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| Tracking Information | |||||
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| First Received Date ICMJE | February 7, 2003 | ||||
| Last Updated Date | November 2, 2009 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
The primary endpoints are the proportion of patients with a treatment response at 48 weeks (>=1 log10 reduction in two consecutive viral load measurements without prior evidence of treatment failure) and the time to treatment failure through 48 weeks. | ||||
| Change History | Complete list of historical versions of study NCT00054717 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Treatment emergent AIDS-defining illnesses reported in the first 48 weeks of study treatment. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. 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 Aug 5;368(9534):466-75. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 630 | ||||
| Completion Date | |||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients meeting the following criteria will be eligible for participation in th is study:
30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90. 3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization. 4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening. Exclusion criteria: Patients with any of the following criteria are excluded from participation in t he study:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada, Puerto Rico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00054717 | ||||
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study ID Numbers ICMJE | 1182.12 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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