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NCT00540449 · ClinicalTrials.gov registry record · Phase 3
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
A Phase 3 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 694
- Enrollment target
NCT00540449: Completed Phase 3 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00540449 is a Phase 3 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 694 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00540449, a Phase 3 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 694 participants
- Enrollment target
Study Summary
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.
Primary Outcome
Virological response is defined as confirmed plasma viral load less than (\<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid \[RNA\]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants
Interventions
- DRUG Efavirenz
- DRUG TMC278
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 694 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00540449 record still lists
NCT00540449 is an interventional study that assigns participants to a tested intervention. The registered 694 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 (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Efavirenz is the first listed.
NCT00540449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00540449 about?
NCT00540449 is a clinical study titled "TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.". The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF...
What is the current status of trial NCT00540449?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 694 participants. The study started on 2008-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00540449?
The interventions under investigation include: Efavirenz (DRUG), TMC278 (DRUG).
Who is sponsoring clinical trial NCT00540449?
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 NCT00540449's enrollment target sits among peer trials
694 519th of 2000 higher than 1,482 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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