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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00056641
The ClinicalTrials.gov registry entry for NCT00056641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (26% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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