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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00447902 |
The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or HBV co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.
Condition | Intervention | Phase |
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HIV Infections |
Drug: tipranavir Drug: ritonavir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Antiviral Activity of TPV in Hepatitis C or Hepatitis B HIV co-Infected Patients - TDM Randomized Pilot Evaluation |
Enrollment: | 11 |
Study Start Date: | March 2007 |
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:
Exclusion Criteria:
Female patients of childbearing potential who:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1182.99, EudraCT No.: 2005-005023-33 |
Study First Received: | March 14, 2007 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00447902 |
Health Authority: | United States: Food and Drug Administration; Brazil: Agência Nacional de Vigilância Sanitária - ANVISA; France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS); Italy: Comitato Etico Locale per la Sperimentazione Clinica Osp. L. Sacco - Milano; Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento; Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología) |
treatment experienced |
Virus Diseases Hepatitis Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Hepatitis B Hepatitis C Retroviridae Infections Immunologic Deficiency Syndromes Tipranavir |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Anti-Retroviral Agents Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |