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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 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 115 participants.
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.
Interventions
- DRUG TPV oral solution
- DRUG RTV oral solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2003-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00076999
The ClinicalTrials.gov registry entry for NCT00076999 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TPV oral solution is the first listed.
NCT00076999 reports 0 study locations.
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.
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