Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00543725 · ClinicalTrials.gov registry record · Phase 3
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
A Phase 3 study of HIV Infections and HIV-1, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 680
- Enrollment target
- 20
- Study locations
NCT00543725: Completed Phase 3 study of HIV Infections and HIV-1, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00543725 is a Phase 3 study of HIV Infections and HIV-1 that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 680 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543725, a Phase 3 study of HIV Infections and HIV-1, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 680 participants
- Enrollment target
- 20
- Study locations
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 background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) 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 and 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
Conditions Studied
Interventions
- DRUG efavirenz
- DRUG TMC278
Study Locations (20)
Florida
- - Atlantis
- - Miami
- - Miami Beach
- - Orlando
- - Tampa
California
- - Long Beach
- - Los Angeles
- - San Francisco
New York
- - Flushing
- - New York
- - Rochester
Massachusetts
- - Boston
- - Springfield
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Kentucky
- - Lexington
Maryland
- - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00543725 record still lists
NCT00543725 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% higher).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which efavirenz is the first listed.
NCT00543725 names 20 study sites across 11 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT00543725 about?
NCT00543725 is a clinical study titled "TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors". 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 background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( invest...
What is the current status of trial NCT00543725?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2008-06. Estimated completion is 2012-02.
What conditions does trial NCT00543725 study?
This clinical trial studies the following conditions: HIV Infections, HIV-1.
What interventions are being tested in trial NCT00543725?
The interventions under investigation include: efavirenz (DRUG), TMC278 (DRUG).
Who is sponsoring clinical trial NCT00543725?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00543725 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00543725's enrollment target sits among peer trials
680 45th of 542 higher than 498 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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
-
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
RECRUITING · Phase 3
-
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
RECRUITING · Phase 3
-
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
RECRUITING · Phase 3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
ACTIVE NOT RECRUITING · Phase 3
-
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03501706 · 680 participants · NA
An Assessment of Cognitive Improvement Training Among Mid-life Individuals
- NCT05626452 · 680 participants · NA
PrEP Optimization Among Women to Enhance Retention and Uptake
- NCT05753748 · 680 participants · NA
Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
- NCT05952141 · 680 participants · NA
Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia