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NCT00524368 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
A Phase 3 study of Human Immunodeficiency Virus - Type 1, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 590
- Enrollment target
- 20
- Study locations
NCT00524368 is a Phase 3 study of Human Immunodeficiency Virus - Type 1 that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 590 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT00524368, a Phase 3 study of Human Immunodeficiency Virus - Type 1, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 590 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).
Conditions Studied
Interventions
- DRUG Darunavir (DRV)
- DRUG Ritonavir (rtv)
Study Locations (20)
Florida
- - Fort Lauderdale
- - Fort Laudersale
- - Miami
- - Miami Beach
- - Orlando
- - Safety Harbor
- - West Palm Beach
California
- - Beverly Hills
- - Oakland
- - Palm Springs
Georgia
- - Atlanta
- - Macon
- - Savannah
Arizona
- - Phoenix
Arkansas
- - Little Rock
Illinois
- - Chicago
Massachusetts
- - Springfield
Michigan
- - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00524368
The ClinicalTrials.gov registry entry for NCT00524368 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 590 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 1 condition, with Human Immunodeficiency Virus - Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Darunavir (DRV) is the first listed.
NCT00524368 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00524368 about?
NCT00524368 is a clinical study titled "A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)". The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).
What is the current status of trial NCT00524368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 590 participants. The study started on 2007-10. Estimated completion is 2011-10.
What conditions does trial NCT00524368 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus - Type 1.
What interventions are being tested in trial NCT00524368?
The interventions under investigation include: Darunavir (DRV) (DRUG), Ritonavir (rtv) (DRUG).
Who is sponsoring clinical trial NCT00524368?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00524368 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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