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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 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.

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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.

Conditions Studied

HIV Infections HIV-1

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

FieldValue
Enrollment Target 680 participants
Start Date 2008-06
Est. Completion 2012-02
Phase Phase 3

Sponsor

Tibotec Pharmaceuticals, Ireland

16 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00543725

The ClinicalTrials.gov registry entry for NCT00543725 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% higher). The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.