HIV Infections Clinical Trial
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.
| NCT number | NCT00056641 |
| Other study ID # | 1182.51 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | February 18, 2003 |
| Verified date | November 2023 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 328 |
| Est. completion date | |
| Est. primary completion date | January 27, 2004 |
| 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 type 1 (HIV-1) infected males or females =18 years of age. - Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype. - Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and 90. - At least 3 consecutive months experience taking ARVs from each of the classes of Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in treatment history, with at least 2 PI-based regimens, one of which must be part of the current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at least 3 months prior to randomization. - HIV-1 viral load =1000 copies/mL at screening. - Further inclusion criteria apply. Exclusion criteria: - Anti-retroviral (ARV) medication naïve. - Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months. - Female patients of child-bearing potential 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 a use barrier method of contraception, or - require ethinyl estradiol administration. - Prior tipranavir use. - Use of investigational medications within 30 days before study entry or during the trial. - Further exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Boehringer Ingelheim Investigational Site | Darlinghurst | New South Wales |
| Australia | St. Vincent's Hospital | Darlinghurst | New South Wales |
| Belgium | Instituut Tropische Geneeskunde | Antwerpen | |
| Belgium | Centre Hospitalier Universitaire St. Pierre | Bruxelles | |
| Belgium | U.Z. Gent | Gent | |
| Canada | McMaster University Medical Centre | Hamilton | Ontario |
| Canada | McGill University Health Centre, Suite A5-140 | Monteal | Quebec |
| Canada | Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | Montreal Chest Institute - McGill University Health Centre | Montreal | Quebec |
| Canada | Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | Canadian Immunodeficiency Research Collaborative Inc. | Toronto | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| Denmark | Hvidovre Hospital | Hvidovre | |
| Denmark | Rigshospitalet | København Ø | |
| Denmark | Odense Universitetshospital | Odense C | |
| France | Hôpital Pellegrin | Bordeaux cedex | |
| France | Hôpital Côte de Nacre | Caen | |
| France | Hôpital Antoine Beclère | Clamart | |
| France | Hôpital de l'Hôtel Dieu | Lyon Cedex 2 | |
| France | Hôpital Hôtel Dieu | Nantes | |
| France | Hôpital de l'Archet | Nice cedex 3 | |
| France | Hôpital de la Pité Salpêtrière | Paris | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hôpital Saint Antoine | Paris | |
| France | Hôpital Bichat Claude Bernard | Paris cedex 18 | |
| France | Hôpital de Pontchaillou | Rennes cedex 9 | |
| France | Hôpital civil | Strasbourg | |
| France | Hôpital brabois | Vandoeuvre les nancy | |
| France | Hôpital Paul Brousse | Villejuif | |
| Germany | Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | Epimed GmbH | Berlin | |
| Germany | Universitätsklinikum Charité | Berlin | |
| Germany | Medizinische Universitätsklinik Bonn | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
| Germany | Universitätsklinik Erlangen-Nürnberg | Erlangen | |
| Germany | Universitätsklinikum Essen | Essen | |
| Germany | Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt/Main | |
| Germany | Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | Universitätsklinkum Freiburg | Freiburg | |
| Germany | ifi Institut für interdisziplinäre Infektiologie | Hamburg | |
| Germany | Universitätsklinik Hamburg-Eppendorf | Hamburg | |
| Germany | Med. Hochschule Hannover | Hannover | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Klinik I für Innere Medizin der | Köln | |
| Germany | Facharzt für Innere Medizin, | Mannheim | |
| Germany | Boehringer Ingelheim Investigational Site | München | |
| Germany | Medizinische Poliklinik | München | |
| Germany | Klinium Natruper Holz | Osnabrück | |
| Germany | Boehringer Ingelheim Investigational Site | Stuttgart | |
| Greece | 1st Social Insurance Foundation (IKA) Pentelis | Athens | |
| Greece | Andreas Syggros Hosp. | Athens | |
| Greece | Evangelismos Hospital | Athens | |
| Greece | General Hospital "G. Gennimatas" | Athens | |
| Greece | Korgialenio-Benakio-Hellenic Red Cross General Hospital | Athens | |
| Greece | Sismanoglio Hospital | Athens | |
| Greece | University Hospital of Patras | Patras | |
| Greece | "Tzanio" Hospital | Piraeus | |
| Greece | AHEPA Hospital | Thessaloniki | |
| Italy | Fondazione S. Raffaele del Monte Tabor | Milano | |
| Italy | Ospedale Amedeo di Savoia | Torino | |
| Netherlands | OLVG | Amsterdam | |
| Netherlands | Slotervaart Hospital | Amsterdam | |
| Netherlands | Medical Centre Haaglanden | Den Haag | |
| Netherlands | Erasmus Medical Centre | Rotterdam | |
| Portugal | Hospital Condes Castro Guimarães | Cascais | |
| Portugal | Hospitais da Universidade de Coimbra | Coimbra | |
| Portugal | Department of Infeccious Diseases | Lisbon | |
| Portugal | Hospital de São João | Porto | |
| Switzerland | Universitätsspital Basel | Basel | |
| Switzerland | Kantonsspital St. Gallen | St. Gallen | |
| Switzerland | Universitätsspital Zürich | Zürich | |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | SSAT/Crusaid Institute | London | |
| United Kingdom | St Mary's Hospital | London | |
| United States | Albany Medical College | Albany | New York |
| United States | Boehringer Ingelheim Investigational Site | Annandale | Virginia |
| United States | Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | Boehringer Ingelheim Investigational Site | Berkeley | California |
| United States | Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | UT Southwestern | Dallas | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | North Broward Hospital District | Fort Lauderdale | Florida |
| United States | Boehringer Ingelheim Investigational Site | Fort Myers | Florida |
| United States | Boehringer Ingelheim Investigational Site | Fountain Valley | California |
| United States | Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | Boehringer Ingelheim Investigational Site | Huntersville | North Carolina |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | Mercer University School of Medicine | Macon | Georgia |
| United States | Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | Boehringer Ingelheim Investigational Site | New York | New York |
| United States | Boehringer Ingelheim Investigational Site | Norwalk | Connecticut |
| United States | Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | Kaiser Permanente Medical Center | San Francisco | California |
| United States | San Francisco VAMC | San Francisco | California |
| United States | Boehringer Ingelheim Investigational Site | Santa Fe | New Mexico |
| United States | Boehringer Ingelheim Investigational Site | Sarasota | Florida |
| United States | Boehringer Ingelheim Investigational Site | Springfield | Massachusetts |
| United States | University of New York, Stony Brook | Stony Brook | New York |
| United States | Boehringer Ingelheim Investigational Site | Tacoma | Washington |
| United States | Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | Boehringer Ingelheim Investigational Site | Vero Beach | Florida |
| United States | Washington DC VA Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Australia, Belgium, Canada, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) | Day 14 to Day 28 | ||
| Primary | Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs | week 4 | ||
| Secondary | Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) | Week 1 and 2 | ||
| Secondary | Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) | Week 3 and 4 | ||
| Secondary | Assessment of patient adherence | Week 1 to 4 | ||
| Secondary | Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) | week 2 and 4 | ||
| Secondary | Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 | week 4 | ||
| Secondary | Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 | week 4 | ||
| Secondary | AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV | week 2 and 4 | ||
| Secondary | Change in viral load; Proportion of virologic responders | week 2, 4, 8, 16 and 24 |
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