An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
|ClinicalTrials.gov Identifier: NCT00359021|
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : March 7, 2013
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV-1||Drug: TMC125||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||503 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).|
|Study Start Date :||June 2006|
|Primary Completion Date :||January 2012|
|Study Completion Date :||January 2012|
TMC125 200 mg twice daily until commercially available
200 mg twice daily until commercially available
- The Number of Participants Experiencing Adverse Events [ Time Frame: 1 week to 180 weeks, with a median of 62 weeks ]The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.
- The Percentage of Participants With Virologic Outcomes Over Time [ Time Frame: Weeks 24, 48, and 96 ]The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).
- Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time) [ Time Frame: Baseline, Week 24, Week 48, and Week 96 ]In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359021
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|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|