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Common TitleBI-1182.2 Industry
Official Title Tipranavir Disodium: An Open-Label Exploratory Study of Tipranavir and Ritonavir in Combination With One Nucleoside Reverse Transcriptase Inhibitor and One Non-Nucleoside Reverse Transcriptase Inhibitor in Multiple Protease Inhibitor-Experienced HIV Patients
Phase Phase II
ClinicalTrials.gov NCT02238314
Treatments
Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Treatment-Experienced
Funding
IndustryBoehringer Ingelheim
References
- Markowitz M, Slater LN, Schwartz R, et al. Long-term efficacy and safety of tipranavir boosted with ritonavir in HIV-1-infected patients failing multiple protease inhibitor regimens: 80-week data from a phase 2 study. J Acquir Immune Defic Syndr. 2007;45:401-10.
Official Title A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks
Phase Phase II
ClinicalTrials.gov NCT00144105
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Tipranavir
, Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryBoehringer Ingelheim
References
- Carr A, Ritzhaupt A, Zhang W, et al. Effects of boosted tipranavir and lopinavir on body composition, insulin sensitivity and adipocytokines in antiretroviral-naive adults. AIDS. 2008;22:2313-21.
- Cooper DA, Cordery DV, Zajdenverg R, et al. Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial. PLoS One. 2016;11:e0144917.
Common TitleBI-1182.51 Industry
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
Phase Phase II
ClinicalTrials.gov NCT00056641
Treatments
Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryBoehringer Ingelheim
References
- Walmsley SL, Katlama C, Lazzarin A, et al. Pharmacokinetics, safety, and efficacy of tipranavir boosted with ritonavir alone or in combination with other boosted protease inhibitors as part of optimized combination antiretroviral therapy in highly treatment-experienced patients (BI Study 1182.51). J Acquir Immune Defic Syndr. 2008;47:429-40.
Common TitlePACTG 1051 Industry
Official Title Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
Phase Phase I
ClinicalTrials.gov NCT00076999
Treatments
Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePharmacologyTreatment-ExperiencedAdverse EffectsPediatrics
Funding
IndustryBoehringer Ingelheim
References
- Salazar JC, Cahn P, Della Negra M, et al. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014;33:396-400.
- Salazar JC, Cahn P, Yogev R, et al. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008;22:1789-98.
Official Title A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients
Phase Phase III
ClinicalTrials.gov NCT00517192
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryBoehringer Ingelheim
References
- Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011;11:295-302.
Common TitleRESIST-1 Industry
Official Title Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.
Phase Phase III
ClinicalTrials.gov NCT00054717
Treatments
Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsResistance/Virological Failure
Funding
IndustryBoehringer Ingelheim
References
- Gathe J, Cooper DA, Farthing C, et al. Efficacy of the protease inhibitors tipranavir plus ritonavir in treatment-experienced patients: 24-week analysis from the RESIST-1 trial. Clin Infect Dis. 2006;43:1337-46.
- Hicks CB, Cahn P, Cooper DA, et al. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006;368:466-75.
- Hill A, Moyle G. Relative antiviral efficacy of ritonavir-boosted darunavir and ritonavir-boosted tipranavir vs. control protease inhibitor in the POWER and RESIST trials. HIV Med. 2007;8:259-64.
Common TitleRESIST-2 Industry
Official Title Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)
Phase Phase III
ClinicalTrials.gov NCT00144170
Treatments
Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse EffectsReview
Funding
IndustryBoehringer Ingelheim
References
- Cahn P, Villacian J, Lazzarin A, et al. Ritonavir-boosted tipranavir demonstrates superior efficacy to ritonavir-boosted protease inhibitors in treatment-experienced HIV-infected patients: 24-week results of the RESIST-2 trial. Clin Infect Dis. 2006;43:1347-56.
- Hicks CB, Cahn P, Cooper DA, et al. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006;368:466-75.
- Hill A, Moyle G. Relative antiviral efficacy of ritonavir-boosted darunavir and ritonavir-boosted tipranavir vs. control protease inhibitor in the POWER and RESIST trials. HIV Med. 2007;8:259-64.
- Luna B, Townsend MU. Tipranavir: the first nonpeptidic protease inhibitor for the treatment of protease resistance. Clin Ther. 2007;29:2309-18.
Clinical Trial Image Decks
BI-1182.33 - July 5, 2017
POTENT - May 24, 2017