Phase 3
Completed N=503
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
Source: ClinicalTrials.gov NCT00359021 ↗Enrolled (actual)
503
Serious AEs
17.5%
Results posted
Mar 2013
Primary outcomePrimary: The Number of Participants Experiencing Adverse Events — 46; 42; 88; 160 Participants
Summary
The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Adverse Events |
46; 42; 88; 160; 137; 297 | — |
| SECONDARY The Percentage of Participants With Virologic Outcomes Over Time |
43.0; 62.3; 46.9; 31.6; 10.2; 6.1 | — |
| SECONDARY Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time) |
-0.8; 0; -0.7; -0.1; -0.5; -0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
- Patient was virologically failing in a DUET trial.
Exclusion Criteria
- Use of disallowed concomitant therapy
- Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
- Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.
Data sourced from ClinicalTrials.gov (NCT00359021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.