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CLINICAL TRIALS PROFILE FOR TIPRANAVIR

Clinical Trials for Tipranavir

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00034866	Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals	Completed	Boehringer Ingelheim	Phase 2	The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
NCT00039741	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00054717	Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)	Completed	Boehringer Ingelheim	Phase 3	Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
NCT00056641	Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients	Completed	Boehringer Ingelheim	Phase 2	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).
Trial ID	Title	Status	Sponsor	Phase	Summary