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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 is a Phase 3 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 694 participants.
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.
Interventions
- DRUG Efavirenz
- DRUG TMC278
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 694 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00540449
The ClinicalTrials.gov registry entry for NCT00540449 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 694 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 2 interventions - of which Efavirenz is the first listed.
NCT00540449 reports 0 study locations.
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.
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