Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Human Immunodeficiency Virus - Type 1, sponsored by Tibotec Pharmaceuticals, Ireland.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was cons
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 |
What the finished NCT00524368 record still lists
NCT00524368 is an interventional study that assigns participants to a tested intervention. The registered 590 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00524368's enrollment target sits among peer trials
590 643rd of 2000 higher than 1,356 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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
- NCT01365169 · 590 participants · NA
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
- NCT03774758 · 590 participants
Biomarkers for Risk Stratification in Lung Cancer
- NCT04747626 · 590 participants · NA
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
- NCT05722938 · 590 participants · Phase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
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