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CLINICAL TRIALS PROFILE FOR TIPRANAVIR
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505(b)(2) Clinical Trials for Tipranavir
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT02244190 | Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers | Completed | Boehringer Ingelheim | Phase 1 | 2008-04-01 | To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Tipranavir
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00034866 | Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals | Completed | Boehringer Ingelheim | Phase 2 | 2002-04-01 | 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 | 2002-08-01 | 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 | 2002-08-01 | 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 | 2002-08-01 | 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 | 2003-01-01 | 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 | 2003-01-01 | 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). |
| NCT00062660 | Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection | Approved for marketing | Boehringer Ingelheim | N/A | 2003-05-01 | To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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