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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:
Only the four AIDS defining events listed below are acceptable as long as the event has been cured for at least 2 weeks before screening (Visit 1).
Patients with history of other AIDS defining events are not allowed into the trial. The acceptable prior AIDS defining events include: Candidiasis (bronchi, trachea, lungs, esophageal), Herpes simplex: chronic ulcer(s) (more than 1 months duration), bronchitis, pneumonitis, or esophagitis, Mycobacterium tuberculosis (pulmonary or extrapulmonary), Pneumonia including Pneumocystis jiroveci (formerly carinii) pneumonia.
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 History of Changes |
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 |
Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Tipranavir Hepatitis Virus Diseases |
Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Hepatitis B Hepatitis C Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Tipranavir Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |