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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
History of Changes
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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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 ]
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2.  Secondary:   Antiviral Activity of ETR vs. EFV   [ Time Frame: between baseline and week 48 ]
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3.  Secondary:   Antiviral Activity of ETR vs. EFV   [ Time Frame: between baseline and week 48 ]
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4.  Secondary:   Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score   [ Time Frame: between baseline and week 48 ]
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5.  Secondary:   Neuropsychiatric Adverse Events by Week 48   [ Time Frame: from baseline to week 48 ]
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6.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: at baseline and week 2, 6, 12, 24, 36 and 48 ]
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7.  Secondary:   Resistance Determinations   [ Time Frame: at baseline and all subsequent visits until week 48 in case if virologic failure ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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