Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Public ClinicalTrials.gov record NCT00076999. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00076999
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 115 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2003
- Primary completion
- May 31, 2010
- Completion
- Not listed
- Last update posted
- May 11, 2014
Started 2003
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1182.14.00001 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1182.14.00006 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1182.14.00010 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | — | — |
| 1182.14.00004 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1182.14.00008 Boehringer Ingelheim Investigational Site | North Worcester | Massachusetts | — | — |
| 1182.14.00009 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1182.14.00002 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | — | — |
| 1182.14.00007 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | — | — |
| 1182.14.00003 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00076999, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00076999 live on ClinicalTrials.gov.