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NCT00056641 · ClinicalTrials.gov registry record · Phase 2
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
A Phase 2 study of HIV Infections, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT00056641: Completed Phase 2 study of HIV Infections, sponsored by Boehringer Ingelheim.
NCT00056641 is a Phase 2 study of HIV Infections that has completed, run by Boehringer Ingelheim. The registered enrollment target is 328 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056641, a Phase 2 study of HIV Infections, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
Conditions Studied
Interventions
- DRUG ritonavir
- DRUG tipranavir
- DRUG saquinavir
- DRUG amprenavir
- DRUG lopinavir
Study Locations (20)
Florida
- North Broward Hospital District - Fort Lauderdale
- Boehringer Ingelheim Investigational Site - Fort Myers
- Boehringer Ingelheim Investigational Site - Miami
- Boehringer Ingelheim Investigational Site - Orlando
- Boehringer Ingelheim Investigational Site - Sarasota
- Boehringer Ingelheim Investigational Site - Tampa
- Boehringer Ingelheim Investigational Site - Vero Beach
California
- Boehringer Ingelheim Investigational Site - Berkeley
- Boehringer Ingelheim Investigational Site - Fountain Valley
- Boehringer Ingelheim Investigational Site - Los Angeles
- Boehringer Ingelheim Investigational Site - San Francisco
- Kaiser Permanente Medical Center - San Francisco
- San Francisco VAMC - San Francisco
Georgia
- Boehringer Ingelheim Investigational Site - Atlanta
- Mercer University School of Medicine - Macon
Arizona
- Boehringer Ingelheim Investigational Site - Phoenix
Connecticut
- Boehringer Ingelheim Investigational Site - Norwalk
District of Columbia
- Washington DC VA Medical Center - Washington D.C.
Kentucky
- University of Kentucky Medical Center - Lexington
Massachusetts
- Boehringer Ingelheim Investigational Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2003-02-18 |
| Phase | Phase 2 |
What the finished NCT00056641 record still lists
NCT00056641 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (26% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which ritonavir is the first listed.
NCT00056641 names 20 study sites across 8 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00056641 about?
NCT00056641 is a clinical study titled "Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients". This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patient...
What is the current status of trial NCT00056641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 328 participants. The study started on 2003-02-18.
What conditions does trial NCT00056641 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00056641?
The interventions under investigation include: ritonavir (DRUG), tipranavir (DRUG), saquinavir (DRUG), amprenavir (DRUG), lopinavir (DRUG).
Who is sponsoring clinical trial NCT00056641?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00056641 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00056641's enrollment target sits among peer trials
328 107th of 542 higher than 436 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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