A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment (SALIF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01709084
First received: October 16, 2012
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus-type 1 Infection
Interventions: Drug: Rilpivirine
Drug: Efavirenz
Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TDF/FTC/RPV Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
TDF/FTC/EFV Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.

Participant Flow:   Overall Study
    TDF/FTC/RPV   TDF/FTC/EFV
STARTED   213   213 
Treated   213   211 
COMPLETED   197   198 
NOT COMPLETED   16   15 
Lost to Follow-up                4                7 
Withdrawal by Subject                2                2 
Adverse Event                5                0 
unspecified                5                3 
Participant Reached a Virologic Endpoint                0                1 
Not Treated                0                2 



  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.
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Reporting Groups
  Description
TDF/FTC/RPV Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
TDF/FTC/EFV Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
Total Total of all reporting groups

Baseline Measures
   TDF/FTC/RPV   TDF/FTC/EFV   Total 
Overall Participants Analyzed 
[Units: Participants]
 213   211   424 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.6  (8)   40.6  (8.7)   40.6  (8.34) 
Gender 
[Units: Participants]
Count of Participants
     
Female      137  64.3%      134  63.5%      271  63.9% 
Male      76  35.7%      77  36.5%      153  36.1% 
Region of Enrollment 
[Units: Participants]
     
CAMEROON   16   13   29 
KENYA   36   37   73 
SENEGAL   17   8   25 
SOUTH AFRICA   33   30   63 
THAILAND   51   58   109 
UGANDA   60   65   125 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Plasma Human Immunodeficiency Virus – Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48   [ Time Frame: Week 48 ]

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

3.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.   [ Time Frame: Week 48 ]

5.  Secondary:   Percentage of Participant With Treatment Adherence Based on Tablet Count   [ Time Frame: Up to 48 Weeks ]

6.  Secondary:   Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations   [ Time Frame: Up to Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  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
It was an open label switch study with a significant number of patients (55%) on the Efavirenz (EFV) arm who did not switch their Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) unlike in the Rilpivirine (RPV) arm where 100% switched.


  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: Director, R&D, Medical Departement
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01709084     History of Changes
Other Study ID Numbers: CR100875
TMC278IFD3002 ( Other Identifier: Janssen-Cilag International NV )
Study First Received: October 16, 2012
Results First Received: October 5, 2016
Last Updated: November 4, 2016