Tipranavir
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | APTIVUS | — | 2007-10-04 – 2008-06-23 | fda.gov ↗ |
| Approved | EU (EMA) | Aptivus | — | 2005-10-25 | europa.eu ↗ |
| Approved | US (FDA) | APTIVUS | — | 2005-06-22 | fda.gov ↗ |
Trials 56
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 131 trials | ||||||
| Phase 1 | NCT01068925 | Feb → Apr 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02251795 | Aug 2007 → Jun 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00344123 | Feb 2007 → May 2008 | HIV infectious disease | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT02226978 | Feb → May 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02226991 | Apr → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02227017 | Feb → Apr 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02259855 | Jan 2006 → Oct 2008 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02243553 | Jan → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02248883 | Dec 2005 → Mar 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02253862 | Dec 2005 → Mar 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02253849 | Nov 2005 → Jun 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02253875 | Nov 2005 → Feb 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02257021 | Feb → May 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02253836 | Jan → Jul 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02245451 | Jan → Feb 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00307502 | Jan 2005 → Dec 2009 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00076999 | Nov 2003 → Jun 2010 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02249442 | Oct 2003 → Jun 2004 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251158 | Oct → Dec 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251171 | Aug → Oct 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251769 | Aug → Sep 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02253797 | Jul 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02245269 | Jul → Oct 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02195466 | Jun → Jul 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251119 | Jul 2002 → Jan 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251145 | May → Jun 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02245438 | May → Jun 2002 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02253823 | Dec 2001 → Mar 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02249416 | Nov 2001 → Feb 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251873 | Sep 2001 → Mar 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02251132 | Oct → Dec 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02229760 | Aug 2006 → Sep 2007 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1/2 | NCT02251223 | Feb 2001 → Feb 2002 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT00530920 | Oct 2007 → May 2008 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00144105 | Feb 2004 → Nov 2006 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT00056641 | Feb 2003 → Jan 2004 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00034866 | Apr → Oct 2002 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00275444 | Mar 2002 → Jan 2003 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02239835 | Dec 1999 → Nov 2001 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT02249130 | Mar 1999 → Apr 2000 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02238314 | Jan 1999 → Aug 2001 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT00624195 | Mar 2007 → Feb 2012 | HIV infectious disease | University of California, San Diego | Completed | Missed primary |
| Phase 2/3 | NCT00146328 | Apr 2001 → May 2008 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT00537394 | Jan 2008 → May 2012 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT00517192 | Sep 2007 → Sep 2008 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT00447902 | Mar 2007 → Oct 2008 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT00440271 | Feb 2007 → Oct 2008 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT00144287 | May 2004 → Apr 2006 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00144170 | Feb 2003 → Oct 2008 | HIV infectious disease | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00054717 | Jan 2003 → Sep 2008 | HIV infectious disease | Boehringer Ingelheim | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT00607958 | Dec 2007 → May 2009 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00192660 | Feb 2003 → Oct 2006 | cardiovascular disorder, lipodystrophy | Kirby Institute | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00486330 | May 2006 → May 2007 | HIV infectious disease | Yale University | Completed | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT00097799 | Dec 2004 → Aug 2005 | HIV infectious disease | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT00933205 | May 2004 → Jun 2008 | HIV infectious disease | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT00062660 | May 2003 → Apr 2014 | HIV infectious disease | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2/3 | NCT01923311 Background | Aug 2013 → Nov 2017 | AIDS | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT00708162 Background | Jul 2008 → Dec 2010 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tipranavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗58“An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules)...” NCT02251873 ↗ “Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗ “Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers” NCT02227017 ↗ “The purpose of this study is to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).” NCT01068925 ↗ “To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir” NCT02248883 ↗ “The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir” NCT00708162 ↗ “500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID” NCT00144105 ↗ “tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg)” NCT02253823 ↗ “tipranavir (TPV) and ritonavir (RTV)” NCT02251132 ↗ “Tipranavir oral solution” NCT00076999 ↗ |
| Known as | Aptivus | “multiple oral doses of tipranavir (Aptivus) and ritonavir” NCT00146328 ↗ |
| Known as | PNU-140690E | ChEMBL registry synonym — accepted as the source's own label CHEMBL222559 ↗ |
| Known as | TIPRANAVIR DISODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL222559 ↗ |
| Known as | Tipranavir sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL222559 ↗ |
| Known as | tipranavir/r | “Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r.” NCT01923311 ↗ |
| Known as | TPV | “Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers” NCT02227017 ↗23“The purpose of this study is to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).” NCT01068925 ↗ “To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir” NCT02248883 ↗ “Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients.” NCT00344123 ↗ “Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers” NCT02251145 ↗ “Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers” NCT02226978 ↗ “optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients” NCT00530920 ↗ “concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI)” NCT02251873 ↗ “A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV).” NCT00275444 ↗ “Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir (RTV)” NCT02245438 ↗ “two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r)” NCT02239835 ↗ |
| Known as | U-140690 | ChEMBL registry synonym — accepted as the source's own label CHEMBL222559 ↗ |
| Action | Inhibit | “Tipranavir is an investigational protease inhibitor” NCT00034866 ↗ |
| Modality | Small molecule | “novel non-peptidic protease inhibitor tipranavir” PMID 16890833 ↗ Aug 2006 |
| Route | Oral | “TPV and RTV oral solution” NCT00076999 ↗ |