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Completed Phase 2 Interventional

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

ClinicalTrials.gov ID: NCT00056641

Public ClinicalTrials.gov record NCT00056641. 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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 3:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 Patients.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00056641
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
328 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Feb 18, 2003 (Actual)
Primary completion
Jan 27, 2004 (Actual)
Completion
Not listed
Last update posted
Dec 1, 2023

Started 2003

United States locations

U.S. sites
34
U.S. states
16
U.S. cities
31
Facility City State ZIP Site status
Boehringer Ingelheim Investigational Site Phoenix Arizona — —
Boehringer Ingelheim Investigational Site Berkeley California — —
Boehringer Ingelheim Investigational Site Fountain Valley California — —
Boehringer Ingelheim Investigational Site Los Angeles California — —
Boehringer Ingelheim Investigational Site San Francisco California — —
Kaiser Permanente Medical Center San Francisco California — —
San Francisco VAMC San Francisco California — —
Boehringer Ingelheim Investigational Site Norwalk Connecticut — —
Washington DC VA Medical Center Washington D.C. District of Columbia — —
North Broward Hospital District Fort Lauderdale Florida — —
Boehringer Ingelheim Investigational Site Fort Myers Florida — —
Boehringer Ingelheim Investigational Site Miami Florida — —
Boehringer Ingelheim Investigational Site Orlando Florida — —
Boehringer Ingelheim Investigational Site Sarasota Florida — —
Boehringer Ingelheim Investigational Site Tampa Florida — —
Boehringer Ingelheim Investigational Site Vero Beach Florida — —
Boehringer Ingelheim Investigational Site Atlanta Georgia — —
Mercer University School of Medicine Macon Georgia — —
University of Kentucky Medical Center Lexington Kentucky — —
Boehringer Ingelheim Investigational Site Boston Massachusetts — —
Brigham and Women's Hospital Boston Massachusetts — —
Boehringer Ingelheim Investigational Site Springfield Massachusetts — —
Henry Ford Hospital Detroit Michigan — —
Boehringer Ingelheim Investigational Site Santa Fe New Mexico — —
Albany Medical College Albany New York — —
Boehringer Ingelheim Investigational Site New York New York — —
University of New York, Stony Brook Stony Brook New York — —
Duke University Medical Center Durham North Carolina — —
Boehringer Ingelheim Investigational Site Huntersville North Carolina — —
University of Pennsylvania Philadelphia Pennsylvania — —
UT Southwestern Dallas Texas — —
Boehringer Ingelheim Investigational Site Houston Texas — —
Boehringer Ingelheim Investigational Site Annandale Virginia — —
Boehringer Ingelheim Investigational Site Tacoma Washington — —

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 75 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00056641, 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 Dec 1, 2023 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00056641 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →