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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01309243
First received: March 3, 2011
Last updated: February 3, 2015
Last verified: February 2015
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: FTC/RPV/TDF
Drug: EFV/FTC/TDF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
991 participants were screened.

Reporting Groups
  Description
FTC/RPV/TDF Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
EFV/FTC/TDF Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily

Participant Flow for 2 periods

Period 1:   Randomized Phase Through Week 96
    FTC/RPV/TDF     EFV/FTC/TDF  
STARTED     400     399  
Randomized and Treated     394     392  
COMPLETED     316     290  
NOT COMPLETED     84     109  
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 2:   Extension Phase
    FTC/RPV/TDF     EFV/FTC/TDF  
STARTED     40 [1]   117 [2]
COMPLETED     34     117  
NOT COMPLETED     6     0  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.

Reporting Groups
  Description
FTC/RPV/TDF FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV/FTC/TDF EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
Total Total of all reporting groups

Baseline Measures
    FTC/RPV/TDF     EFV/FTC/TDF     Total  
Number of Participants  
[units: participants]
  394     392     786  
Age  
[units: years]
Mean (Standard Deviation)
  37  (10.4)     37  (11.0)     37  (10.7)  
Gender  
[units: participants]
     
Female     28     28     56  
Male     366     364     730  
Race/Ethnicity, Customized  
[units: 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  
[units: 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]
[units: 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  
HIV-1 RNA  
[units: log10┬ácopies/mL]
Mean (Standard Deviation)
  4.8  (0.65)     4.8  (0.61)     4.8  (0.63)  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     260     250     510  
> 100,000 copies/mL     134     142     276  
Cluster of differentiation 4 (CD4) Cell Count  
[units: cells/μL]
Mean (Standard Deviation)
  395.7  (179.64)     385.2  (186.82)     390.5  (183.21)  
Use of lipid-lowering agent  
[units: participants]
     
Yes     4     1     5  
No     390     391     781  
[1] All randomized participants were analyzed for Region of Enrollment



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Baseline to Week 96 ]

3.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline to Week 96 ]

5.  Secondary:   Change From Baseline in Fasting Total Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

6.  Secondary:   Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

7.  Secondary:   Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48   [ Time Frame: Baseline to Week 48 ]

8.  Secondary:   Change From Baseline in Fasting Triglycerides at Week 48   [ Time Frame: Baseline to Week 48 ]

9.  Secondary:   Development of HIV-1 Drug Resistance Through Week 96, All Participants   [ Time Frame: Baseline to Week 96 ]

10.  Secondary:   Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance   [ Time Frame: Baseline to Week 96 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Additional Description Safety Analysis Set

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
FTC/RPV/TDF FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
EFV/FTC/TDF EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily

Other Adverse Events
    FTC/RPV/TDF     EFV/FTC/TDF  
Total, other (not including serious) adverse events      
# participants affected / at risk     300/394 (76.14%)     322/392 (82.14%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     69/394 (17.51%)     78/392 (19.90%)  
Nausea † 1    
# participants affected / at risk     65/394 (16.50%)     65/392 (16.58%)  
Vomiting † 1    
# participants affected / at risk     20/394 (5.08%)     21/392 (5.36%)  
Flatulence † 1    
# participants affected / at risk     24/394 (6.09%)     9/392 (2.30%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     42/394 (10.66%)     54/392 (13.78%)  
Pyrexia † 1    
# participants affected / at risk     16/394 (4.06%)     22/392 (5.61%)  
Infections and infestations      
Upper respiratory tract infection † 1    
# participants affected / at risk     57/394 (14.47%)     72/392 (18.37%)  
Nasopharyngitis † 1    
# participants affected / at risk     33/394 (8.38%)     39/392 (9.95%)  
Bronchitis † 1    
# participants affected / at risk     34/394 (8.63%)     29/392 (7.40%)  
Sinusitis † 1    
# participants affected / at risk     28/394 (7.11%)     19/392 (4.85%)  
Syphilis † 1    
# participants affected / at risk     26/394 (6.60%)     18/392 (4.59%)  
Folliculitis † 1    
# participants affected / at risk     27/394 (6.85%)     8/392 (2.04%)  
Metabolism and nutrition disorders      
Decreased appetite † 1    
# participants affected / at risk     10/394 (2.54%)     20/392 (5.10%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     28/394 (7.11%)     23/392 (5.87%)  
Back pain † 1    
# participants affected / at risk     20/394 (5.08%)     25/392 (6.38%)  
Myalgia † 1    
# participants affected / at risk     20/394 (5.08%)     13/392 (3.32%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     27/394 (6.85%)     90/392 (22.96%)  
Headache † 1    
# participants affected / at risk     56/394 (14.21%)     61/392 (15.56%)  
Somnolence † 1    
# participants affected / at risk     9/394 (2.28%)     30/392 (7.65%)  
Psychiatric disorders      
Abnormal dreams † 1    
# participants affected / at risk     23/394 (5.84%)     101/392 (25.77%)  
Insomnia † 1    
# participants affected / at risk     45/394 (11.42%)     60/392 (15.31%)  
Depression † 1    
# participants affected / at risk     34/394 (8.63%)     47/392 (11.99%)  
Anxiety † 1    
# participants affected / at risk     28/394 (7.11%)     37/392 (9.44%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     38/394 (9.64%)     27/392 (6.89%)  
Oropharyngeal pain † 1    
# participants affected / at risk     23/394 (5.84%)     15/392 (3.83%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     31/394 (7.87%)     51/392 (13.01%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 16.1



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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