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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00440271 |
Purpose
The primary purpose of this study is to:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: tipranavir Drug: ritonavir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care |
| Enrollment: | 33 |
| Study Start Date: | February 2007 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main inclusion criteria for the study are:
Exclusion Criteria:
Main exclusion criteria for the study are:
Contacts and Locations
Show 31 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1182.98, EudraCT No.: 2005-005264-86 |
| Study First Received: | February 26, 2007 |
| Last Updated: | February 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00440271 History of Changes |
| Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología); Brazil: ANVISA; Canada: Therapeutic Products Directorate; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) - Milano; United States: Food and Drug Administration |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Tipranavir Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |