Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
211 participants
INTERVENTIONAL
2004-03-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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TMC125
Eligibility Criteria
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Inclusion Criteria
* Documented genotypic evidence of resistance to currently available NNRTIs
* Previous NRTI experience for at least 3 months
* 3 primary PI mutations at screening
Exclusion Criteria
* Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
* Previous permanent discontinuation of any NNRTI due to cutaneous events.
18 Years
ALL
No
Sponsors
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Tibotec Pharmaceuticals, Ireland
INDUSTRY
Principal Investigators
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Tibotec Pharmaceuticals Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceutical Limited
References
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Cohen CJ, Berger DS, Blick G, Grossman HA, Jayaweera DT, Shalit P, Thompson M, Peeters M, de Bethune MP, Voorspoels E, Mack R, Woodfall B. Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial. AIDS. 2009 Jan 28;23(3):423-6. doi: 10.1097/QAD.0b013e32831c5040.
Other Identifiers
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CR006736
Identifier Type: -
Identifier Source: org_study_id
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