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Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01309243
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : November 27, 2013
Last Update Posted : February 25, 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: EFV/FTC/TDF
Enrollment 799

Recruitment Details Subjects were enrolled in a total of 121 study sites in North America, Europe, and Australia. The first participant was screened on 23 February 2011. The last participant observation was on 03 February 2014.
Pre-assignment Details 991 participants were screened.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Period Title: Randomized Phase Through Week 96
Started 400 399
Randomized and Treated 394 392
Completed 316 290
Not Completed 84 109
Reason Not Completed
Randomized but not treated             6             7
Adverse Event             12             43
Death             0             1
Pregnancy             2             0
Lack of Efficacy             16             4
Investigators Discretion             3             6
Withdrew Consent             12             18
Lost to Follow-up             23             22
Subject Non-Compliance             9             7
Protocol Violation             1             1
Period Title: Extension Phase
Started 40 [1] 117 [2]
Completed 34 117
Not Completed 6 0
Reason Not Completed
Lost to Follow-up             6             0
[1]
40 participants from the Randomized Phase continued the study in the Extension Phase.
[2]
117 participants from the Randomized Phase continued the study in the Extension Phase.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF Total
Hide Arm/Group Description FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily Total of all reporting groups
Overall Number of Baseline Participants 394 392 786
Hide Baseline Analysis Population Description
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 394 participants 392 participants 786 participants
37  (10.4) 37  (11.0) 37  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
Female
28
   7.1%
28
   7.1%
56
   7.1%
Male
366
  92.9%
364
  92.9%
730
  92.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
American Indian or Alaska Native 3 1 4
Asian 8 13 21
Black or African Heritage 98 94 192
Native Hawaiian or Pacific Islander 4 3 7
White 266 262 528
Other 13 19 32
Not Permitted 1 0 1
Not Reported 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
Hispanic/Latino 59 75 134
Non-Hispanic/Latino 331 315 646
Not Permitted 3 2 5
Not Reported 1 0 1
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
United States 262 279 541
Australia 15 25 40
Canada 28 20 48
Germany 25 22 47
France 16 7 23
United Kingdom 12 8 20
Puerto Rico 8 10 18
Spain 9 6 15
Italy 10 3 13
Belgium 4 5 9
Portugal 2 5 7
Switzerland 2 3 5
Austria 7 6 13
[1]
Measure Description: All randomized participants were analyzed for Region of Enrollment
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 394 participants 392 participants 786 participants
4.8  (0.65) 4.8  (0.61) 4.8  (0.63)
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
≤ 100,000 copies/mL 260 250 510
> 100,000 copies/mL 134 142 276
Cluster of differentiation 4 (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/μL
Number Analyzed 394 participants 392 participants 786 participants
395.7  (179.64) 385.2  (186.82) 390.5  (183.21)
Use of lipid-lowering agent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 394 participants 392 participants 786 participants
Yes 4 1 5
No 390 391 781
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description

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

The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 394 392
Measure Type: Number
Unit of Measure: percentage of participants
85.8 81.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments

The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI > -12%).

700 subjects allocated 1:1 to either treatment arm was predicted to give > 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48.

Type of Statistical Test Non-Inferiority or Equivalence
Comments

Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA < 50 copies/mL (“response rate,” as defined by the snapshot analysis algorithm) at Week 48.

Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA < 50 copies/mL at Week 48.

Method of Estimation Estimation Parameter Difference in the response rates
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-1.1 to 9.2
Estimation Comments The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and > 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 394 392
Measure Type: Number
Unit of Measure: percentage of participants
77.9 72.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the response rates
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
-0.6 to 11.5
Estimation Comments The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and > 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.
3.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 357 346
Mean (Standard Deviation)
Unit of Measure: cells/μL
200  (158.6) 191  (144.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 11
Confidence Interval (2-Sided) 95%
-11 to 32
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 327 319
Mean (Standard Deviation)
Unit of Measure: cells/μL
278  (186.6) 259  (191.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 20
Confidence Interval (2-Sided) 95%
-9 to 49
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Fasting Total Cholesterol at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 322 305
Mean (Standard Deviation)
Unit of Measure: mg/dL
1  (28.1) 22  (31.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 322 305
Mean (Standard Deviation)
Unit of Measure: mg/dL
2  (8.7) 8  (10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 322 303
Mean (Standard Deviation)
Unit of Measure: mg/dL
1  (24.4) 14  (28.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Fasting Triglycerides at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 322 305
Mean (Standard Deviation)
Unit of Measure: mg/dL
-8  (68.9) 8  (103.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/RPV/TDF, EFV/FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Development of HIV-1 Drug Resistance Through Week 96, All Participants
Hide Description Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 394 392
Measure Type: Number
Unit of Measure: percentage of participants
Baseline through Week 48 4.3 0.8
Week 48 through Week 96 1.0 0.3
Baseline through Week 96 5.3 1.0
10.Secondary Outcome
Title Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance
Hide Description Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Resistance Analysis Set
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description:
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Overall Number of Participants Analyzed 24 9
Measure Type: Number
Unit of Measure: participants
Baseline through Week 48 17 3
Week 48 through Week 96 4 1
Baseline through Week 96 21 4
Time Frame Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title FTC/RPV/TDF EFV/FTC/TDF
Hide Arm/Group Description FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
All-Cause Mortality
FTC/RPV/TDF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FTC/RPV/TDF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   36/394 (9.14%)   48/392 (12.24%) 
Blood and lymphatic system disorders     
Haemolytic anaemia  1  0/394 (0.00%)  1/392 (0.26%) 
Cardiac disorders     
Myocardial infarction  1  1/394 (0.25%)  1/392 (0.26%) 
Tachycardia  1  1/394 (0.25%)  0/392 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis  1  0/394 (0.00%)  1/392 (0.26%) 
Gastrointestinal disorders     
Rectal haemorrhage  1  0/394 (0.00%)  2/392 (0.51%) 
Abdominal pain  1  1/394 (0.25%)  0/392 (0.00%) 
Anal fistula  1  0/394 (0.00%)  1/392 (0.26%) 
Colitis  1  0/394 (0.00%)  1/392 (0.26%) 
Gastritis  1  0/394 (0.00%)  1/392 (0.26%) 
Gastrointestinal haemorrhage  1  1/394 (0.25%)  0/392 (0.00%) 
Inguinal hernia  1  1/394 (0.25%)  0/392 (0.00%) 
Large intestine perforation  1  1/394 (0.25%)  0/392 (0.00%) 
Vomiting  1  1/394 (0.25%)  0/392 (0.00%) 
General disorders     
Chest pain  1  2/394 (0.51%)  0/392 (0.00%) 
Pyrexia  1  0/394 (0.00%)  2/392 (0.51%) 
Non-cardiac chest pain  1  1/394 (0.25%)  0/392 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/394 (0.00%)  1/392 (0.26%) 
Cholelithiasis  1  0/394 (0.00%)  1/392 (0.26%) 
Liver injury  1  0/394 (0.00%)  1/392 (0.26%) 
Immune system disorders     
Anaphylactic reaction  1  1/394 (0.25%)  0/392 (0.00%) 
Hypersensitivity  1  0/394 (0.00%)  1/392 (0.26%) 
Infections and infestations     
Appendicitis  1  2/394 (0.51%)  0/392 (0.00%) 
Cellulitis  1  1/394 (0.25%)  1/392 (0.26%) 
Gastroenteritis  1  1/394 (0.25%)  1/392 (0.26%) 
Neurosyphilis  1  0/394 (0.00%)  2/392 (0.51%) 
Ophthalmic herpes zoster  1  1/394 (0.25%)  1/392 (0.26%) 
Abscess limb  1  0/394 (0.00%)  1/392 (0.26%) 
Anal abscess  1  0/394 (0.00%)  1/392 (0.26%) 
Arthritis bacterial  1  0/394 (0.00%)  1/392 (0.26%) 
Atypical pneumonia  1  0/394 (0.00%)  1/392 (0.26%) 
Bronchitis  1  0/394 (0.00%)  1/392 (0.26%) 
Eye infection syphilitic  1  0/394 (0.00%)  1/392 (0.26%) 
Furuncle  1  1/394 (0.25%)  0/392 (0.00%) 
Gastroenteritis shigella  1  0/394 (0.00%)  1/392 (0.26%) 
Meningitis aseptic  1  0/394 (0.00%)  1/392 (0.26%) 
Meningitis viral  1  1/394 (0.25%)  0/392 (0.00%) 
Rectal abscess  1  0/394 (0.00%)  1/392 (0.26%) 
Secondary syphilis  1  0/394 (0.00%)  1/392 (0.26%) 
Sepsis  1  1/394 (0.25%)  0/392 (0.00%) 
Septic shock  1  0/394 (0.00%)  1/392 (0.26%) 
Staphylococcal bacteraemia  1  0/394 (0.00%)  1/392 (0.26%) 
Staphylococcal infection  1  1/394 (0.25%)  0/392 (0.00%) 
Injury, poisoning and procedural complications     
Concussion  1  2/394 (0.51%)  0/392 (0.00%) 
Ankle fracture  1  0/394 (0.00%)  1/392 (0.26%) 
Clavicle fracture  1  1/394 (0.25%)  0/392 (0.00%) 
Fall  1  0/394 (0.00%)  1/392 (0.26%) 
Femoral neck fracture  1  0/394 (0.00%)  1/392 (0.26%) 
Limb injury  1  1/394 (0.25%)  0/392 (0.00%) 
Patella fracture  1  0/394 (0.00%)  1/392 (0.26%) 
Radius fracture  1  1/394 (0.25%)  0/392 (0.00%) 
Tendon rupture  1  1/394 (0.25%)  0/392 (0.00%) 
Upper limb fracture  1  1/394 (0.25%)  0/392 (0.00%) 
Wrist fracture  1  0/394 (0.00%)  1/392 (0.26%) 
Investigations     
Hepatic enzyme increased  1  0/394 (0.00%)  1/392 (0.26%) 
Metabolism and nutrition disorders     
Dehydration  1  0/394 (0.00%)  1/392 (0.26%) 
Musculoskeletal and connective tissue disorders     
Arthritis reactive  1  1/394 (0.25%)  0/392 (0.00%) 
Back pain  1  0/394 (0.00%)  1/392 (0.26%) 
Intervertebral disc protrusion  1  0/394 (0.00%)  1/392 (0.26%) 
Musculoskeletal chest pain  1  0/394 (0.00%)  1/392 (0.26%) 
Tenosynovitis  1  1/394 (0.25%)  0/392 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Burkitt’s lymphoma  1  1/394 (0.25%)  1/392 (0.26%) 
Anal squamous cell carcinoma  1  0/394 (0.00%)  1/392 (0.26%) 
Anogenital warts  1  0/394 (0.00%)  1/392 (0.26%) 
Craniopharyngioma  1  0/394 (0.00%)  1/392 (0.26%) 
Gliosarcoma  1  1/394 (0.25%)  0/392 (0.00%) 
Prostate cancer  1  1/394 (0.25%)  0/392 (0.00%) 
Rectal cancer stage 0  1  0/394 (0.00%)  1/392 (0.26%) 
Testicular germ cell cancer  1  0/394 (0.00%)  1/392 (0.26%) 
Thyroid cancer  1  0/394 (0.00%)  1/392 (0.26%) 
Nervous system disorders     
Convulsion  1  0/394 (0.00%)  2/392 (0.51%) 
Syncope  1  1/394 (0.25%)  1/392 (0.26%) 
Transient ischaemic attack  1  1/394 (0.25%)  1/392 (0.26%) 
Cerebrovascular accident  1  1/394 (0.25%)  0/392 (0.00%) 
Headache  1  0/394 (0.00%)  1/392 (0.26%) 
Partial seizures  1  0/394 (0.00%)  1/392 (0.26%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/394 (0.25%)  0/392 (0.00%) 
Psychiatric disorders     
Depression  1  2/394 (0.51%)  2/392 (0.51%) 
Suicide attempt  1  1/394 (0.25%)  3/392 (0.77%) 
Major depression  1  2/394 (0.51%)  1/392 (0.26%) 
Suicidal ideation  1  2/394 (0.51%)  1/392 (0.26%) 
Bipolar I disorder  1  1/394 (0.25%)  1/392 (0.26%) 
Alcohol abuse  1  1/394 (0.25%)  0/392 (0.00%) 
Completed suicide  1  0/394 (0.00%)  1/392 (0.26%) 
Delirium tremens  1  0/394 (0.00%)  1/392 (0.26%) 
Mental status changes  1  1/394 (0.25%)  0/392 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  2/394 (0.51%)  1/392 (0.26%) 
Reproductive system and breast disorders     
Cervical dysplasia  1  0/394 (0.00%)  1/392 (0.26%) 
Epididymitis  1  0/394 (0.00%)  1/392 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Asphyxia  1  0/394 (0.00%)  1/392 (0.26%) 
Epistaxis  1  1/394 (0.25%)  0/392 (0.00%) 
Pulmonary embolism  1  1/394 (0.25%)  0/392 (0.00%) 
Skin and subcutaneous tissue disorders     
Leukocytoclastic vasculitis  1  1/394 (0.25%)  0/392 (0.00%) 
Vascular disorders     
Accelerated hypertension  1  0/394 (0.00%)  1/392 (0.26%) 
Behcet’s syndrome  1  1/394 (0.25%)  0/392 (0.00%) 
Deep vein thrombosis  1  1/394 (0.25%)  0/392 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TDF EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   300/394 (76.14%)   322/392 (82.14%) 
Gastrointestinal disorders     
Diarrhoea  1  69/394 (17.51%)  78/392 (19.90%) 
Nausea  1  65/394 (16.50%)  65/392 (16.58%) 
Vomiting  1  20/394 (5.08%)  21/392 (5.36%) 
Flatulence  1  24/394 (6.09%)  9/392 (2.30%) 
General disorders     
Fatigue  1  42/394 (10.66%)  54/392 (13.78%) 
Pyrexia  1  16/394 (4.06%)  22/392 (5.61%) 
Infections and infestations     
Upper respiratory tract infection  1  57/394 (14.47%)  72/392 (18.37%) 
Nasopharyngitis  1  33/394 (8.38%)  39/392 (9.95%) 
Bronchitis  1  34/394 (8.63%)  29/392 (7.40%) 
Sinusitis  1  28/394 (7.11%)  19/392 (4.85%) 
Syphilis  1  26/394 (6.60%)  18/392 (4.59%) 
Folliculitis  1  27/394 (6.85%)  8/392 (2.04%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/394 (2.54%)  20/392 (5.10%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  28/394 (7.11%)  23/392 (5.87%) 
Back pain  1  20/394 (5.08%)  25/392 (6.38%) 
Myalgia  1  20/394 (5.08%)  13/392 (3.32%) 
Nervous system disorders     
Dizziness  1  27/394 (6.85%)  90/392 (22.96%) 
Headache  1  56/394 (14.21%)  61/392 (15.56%) 
Somnolence  1  9/394 (2.28%)  30/392 (7.65%) 
Psychiatric disorders     
Abnormal dreams  1  23/394 (5.84%)  101/392 (25.77%) 
Insomnia  1  45/394 (11.42%)  60/392 (15.31%) 
Depression  1  34/394 (8.63%)  47/392 (11.99%) 
Anxiety  1  28/394 (7.11%)  37/392 (9.44%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/394 (9.64%)  27/392 (6.89%) 
Oropharyngeal pain  1  23/394 (5.84%)  15/392 (3.83%) 
Skin and subcutaneous tissue disorders     
Rash  1  31/394 (7.87%)  51/392 (13.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01309243     History of Changes
Other Study ID Numbers: GS-US-264-0110
First Submitted: March 3, 2011
First Posted: March 7, 2011
Results First Submitted: September 25, 2013
Results First Posted: November 27, 2013
Last Update Posted: February 25, 2015