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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 is a Phase 3 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 503 participants.
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.
Interventions
- DRUG TMC125
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2006-06 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00359021
The ClinicalTrials.gov registry entry for NCT00359021 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 503 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TMC125 is the first listed.
NCT00359021 reports 0 study locations.
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.
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