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NCT00258557 · ClinicalTrials.gov registry record · Phase 3
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
A Phase 3 study of HIV, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 692
- Enrollment target
- 20
- Study locations
NCT00258557: Completed Phase 3 study of HIV, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00258557 is a Phase 3 study of HIV that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 692 participants, above the 438-participant average among 303 other HIV trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258557, a Phase 3 study of HIV, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 692 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).
Conditions Studied
Interventions
- DRUG LPV/RTV
- DRUG TMC-114/RTV
Study Locations (20)
Florida
- - Fort Lauderdale
- - Jacksonville
- - Miami
- - Miami Beach
- - Orlando
- - Safety Harbor
- - Tampa
- - Vero Beach
California
- - Beverly Hills
- - Long Beach
- - Los Angeles
- - Sacramento
- - San Francisco
Arizona
- - Phoenix
District of Columbia
- - Washington D.C.
Maryland
- - Baltimore
Massachusetts
- - Boston
Nevada
- - Las Vegas
New York
- - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 692 participants |
| Start Date | 2005-09 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00258557 record still lists
NCT00258557 is an interventional study that assigns participants to a tested intervention. The registered 692 participants enrollment target is mid-sized for trials with a published cap, above the 438-participant average among 303 other HIV trials with a reported enrollment target (58% higher).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which LPV/RTV is the first listed.
NCT00258557 names 20 study sites across 9 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00258557 about?
NCT00258557 is a clinical study titled "TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.". The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).
What is the current status of trial NCT00258557?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 692 participants. The study started on 2005-09. Estimated completion is 2012-05.
What conditions does trial NCT00258557 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT00258557?
The interventions under investigation include: LPV/RTV (DRUG), TMC-114/RTV (DRUG).
Who is sponsoring clinical trial NCT00258557?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00258557 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00258557's enrollment target sits among peer trials
692 29th of 303 higher than 275 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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.
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