A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients (SENSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00903682
First received: May 14, 2009
Last updated: January 7, 2013
Last verified: January 2013
Results First Received: February 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infection
HIV
Acquired Immunodeficiency Syndrome
Interventions: Drug: etravirine (ETR, TMC125)
Drug: efavirenz (EFV)

  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
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Reporting Groups
  Description
Etravirine Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
Efavirenz Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks

Participant Flow:   Overall Study
    Etravirine     Efavirenz  
STARTED     79     78  
COMPLETED     63     63  
NOT COMPLETED     16     15  
Adverse Event                 6                 13  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 5                 0  
Pregnancy                 0                 1  
Subject Reached A Virologic Endpoint                 1                 1  
Subject Non-Compliant                 1                 0  
Patient Couldn't Come For The Visit Due                 1                 0  
For Resistent Profile (Excl Crit 2 Met)                 1                 0  



  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
Etravirine ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
Efavirenz EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
Total Total of all reporting groups

Baseline Measures
    Etravirine     Efavirenz     Total  
Number of Participants  
[units: participants]
  79     78     157  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     78     77     155  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 9.52     37.6  ± 9.82     37.6  ± 9.64  
Gender  
[units: participants]
     
Female     12     18     30  
Male     67     60     127  
Region of Enrollment  
[units: participants]
     
Austria     3     4     7  
Denmark     0     2     2  
France     9     9     18  
Germany     16     13     29  
Hungary     5     3     8  
Israel     4     5     9  
Italy     9     6     15  
Romania     6     10     16  
Russia     9     8     17  
Spain     12     9     21  
Switzerland     1     3     4  
UK     5     6     11  



  Outcome Measures
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1.  Primary:   Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event   [ Time Frame: between baseline and 12 weeks ]

2.  Secondary:   Antiviral Activity of ETR vs. EFV   [ Time Frame: between baseline and week 48 ]

3.  Secondary:   Antiviral Activity of ETR vs. EFV   [ Time Frame: between baseline and week 48 ]

4.  Secondary:   Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score   [ Time Frame: between baseline and week 48 ]

5.  Secondary:   Neuropsychiatric Adverse Events by Week 48   [ Time Frame: from baseline to week 48 ]

6.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: at baseline and week 2, 6, 12, 24, 36 and 48 ]

7.  Secondary:   Resistance Determinations   [ Time Frame: at baseline and all subsequent visits until week 48 in case if virologic failure ]


  Serious Adverse Events
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Time Frame Adverse events represented here were collected between signing of informed consent and the visit at week 48.
Additional Description No text entered.

Reporting Groups
  Description
Etravirine ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
Efavirenz EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks

Serious Adverse Events
    Etravirine     Efavirenz  
Total, serious adverse events      
# participants affected / at risk     11/79 (13.92%)     6/78 (7.69%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Eye disorders      
Conjunctivitis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Gastrointestinal disorders      
Anal Fissure * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Stomatitis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
General disorders      
Pyrexia * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Hepatobiliary disorders      
Cholelithiasis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Infections and infestations      
Pneumonia * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Pulmonary Tuberculosis * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Anal Abscess * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Anogenital Warts * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Secondary Syphilis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Investigations      
Alanine Aminotransferase Increased * 1    
# participants affected / at risk     1/79 (1.27%)     1/78 (1.28%)  
Aspartate Aminotransferase Increased * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Musculoskeletal and connective tissue disorders      
Joint Ankylosis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Basal Cell Carcinoma * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Non-Hodgkin's Lymphoma * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Squamous Cell Carcinoma * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Benign Ovarian Tumour * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Lymphoma * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Uterine Leiomyoma * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Renal and urinary disorders      
Urethral Stenosis * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Pneumothorax * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
Laryngeal Inflammation * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash * 1    
# participants affected / at risk     1/79 (1.27%)     0/78 (0.00%)  
Surgical and medical procedures      
Abortion Induced * 1    
# participants affected / at risk     0/79 (0.00%)     1/78 (1.28%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 12.0




  Other Adverse Events


  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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: EMEA Medical Affairs Director Virology
Organization: Janssen-Cilag EMEA
phone: +31 6 542 454 37


Publications of Results:

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00903682     History of Changes
Other Study ID Numbers: CR015751, TMC125VIR2038, 2008-008655-42
Study First Received: May 14, 2009
Results First Received: February 10, 2011
Last Updated: January 7, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment