An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
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|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|
|Actual Primary Completion Date :||January 2012|
|Actual 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359021
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|