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NCT00359021 · ClinicalTrials.gov registry record · Phase 3
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
A Phase 3 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT00359021: Completed Phase 3 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00359021 is a Phase 3 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 503 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359021, a Phase 3 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG TMC125
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2006-06 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00359021 record still lists
NCT00359021 is an interventional study that assigns participants to a tested intervention. The registered 503 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which TMC125 is the first listed.
NCT00359021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00359021 about?
NCT00359021 is a clinical study titled "An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).". 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 TMC...
What is the current status of trial NCT00359021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2006-06. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00359021?
The interventions under investigation include: TMC125 (DRUG).
Who is sponsoring clinical trial NCT00359021?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00359021's enrollment target sits among peer trials
503 743rd of 2000 higher than 1,258 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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