TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
Public ClinicalTrials.gov record NCT00540449. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00540449
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 694 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2008 (Type not available)
- Primary completion
- Feb 2010 (Actual)
- Completion
- Dec 2011 (Actual)
- Last update posted
- Mar 29, 2016
2008 – 2011
United States locations
- U.S. sites
- 32
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Beverly Hills | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Newport Beach | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Vero Beach | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Macon | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Newark | New Jersey | — | — |
| Not listed | Albany | New York | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Columbia | South Carolina | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00540449, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2016 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00540449 live on ClinicalTrials.gov.