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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144170 |
The objective of this study is to demonstrate the safety and efficacy of TPV/RTV versus an active control arm in highly treatment experienced HIV-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring PI-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tipranavir (with low dose ritonavir) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 882 |
Study Start Date: | February 2003 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening genotypic resistance report indicating both of the following:
At least 3 consecutive months experience taking ARVs from each of the classes of NRTI(s), NNRTI(s) , and PIs at some point in treatment history,
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
Exclusion Criteria:
Female patients of child-bearing potential who:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1182.48, RESIST 2 |
Study First Received: | September 2, 2005 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00144170 |
Health Authority: | Austria: Bundesministerium fuer soziale Sicherheit und Generationen; Belgium: Federal Agency for Medicines and Health Products; Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica; Switzerland: Swissmedic; Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano; Portugal: INFARMED I.P.; United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Tipranavir |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |