1
[1]
FTC/RPV/TDF group: 110 participants completing the main study continued in extension phase.
[2]
SBR/Delayed Switch Group: 49 participants completing the main study continued in extension phase.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch Total
Hide Arm/Group Description Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study. Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit. Total of all reporting groups
Overall Number of Baseline Participants 317 159 476
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 317 participants 159 participants 476 participants
41  (9.2) 43  (9.7) 42  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 159 participants 476 participants
Female
44
  13.9%
15
   9.4%
59
  12.4%
Male
273
  86.1%
144
  90.6%
417
  87.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 159 participants 476 participants
Hispanic or Latino
51
  16.1%
31
  19.5%
82
  17.2%
Not Hispanic or Latino
264
  83.3%
128
  80.5%
392
  82.4%
Unknown or Not Reported
2
   0.6%
0
   0.0%
2
   0.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 317 participants 159 participants 476 participants
White 241 124 365
Black or African American 61 22 83
American Indian or Alaska Native 3 2 5
Asian 6 2 8
Other 6 9 15
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 317 participants 159 participants 476 participants
Austria 18 8 26
Belgium 15 13 28
Canada 15 10 25
France 29 14 43
Germany 31 12 43
Italy 16 10 26
Puerto Rico 16 2 18
Spain 15 5 20
United Kingdom 17 6 23
United States 149 81 230
[1]
Measure Description: Four participants in the Switch to FTC/RPV/TDF group and 2 participants in the Stay on Baseline Regimen (SBR) group were randomized but were not treated. These subjects are included in the analysis of the baseline characteristic "Region of Enrollment" but are not included in the analysis of other baseline characteristics.
Baseline HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 317 participants 159 participants 476 participants
< 50 Copies/mL 299 152 451
50 to < 200 Copies/mL 10 6 16
200 to < 400 Copies/mL 2 0 2
400 to < 1000 Copies/mL 2 0 2
≥ 1000 Copies/mL 4 1 5
Stratification based on antiretroviral (ARV) use  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 317 participants 159 participants 476 participants
TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV) 82 49 131
TDF or FTC/TDF + Other PI+RTV 178 81 259
Non-TDF-containing regimen + LPV/RTV 15 9 24
Non-TDF-containing regimen + Other PI+RTV 42 20 62
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 317 159
Measure Type: Number
Unit of Measure: percentage of participants
93.7 89.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-1.6 to 9.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
Hide Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 317 152
Measure Type: Number
Unit of Measure: percentage of participants
89.3 92.1
3.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24
Hide Description The mean (SD) change in CD4 count was analyzed from baseline through Week 24.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 298 148
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
20  (149.3) 32  (158.1)
4.Secondary Outcome
Title Change From Baseline in CD4 Count Through Week 48
Hide Description

The mean (SD) change in CD4 count was analyzed from baseline through Week 48.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 287 143
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
10  (144.1) -7  (154.1)
5.Secondary Outcome
Title Change From Baseline in Fasting Total Cholesterol Through Week 24
Hide Description The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 269 134
Mean (Standard Deviation)
Unit of Measure: mg/dL
-25  (30.2) -1  (25.9)
6.Secondary Outcome
Title Change From Baseline in Fasting Total Cholesterol Through Week 48
Hide Description

The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 265 139
Mean (Standard Deviation)
Unit of Measure: mg/dL
-24  (32.9) -24  (32.0)
7.Secondary Outcome
Title Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24
Hide Description The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 269 134
Mean (Standard Deviation)
Unit of Measure: mg/dL
-4  (10.3) -1  (8.2)
8.Secondary Outcome
Title Change From Baseline in Fasting HDL Cholesterol Through Week 48
Hide Description

The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 265 139
Mean (Standard Deviation)
Unit of Measure: mg/dL
-2  (11.6) -2  (8.0)
9.Secondary Outcome
Title Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24
Hide Description The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 270 134
Mean (Standard Deviation)
Unit of Measure: mg/dL
-16  (25.6) 0  (23.7)
10.Secondary Outcome
Title Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
Hide Description

The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 265 139
Mean (Standard Deviation)
Unit of Measure: mg/dL
-16  (27.1) -14  (26.8)
11.Secondary Outcome
Title Change From Baseline in Fasting Triglycerides Through Week 24
Hide Description The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 269 134
Mean (Standard Deviation)
Unit of Measure: mg/dL
-53  (110.0) 3  (100.1)
12.Secondary Outcome
Title Change From Baseline in Fasting Triglycerides Through Week 48
Hide Description

The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.

By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch
Hide Arm/Group Description:
Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Overall Number of Participants Analyzed 265 139
Mean (Standard Deviation)
Unit of Measure: mg/dL
-64  (126.4) -80  (141.1)
Time Frame Baseline through end of study (average 54 weeks)
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug
 
Arm/Group Title FTC/RPV/TDF SBR/Delayed Switch (up to Week 24) SBR/Delayed Switch (After Week 24)
Hide Arm/Group Description The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study. The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit. The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
All-Cause Mortality
FTC/RPV/TDF SBR/Delayed Switch (up to Week 24) SBR/Delayed Switch (After Week 24)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
FTC/RPV/TDF SBR/Delayed Switch (up to Week 24) SBR/Delayed Switch (After Week 24)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/317 (6.62%)   8/159 (5.03%)   9/152 (5.92%) 
Cardiac disorders       
Angina unstable † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Myocardial infarction † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Palpitations † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Eye disorders       
Visual acuity reduced † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Pancreatitis † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
General disorders       
Chest pain † 1  1/317 (0.32%)  0/159 (0.00%)  1/152 (0.66%) 
Pyrexia † 1  1/317 (0.32%)  1/159 (0.63%)  0/152 (0.00%) 
Hepatobiliary disorders       
Cholecystitis † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Infections and infestations       
Acute sinusitis † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Anal abscess † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Cellulitis † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Diverticulitis † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Lung infection † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Parainfluenzae virus infection † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Pneumonia † 1  3/317 (0.95%)  0/159 (0.00%)  0/152 (0.00%) 
Pneumonia bacterial † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Shigella infection † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Subcutaneous abscess † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Urosepsis † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Viral infection † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Viral upper respiratory tract infection † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Meniscus injury † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Procedural pain † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Stab wound † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Investigations       
Blood creatine phosphokinase increased † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Arthritis reactive † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Bursitis † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Muscular weakness † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Musculoskeletal chest pain † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Polyarthritis † 1  0/317 (0.00%)  1/159 (0.63%)  0/152 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign neoplasm of thyroid gland † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Nervous system disorders       
Hypoaesthesia † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Neuropathy peripheral † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Sensory loss † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Psychiatric disorders       
Bipolar disorder † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Substance-induced mood disorder † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Suicidal ideation † 1  1/317 (0.32%)  0/159 (0.00%)  1/152 (0.66%) 
Renal and urinary disorders       
Nephropathy toxic † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Renal impairment † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Reproductive system and breast disorders       
Prostatism † 1  0/317 (0.00%)  0/159 (0.00%)  1/152 (0.66%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Asthma † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Dyspnoea † 1  1/317 (0.32%)  0/159 (0.00%)  1/152 (0.66%) 
Sleep apnoea syndrome † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
Vascular disorders       
Arterial occlusive disease † 1  1/317 (0.32%)  0/159 (0.00%)  0/152 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TDF SBR/Delayed Switch (up to Week 24) SBR/Delayed Switch (After Week 24)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   150/317 (47.32%)   38/159 (23.90%)   59/152 (38.82%) 
Gastrointestinal disorders       
Diarrhoea † 1  34/317 (10.73%)  8/159 (5.03%)  6/152 (3.95%) 
Nausea † 1  13/317 (4.10%)  5/159 (3.14%)  10/152 (6.58%) 
General disorders       
Fatigue † 1  22/317 (6.94%)  5/159 (3.14%)  4/152 (2.63%) 
Infections and infestations       
Nasopharyngitis † 1  35/317 (11.04%)  8/159 (5.03%)  12/152 (7.89%) 
Upper respiratory tract infection † 1  15/317 (4.73%)  5/159 (3.14%)  13/152 (8.55%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  18/317 (5.68%)  2/159 (1.26%)  3/152 (1.97%) 
Back pain † 1  13/317 (4.10%)  6/159 (3.77%)  8/152 (5.26%) 
Nervous system disorders       
Headache † 1  31/317 (9.78%)  6/159 (3.77%)  6/152 (3.95%) 
Psychiatric disorders       
Depression † 1  18/317 (5.68%)  4/159 (2.52%)  6/152 (3.95%) 
Insomnia † 1  21/317 (6.62%)  3/159 (1.89%)  9/152 (5.92%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  23/317 (7.26%)  1/159 (0.63%)  2/152 (1.32%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[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
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Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01252940    
Other Study ID Numbers: GS-US-264-0106
2010-023178-37 ( EudraCT Number )
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: March 8, 2013
Results First Posted: April 19, 2013
Last Update Posted: December 4, 2015