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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00056641 |
Purpose
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.
The primary objective is to determine the safety and pharmacokinetics of:
TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: tipranavir Drug: ritonavir Drug: saquinavir Drug: amprenavir Drug: lopinavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | An Open Label, Randomised, Parallel Group Pharmacokinetics Trial of TPV/RTV Alone or in Combination With RTV-Boosted SQV, APV or LPV, Plus an OBR in Multiple ARV Experienced Patients. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Show 109 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 1182.51 |
| Study First Received: | March 19, 2003 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00056641 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Infection Tipranavir Anti-Bacterial Agents Amprenavir Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |