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

HIV Infections Clinical Trial

Official title:

Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275444
• Other study ID #: 1182.52
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2002

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. primary completion date: January 20, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Signed informed consent prior to trial participation.

• Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.

• At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).

• Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.

• HIV-1 viral load =1000 copies/mL at screening.

• Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.

• Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".

• Acceptable screening laboratory values that indicate adequate baseline organ function.

• Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).

• Further inclusion criteria apply.

Exclusion criteria:

• ARV medication naïve.

• Only one or no available ARV medications as determined by genotypic resistance testing.

• Female subjects who:

• have a positive serum pregnancy test at screening or during the study;

• are breast feeding;

• are planning to become pregnant;

• are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).

• Any active opportunistic infection within 60 days before study entry.

• Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade 1.

• Prior tipranavir use.

• Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.

• Use of concomitant drugs which may significantly reduce plasma levels of the study medications.

• Further exclusion criteria apply.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tipranavir

Locations

Country	Name	City	State
Australia	Boehringer Ingelheim Investigational Site	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Canada	Montreal Chest Institute - McGill University Health Centre	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
France	Hôpital de Bicêtre	Le Kremlin Bicêtre cedex
France	Hôpital de Chauliac	Montpellier cedex 5
France	Hôpital Hôtel Dieu	Nantes cedex 1
France	Hôpital Saint Louis	Paris cedex 10
France	Hôpital de la pitié Salpetrière	Paris cedex 13
France	Hôpital Bichat Claude Bernard	Paris cedex 18
Germany	Epimed GmbH	Berlin
Germany	Klinikum der J.-W.-Goethe-Universität	Frankfurt/Main
Germany	Klinik I für Innere Medizin der	Köln
Germany	Medizinische Poliklinik	München
Italy	Fondazione Centro S. Raffaele del Monte Tabor	Milano
Italy	IRCCS Policlinico San Matteo	Pavia
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Erasmus Medical Centre	Rotterdam
Spain	Hospital Clínico y Provincial de Barcelona - HIV	Barcelona
Spain	Boehringer Ingelheim Investigational Site	Madrid
Spain	Hospital La Paz.	Madrid
Spain	Hospital Ramón y Cajal.	Madrid
United Kingdom	4th Floor Research Office (St Stephens Centre)	London
United States	Albany Medical College	Albany	New York
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Boehringer Ingelheim Investigational Site	Annandale	Virginia
United States	Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	John's Hopkins University	Baltimore	Maryland
United States	Boehringer Ingelheim Investigational Site	Boston	Massachusetts
United States	CORE Center	Chicago	Illinois
United States	Rush-Presbytarian-St Luke's Medical Center	Chicago	Illinois
United States	Boehringer Ingelheim Investigational Site	Columbia	South Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Boehringer Ingelheim Investigational Site	Fountain Valley	California
United States	ID Care	Hillsborough	New Jersey
United States	Boehringer Ingelheim Investigational Site	Houston	Texas
United States	Boehringer Ingelheim Investigational Site	Huntersville	North Carolina
United States	Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	Boehringer Ingelheim Investigational Site	Las Vegas	Nevada
United States	Living Hope Clinical Trials, Inc.	Long Beach	California
United States	Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Mercer University School of Medicine	Macon	Georgia
United States	1501 N.W. 9th Ave	Miami	Florida
United States	HIV Outpatient Program (H.O.P)	New Orleans	Louisiana
United States	Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri
United States	Boehringer Ingelheim Investigational Site	Santa Fe	New Mexico
United States	Boehringer Ingelheim Investigational Site	South Miami	Florida
United States	Community Research Initiative of New England	Springfield	Massachusetts
United States	University of New York at Stony Brook	Stony Brook	New York
United States	Hillsborough County Health Dept.	Tampa	Florida
United States	Boehringer Ingelheim Investigational Site	Vero Beach	Florida
United States	Vincent Lombardi Cancer Center	Washington	District of Columbia
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response after 2 weeks of functional monotherapy		At week 2
Secondary	Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.		Up to 24 weeks