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
A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects
3 other identifiers
interventional
157
11 countries
33
Brief Summary
The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
March 7, 2011
CompletedJanuary 14, 2013
January 1, 2013
8 months
May 14, 2009
February 10, 2011
January 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event
Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE grading table"). Grade 1-4 covers all severities.
between baseline and 12 weeks
Secondary Outcomes (6)
Antiviral Activity of ETR vs. EFV
between baseline and week 48
Antiviral Activity of ETR vs. EFV
between baseline and week 48
Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score
between baseline and week 48
Neuropsychiatric Adverse Events by Week 48
from baseline to week 48
Mean Change From Baseline in CD4+ Cell Count
at baseline and week 2, 6, 12, 24, 36 and 48
- +1 more secondary outcomes
Study Arms (2)
etravirine
EXPERIMENTALetravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
efavirenz
ACTIVE COMPARATORefavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
Interventions
400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
Eligibility Criteria
You may qualify if:
- Documented HIV-1 infection
- In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection
- Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection
- HIV-1 plasma viral load at screening \>= 5000 HIV-1 RNA (copies/ml)
- Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening
You may not qualify if:
- Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
- The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance
- Known infection with HIV-2 or with HIV-1 group O
- Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive
- Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured
- Specific grade 3 or 4 laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Salzburg, Austria
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Vienna, Austria
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Aarhus, Denmark
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Odense, Denmark
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Bordeaux, France
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Lyon, France
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Nice, France
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Paris, France
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Strasbourg, France
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Berlin, Germany
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Bonn, Germany
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Cologne, Germany
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Essen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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Budapest, Hungary
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Bucharest, Romania
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Constanța, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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Barcelona, Spain
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Granada, Spain
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Madrid, Spain
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Vigo, Spain
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Bern, Switzerland
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Zurich, Switzerland
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Brighton, United Kingdom
Unknown Facility
London, United Kingdom
Related Publications (3)
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.
PMID: 21150563RESULTGazzard 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.
PMID: 21881478RESULTFatkenheuer 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.
PMID: 22210755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMEA Medical Affairs Director Virology
- Organization
- Janssen-Cilag EMEA
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2010
Study Completion
January 1, 2011
Last Updated
January 14, 2013
Results First Posted
March 7, 2011
Record last verified: 2013-01