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Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00056641
First received: March 19, 2003
Last updated: November 13, 2013
Last verified: November 2013
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 Patients. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) [ Time Frame: Day 14 to Day 28 ]
- Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs [ Time Frame: week 4 ]
Secondary Outcome Measures:
- Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) [ Time Frame: Week 1 and 2 ]
- Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) [ Time Frame: Week 3 and 4 ]
- Assessment of patient adherence [ Time Frame: Week 1 to 4 ]
- Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) [ Time Frame: week 2 and 4 ]
- Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 [ Time Frame: week 4 ]
- Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 [ Time Frame: week 4 ]
- AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV [ Time Frame: week 2 and 4 ]
- Change in viral load; Proportion of virologic responders [ Time Frame: week 2, 4, 8, 16 and 24 ]
| Estimated Enrollment: | 328 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00056641
Show 109 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056641
Show 109 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim |
More Information
| ClinicalTrials.gov Identifier: | NCT00056641 History of Changes |
| Other Study ID Numbers: |
1182.51 |
| Study First Received: | March 19, 2003 |
| Last Updated: | November 13, 2013 |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Saquinavir Lopinavir Amprenavir Tipranavir |
Protease Inhibitors HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 23, 2017