Status:
COMPLETED
TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will al...
Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen contai...
Eligibility Criteria
Inclusion
- Patient has 3 or more primary protease inhibitor mutations
- documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
- on a stable antiretroviral therapy for at least 8 weeks
- plasma viral load at screening visit \> 5000 HIV-1 RNA copies/mL.
Exclusion
- Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
- Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
- Use of disallowed concurrent therapy
- Any active clinically significant disease
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
593 Patients enrolled
Trial Details
Trial ID
NCT00255099
Start Date
December 1 2005
End Date
July 1 2008
Last Update
June 15 2011
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