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NCT00081588 · ClinicalTrials.gov registry record · Phase 2

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.

Completed
Registry status
Phase 2
Development phase
555
Enrollment target

NCT00081588: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.

NCT00081588 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 555 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (317% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00081588, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.

COMPLETED
Registry status
Phase 2
Development phase
555 participants
Enrollment target

Study Summary

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

Interventions

  • DRUG TMC114

Trial Details

FieldValue
Enrollment Target 555 participants
Start Date 2003-11
Est. Completion 2008-12
Phase Phase 2
Tibotec Pharmaceuticals, Ireland

16 total trials

What the finished NCT00081588 record still lists

NCT00081588 is an interventional study that assigns participants to a tested intervention. The registered 555 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 (317% higher).

The record links to 0 conditions, and to 1 intervention - of which TMC114 is the first listed.

NCT00081588 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00081588 about?

NCT00081588 is a clinical study titled "An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.". The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

What is the current status of trial NCT00081588?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 555 participants. The study started on 2003-11. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00081588?

The interventions under investigation include: TMC114 (DRUG).

Who is sponsoring clinical trial NCT00081588?

This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00081588's enrollment target sits among peer trials

555 60th of 2000 higher than 1,941 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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Source: ClinicalTrials.gov NCT00081588, the US trial registry maintained by the National Library of Medicine. NCT00081588 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.