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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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 ]

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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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Measure Type	Secondary
Measure Title	Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score
Measure Description	The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a "no" or "yes" answer to "Did symptom occur?". If "yes", there is a problem scale which ranges from 1 = "I had this symptom and it was not a problem" to 5 = "I had this symptom and it was a severe problem". A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)
Time Frame	between baseline and week 48
Safety Issue	No

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.
ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.

Reporting Groups

	Description
Etravirine	Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
Efavirenz	Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks

Measured Values

	Etravirine	Efavirenz
Number of Participants Analyzed [units: participants]	75	74
Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score [units: points on a scale] Mean (Standard Error)
Total Tolerability Score	-0.04 (0.03)	-0.01 (0.04)
Neuropsychiatric Tolerability Score	-0.04 (0.06)	-0.07 (0.07)

No statistical analysis provided for Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score

5. Secondary:

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

Show Outcome Measure 5

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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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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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A copy of the manuscript must be provided to the Sponsor for review at least 60 days prior to submission for publication or presentation. No paper that incorporates Confidential Information will be submitted for publication without Sponsor’s prior written consent. If requested in writing, such publication will be withheld for up to an additional 60 calendar days. A publication from the individual Study site data will not be published until the combined results have been published.

Results Point of Contact:

Name/Title: EMEA Medical Affairs Director Virology
Organization: Janssen-Cilag EMEA
phone: +31 6 542 454 37

Publications of Results:

Nelson M, Stellbrink HJ, Podzamczer D, Banhegyi D, Gazzard B, Hill A, van Delft Y, Vingerhoets J, Stark T, Marks S. A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. AIDS. 2011 Jan 28;25(3):335-40. doi: 10.1097/QAD.0b013e3283416873.

Gazzard B, Duvivier C, Zagler C, Castagna A, Hill A, van Delft Y, Marks S. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results. AIDS. 2011 Nov 28;25(18):2249-58. doi: 10.1097/QAD.0b013e32834c4c06.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fätkenheuer G, Duvivier C, Rieger A, Durant J, Rey D, Schmidt W, Hill A, van Delft Y, Marks S; SENSE Study Team. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. J Antimicrob Chemother. 2012 Mar;67(3):685-90. doi: 10.1093/jac/dkr533. Epub 2011 Dec 29.

Responsible Party:	Janssen-Cilag International NV
ClinicalTrials.gov Identifier:	NCT00903682 History of Changes
Other Study ID Numbers:	CR015751 TMC125VIR2038 ( Other Identifier: Janssen-Cilag International NV ) 2008-008655-42 ( EudraCT Number )
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

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