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This is a Phase II, open-label, roll-over trial to evaluate the long-term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy (ART), in HIV-1 infected subjects. In addition, the antiviral activity and immunologic effect of TMC125 as part of an ART over time, and the genotypic and phenotypic changes over time will be evaluated.
This is a Phase II, open-label, roll-over trial to evaluate the long-term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy (ART), in HIV-1 infected subjects. In addition, the antiviral activity and immunologic effect of TMC125 as part of an ART over time, and the genotypic and phenotypic changes over time will be evaluated. Patient who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial, were treated for at least 48 weeks with TMC125, and who may derive continued benefit from TMC125 therapy, as judged by the investigator, can be enrolled. Based on the currently selected trials approximately 300 subjects can be enrolled in the current trial. 800mg twice daily of TMC125 (formulation TF035) and after formulation switch, 200 mg twice daily (formulation F060) will be given in combination with an investigator-selected, optimized underlying therapy (NRTIs and/or allowed PIs and/or T-20). Tolerability and safety will be assessed throughout the trial and the efficacy parameters will be determined at defined time points during the trial. TMC125, 800 mg twice a day and after formulation switch, at 200 mg twice a day
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tibotec Pharmaceuticals, Ireland
Published on BioPortfolio: 2014-08-27T03:52:35-0400
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