ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01709084
Recruitment Status : Active, not recruiting
First Posted : October 17, 2012
Results First Posted : January 5, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus-type 1 Infection
Interventions Drug: Rilpivirine
Drug: Efavirenz
Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine
Enrollment 426

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 213 213
Treated 213 211
Completed 197 198
Not Completed 16 15
Reason Not Completed
Lost to Follow-up             4             7
Withdrawal by Subject             2             2
Adverse Event             5             0
Other             5             3
Participant Reached a Virologic Endpoint             0             1
Not Treated             0             2
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 213 211 424
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants 211 participants 424 participants
40.6  (8) 40.6  (8.7) 40.6  (8.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
Female
137
  64.3%
134
  63.5%
271
  63.9%
Male
76
  35.7%
77
  36.5%
153
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 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
1.Primary Outcome
Title 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
Hide Description Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Unit of Measure: Percentage of Participants
93.9 96.2
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
Hide Description Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Unit of Measure: Percentage of Participants
93.9 96.2
3.Secondary Outcome
Title 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.
Hide Description Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 205
Measure Type: Number
Unit of Measure: Percentage of Participants
0.5 0.5
4.Secondary Outcome
Title 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.
Hide Description Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 205
Measure Type: Number
Unit of Measure: Percentage of Participants
1.5 1.0
5.Secondary Outcome
Title Percentage of Participant With Treatment Adherence Based on Tablet Count
Hide Description In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).
Time Frame Up to 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 207 206
Measure Type: Number
Unit of Measure: Percentage of Participants
97.2 97.6
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
Hide Description To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.
Time Frame Up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TDF/FTC/RPV TDF/FTC/EFV
Hide Arm/Group Description 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. 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.
All-Cause Mortality
TDF/FTC/RPV TDF/FTC/EFV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TDF/FTC/RPV TDF/FTC/EFV
Affected / at Risk (%) Affected / at Risk (%)
Total   16/213 (7.51%)   11/211 (5.21%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/213 (0.00%)  1/211 (0.47%) 
Neutropenia * 1  0/213 (0.00%)  1/211 (0.47%) 
Cardiac disorders     
Myocardial Infarction * 1  1/213 (0.47%)  0/211 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Inflammation * 1  0/213 (0.00%)  1/211 (0.47%) 
Immune system disorders     
Food Allergy * 1  0/213 (0.00%)  1/211 (0.47%) 
Infections and infestations     
Appendicitis * 1  1/213 (0.47%)  0/211 (0.00%) 
Gastroenteritis * 1  1/213 (0.47%)  0/211 (0.00%) 
Influenza * 1  1/213 (0.47%)  0/211 (0.00%) 
Neurocysticercosis * 1  1/213 (0.47%)  0/211 (0.00%) 
Neurosyphilis * 1  1/213 (0.47%)  0/211 (0.00%) 
Pneumonia * 1  1/213 (0.47%)  0/211 (0.00%) 
Sinusitis * 1  0/213 (0.00%)  1/211 (0.47%) 
Injury, poisoning and procedural complications     
Ankle Fracture * 1  1/213 (0.47%)  0/211 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/213 (0.47%)  0/211 (0.00%) 
Metabolism and nutrition disorders     
Diabetes Mellitus * 1  3/213 (1.41%)  0/211 (0.00%) 
Hyperglycaemia * 1  2/213 (0.94%)  0/211 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer * 1  0/213 (0.00%)  1/211 (0.47%) 
Cervix Carcinoma * 1  0/213 (0.00%)  1/211 (0.47%) 
Uterine Leiomyoma * 1  1/213 (0.47%)  0/211 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous * 1  2/213 (0.94%)  1/211 (0.47%) 
Reproductive system and breast disorders     
Adenomyosis * 1  0/213 (0.00%)  1/211 (0.47%) 
Endometriosis * 1  0/213 (0.00%)  1/211 (0.47%) 
Gynaecomastia * 1  0/213 (0.00%)  1/211 (0.47%) 
Uterine Haemorrhage * 1  0/213 (0.00%)  1/211 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TDF/FTC/RPV TDF/FTC/EFV
Affected / at Risk (%) Affected / at Risk (%)
Total   128/213 (60.09%)   137/211 (64.93%) 
Blood and lymphatic system disorders     
Neutropenia * 1  8/213 (3.76%)  12/211 (5.69%) 
Ear and labyrinth disorders     
Vertigo * 1  11/213 (5.16%)  19/211 (9.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  8/213 (3.76%)  11/211 (5.21%) 
Infections and infestations     
Malaria * 1  10/213 (4.69%)  22/211 (10.43%) 
Upper Respiratory Tract Infection * 1  63/213 (29.58%)  59/211 (27.96%) 
Urinary Tract Infection * 1  29/213 (13.62%)  28/211 (13.27%) 
Investigations     
Amylase Increased * 1  14/213 (6.57%)  5/211 (2.37%) 
Blood Pressure Increased * 1  13/213 (6.10%)  9/211 (4.27%) 
Metabolism and nutrition disorders     
Increased Appetite * 1  11/213 (5.16%)  3/211 (1.42%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  17/213 (7.98%)  15/211 (7.11%) 
Back Pain * 1  20/213 (9.39%)  14/211 (6.64%) 
Nervous system disorders     
Dizziness * 1  7/213 (3.29%)  14/211 (6.64%) 
Headache * 1  38/213 (17.84%)  29/211 (13.74%) 
Somnolence * 1  11/213 (5.16%)  3/211 (1.42%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  19/213 (8.92%)  7/211 (3.32%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  14/213 (6.57%)  10/211 (4.74%) 
Vascular disorders     
Hypertension * 1  5/213 (2.35%)  13/211 (6.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
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.
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: Director, R&D, Medical Departement
Organization: Janssen R&D US
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 )
First Submitted: October 16, 2012
First Posted: October 17, 2012
Results First Submitted: October 5, 2016
Results First Posted: January 5, 2017
Last Update Posted: May 1, 2018