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)

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. Identifier: NCT00903682
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : March 7, 2011
Last Update Posted : January 14, 2013
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infection
Acquired Immunodeficiency Syndrome
Interventions: Drug: etravirine (ETR, TMC125)
Drug: efavirenz (EFV)

  Participant Flow

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
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

  Outcome Measures

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

  Other Adverse Events

  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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  More Information