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NCT00110305 · ClinicalTrials.gov registry record · Phase 2
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 368
- Enrollment target
NCT00110305: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00110305 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 368 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110305, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 368 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
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. 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 considered as failure in t
Interventions
- DRUG Efavirenz
- DRUG TMC278 25 mg
- DRUG TMC278 75 mg
- DRUG TMC278 150 mg
- DRUG Non-nucleoside reverse transcriptase inhibitor (NRTIs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00110305 record still lists
NCT00110305 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 5 interventions - of which Efavirenz is the first listed.
NCT00110305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00110305 about?
NCT00110305 is a clinical study titled "A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines". The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
What is the current status of trial NCT00110305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 368 participants. The study started on 2005-06. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00110305?
The interventions under investigation include: Efavirenz (DRUG), TMC278 25 mg (DRUG), TMC278 75 mg (DRUG), TMC278 150 mg (DRUG), Non-nucleoside reverse transcriptase inhibitor (NRTIs) (DRUG).
Who is sponsoring clinical trial NCT00110305?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00110305's enrollment target sits among peer trials
368 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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