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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00517192 |
The objective of this study is to compare the efficacy and safety of TPV/r (500mg/200mg BID) to the safety and efficacy of DRV/r (600 mg /100 mg BID) in combination with investigator selected optimised background regimens in patients who are three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tipranavir Drug: Darunavir Drug: Ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Open-Labelled, Multi-Centre Trial Comparing the Safety and Efficacy of Ritonavir-Boosted Aptivus (Tipranavir, TPV/r) to That of Prezista? (Darunavir, DRV/r) in Three-Class (NRTI, NNRTI, and PI) Treatment-Experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients |
Estimated Enrollment: | 800 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2009 (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:
9. Acceptable screening laboratory values that indicate adequate baseline organ function.
Exclusion Criteria:
Female patient of child-bearing potential who:
has a positive serum pregnancy test at screening or during the study, is breast feeding, is planning to become pregnant, is not willing to use barrier methods of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1182.71 |
Study First Received: | August 15, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00517192 |
Health Authority: | United States: Food and Drug Administration Argentina: Italy: Comitato Etico Azienda Spedali Civili di Brescia France: AFSSAPS Poland: Romania: Austria: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Wars |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Darunavir 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 |