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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

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 
Overall Participants Analyzed 
[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 
[1] All randomized participants were analyzed for Region of Enrollment
HIV-1 RNA 
[Units: Log10 copies/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 


  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
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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

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

Serious Adverse Events
    FTC/RPV/TDF   EFV/FTC/TDF
Total, serious adverse events     
# participants affected / at risk   36/394 (9.14%)   48/392 (12.24%) 
Blood and lymphatic system disorders     
Haemolytic anaemia † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Cardiac disorders     
Myocardial infarction † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Tachycardia † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Gastrointestinal disorders     
Rectal haemorrhage † 1     
# participants affected / at risk   0/394 (0.00%)   2/392 (0.51%) 
Abdominal pain † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Anal fistula † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Colitis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Gastritis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Inguinal hernia † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Large intestine perforation † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Vomiting † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
General disorders     
Chest pain † 1     
# participants affected / at risk   2/394 (0.51%)   0/392 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   0/394 (0.00%)   2/392 (0.51%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Cholelithiasis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Liver injury † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Immune system disorders     
Anaphylactic reaction † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Hypersensitivity † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Infections and infestations     
Appendicitis † 1     
# participants affected / at risk   2/394 (0.51%)   0/392 (0.00%) 
Cellulitis † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Gastroenteritis † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Neurosyphilis † 1     
# participants affected / at risk   0/394 (0.00%)   2/392 (0.51%) 
Ophthalmic herpes zoster † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Abscess limb † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Anal abscess † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Arthritis bacterial † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Atypical pneumonia † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Bronchitis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Eye infection syphilitic † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Furuncle † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Gastroenteritis shigella † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Meningitis aseptic † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Meningitis viral † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Rectal abscess † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Secondary syphilis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Sepsis † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Septic shock † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Staphylococcal bacteraemia † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Staphylococcal infection † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Injury, poisoning and procedural complications     
Concussion † 1     
# participants affected / at risk   2/394 (0.51%)   0/392 (0.00%) 
Ankle fracture † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Clavicle fracture † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Fall † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Femoral neck fracture † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Limb injury † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Patella fracture † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Radius fracture † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Tendon rupture † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Upper limb fracture † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Wrist fracture † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Investigations     
Hepatic enzyme increased † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Musculoskeletal and connective tissue disorders     
Arthritis reactive † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Back pain † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Tenosynovitis † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Burkitt’s lymphoma † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Anal squamous cell carcinoma † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Anogenital warts † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Craniopharyngioma † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Gliosarcoma † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Prostate cancer † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Rectal cancer stage 0 † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Testicular germ cell cancer † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Thyroid cancer † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Nervous system disorders     
Convulsion † 1     
# participants affected / at risk   0/394 (0.00%)   2/392 (0.51%) 
Syncope † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Transient ischaemic attack † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Cerebrovascular accident † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Headache † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Partial seizures † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Psychiatric disorders     
Depression † 1     
# participants affected / at risk   2/394 (0.51%)   2/392 (0.51%) 
Suicide attempt † 1     
# participants affected / at risk   1/394 (0.25%)   3/392 (0.77%) 
Major depression † 1     
# participants affected / at risk   2/394 (0.51%)   1/392 (0.26%) 
Suicidal ideation † 1     
# participants affected / at risk   2/394 (0.51%)   1/392 (0.26%) 
Bipolar I disorder † 1     
# participants affected / at risk   1/394 (0.25%)   1/392 (0.26%) 
Alcohol abuse † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Completed suicide † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Delirium tremens † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Mental status changes † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis † 1     
# participants affected / at risk   2/394 (0.51%)   1/392 (0.26%) 
Reproductive system and breast disorders     
Cervical dysplasia † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Epididymitis † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Asphyxia † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Epistaxis † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Pulmonary embolism † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Skin and subcutaneous tissue disorders     
Leukocytoclastic vasculitis † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Vascular disorders     
Accelerated hypertension † 1     
# participants affected / at risk   0/394 (0.00%)   1/392 (0.26%) 
Behcet’s syndrome † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Deep vein thrombosis † 1     
# participants affected / at risk   1/394 (0.25%)   0/392 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 16.1




  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
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