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NCT00076999 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
NCT00076999: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT00076999 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076999, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule. The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
Primary Outcome
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Interventions
- DRUG TPV oral solution
- DRUG RTV oral solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2003-11 |
| Phase | Phase 1 |
What the finished NCT00076999 record still lists
NCT00076999 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 2 interventions - of which TPV oral solution is the first listed.
NCT00076999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00076999 about?
NCT00076999 is a clinical study titled "Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children". The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir a...
What is the current status of trial NCT00076999?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2003-11.
What interventions are being tested in trial NCT00076999?
The interventions under investigation include: TPV oral solution (DRUG), RTV oral solution (DRUG).
Who is sponsoring clinical trial NCT00076999?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00076999's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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