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 28, 2014
Last verified: February 2014
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 for the Week 48 analysis was on 18 September 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
901 participants were screened and 799 were randomized; 786 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to receive emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF)
EFV/FTC/TDF Participants were randomized to receive efavirenz (EFV)/FTC/TDF

Participant Flow:   Overall Study
    FTC/RPV/TDF     EFV/FTC/TDF  
STARTED     400     399  
Randomized and Treated     394     392  
Discontinued Prior to Week 48     37     50  
COMPLETED     0     0  
NOT COMPLETED     400     399  
Randomized but not treated                 6                 7  
Adverse Event                 4                 12  
Death                 0                 1  
Lack of Efficacy                 5                 1  
Physician Decision                 2                 3  
Withdrawal by Subject                 5                 16  
Lost to Follow-up                 15                 13  
Subject Non-Compliance                 5                 4  
Protocol Violation                 1                 0  
Subject Still on Study at Week 48                 357                 342  



  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 Participants were randomized to receive FTC/RPV/TDF
EFV/FTC/TDF Participants were randomized to receive EFV/FTC/TDF
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     22     31     53  
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  
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-modifying agent  
[units: participants]
     
Yes     52     54     106  
No     342     338     680  
[1] All randomized participants were analyzed for Region of Enrollment



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

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

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

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

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

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

7.  Secondary:   Development of HIV-1 Genotypic Resistance Through Week 48, All Participants   [ Time Frame: Baseline to Week 48 ]

8.  Secondary:   Development of HIV-1 Genotypic Resistance Through Week 48, Participants With Viral Resistance   [ Time Frame: Baseline to Week 48 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Baseline to Week 48
Additional Description No text entered.

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

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to receive FTC/RPV/TDF
EFV/FTC/TDF Participants were randomized to receive EFV/FTC/TDF

Other Adverse Events
    FTC/RPV/TDF     EFV/FTC/TDF  
Total, other (not including serious) adverse events      
# participants affected / at risk     259/394     300/392  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     56/394 (14.21%)     70/392 (17.86%)  
Nausea † 1    
# participants affected / at risk     58/394 (14.72%)     59/392 (15.05%)  
Flatulence † 1    
# participants affected / at risk     23/394 (5.84%)     8/392 (2.04%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     36/394 (9.14%)     49/392 (12.50%)  
Infections and infestations      
Upper respiratory tract infection † 1    
# participants affected / at risk     38/394 (9.64%)     47/392 (11.99%)  
Nasopharyngitis † 1    
# participants affected / at risk     21/394 (5.33%)     26/392 (6.63%)  
Bronchitis † 1    
# participants affected / at risk     21/394 (5.33%)     24/392 (6.12%)  
Sinusitis † 1    
# participants affected / at risk     21/394 (5.33%)     12/392 (3.06%)  
Folliculitis † 1    
# participants affected / at risk     21/394 (5.33%)     4/392 (1.02%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     23/394 (5.84%)     21/392 (5.36%)  
Back pain † 1    
# participants affected / at risk     14/394 (3.55%)     20/392 (5.10%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     26/394 (6.60%)     87/392 (22.19%)  
Headache † 1    
# participants affected / at risk     49/394 (12.44%)     52/392 (13.27%)  
Somnolence † 1    
# participants affected / at risk     10/394 (2.54%)     27/392 (6.89%)  
Psychiatric disorders      
Abnormal dreams † 1    
# participants affected / at risk     23/394 (5.84%)     96/392 (24.49%)  
Insomnia † 1    
# participants affected / at risk     38/394 (9.64%)     55/392 (14.03%)  
Depression † 1    
# participants affected / at risk     24/394 (6.09%)     34/392 (8.67%)  
Anxiety † 1    
# participants affected / at risk     20/394 (5.08%)     33/392 (8.42%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     29/394 (7.36%)     22/392 (5.61%)  
Oropharyngeal pain † 1    
# participants affected / at risk     20/394 (5.08%)     12/392 (3.06%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     24/394 (6.09%)     47/392 (11.99%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (15.0)



  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
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01309243     History of Changes
Other Study ID Numbers: GS-US-264-0110
Study First Received: March 3, 2011
Results First Received: September 25, 2013
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration