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NCT00146328 · ClinicalTrials.gov registry record · Phase 2

Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
997
Enrollment target

NCT00146328: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT00146328 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 997 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (650% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00146328, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
997 participants
Enrollment target

Study Summary

The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.

Primary Outcome

NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.

Interventions

  • DRUG Tipranavir

Trial Details

FieldValue
Enrollment Target 997 participants
Start Date 2001-04
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT00146328 record still lists

NCT00146328 is an interventional study that assigns participants to a tested intervention. The registered 997 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 (650% higher).

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

NCT00146328 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00146328 about?

NCT00146328 is a clinical study titled "Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects". The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications...

What is the current status of trial NCT00146328?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 997 participants. The study started on 2001-04.

What interventions are being tested in trial NCT00146328?

The interventions under investigation include: Tipranavir (DRUG).

Who is sponsoring clinical trial NCT00146328?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00146328's enrollment target sits among peer trials

997 26th of 2000 higher than 1,975 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 NCT00146328, the US trial registry maintained by the National Library of Medicine. NCT00146328 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.