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NCT00665847 · ClinicalTrials.gov registry record · Phase 2
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT00665847: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00665847 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665847, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
Primary Outcome
A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=o
Interventions
- DRUG Etravirine (TMC125)
- DRUG Optimized background regimen (OBR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00665847 record still lists
NCT00665847 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Etravirine (TMC125) is the first listed.
NCT00665847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00665847 about?
NCT00665847 is a clinical study titled "TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents". The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
What is the current status of trial NCT00665847?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2008-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00665847?
The interventions under investigation include: Etravirine (TMC125) (DRUG), Optimized background regimen (OBR) (DRUG).
Who is sponsoring clinical trial NCT00665847?
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 NCT00665847's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 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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