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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00258557
The ClinicalTrials.gov registry entry for NCT00258557 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 692 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 438-participant average among 303 other HIV trials with a reported enrollment target (58% higher). The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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