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3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00275444
Lead Sponsor
Boehringer Ingelheim
Brief Summary

A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
216
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Virologic response after 2 weeks of functional monotherapyAt week 2
Secondary Outcome Measures
NameTimeMethod
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.Up to 24 weeks

Trial Locations

Locations (44)

Boehringer Ingelheim Investigational Site

🇪🇸

Madrid, Spain

Living Hope Clinical Trials, Inc.

🇺🇸

Long Beach, California, United States

David Geffen School of Medicine at UCLA

🇺🇸

Los Angeles, California, United States

Vincent Lombardi Cancer Center

🇺🇸

Washington, District of Columbia, United States

Therafirst Medical Center

🇺🇸

Fort Lauderdale, Florida, United States

1501 N.W. 9th Ave

🇺🇸

Miami, Florida, United States

Hillsborough County Health Dept.

🇺🇸

Tampa, Florida, United States

Atlanta VA Medical Center

🇺🇸

Decatur, Georgia, United States

Mercer University School of Medicine

🇺🇸

Macon, Georgia, United States

CORE Center

🇺🇸

Chicago, Illinois, United States

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Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain

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