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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR APTIVUS

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Clinical Trials for Aptivus

Trial ID Title Status Sponsor Phase Summary
NCT00146328 Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects Completed Boehringer Ingelheim Phase 2/Phase 3 The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.
NCT00344123 Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects Completed Boehringer Ingelheim Phase 1 Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00344123 Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects Completed Johns Hopkins University Phase 1 Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00517192 Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI Terminated Boehringer Ingelheim Phase 3 The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (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.
NCT00531206 Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients. Completed Boehringer Ingelheim N/A This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aptivus

Condition Name

Condition Name for Aptivus
Intervention Trials
HIV Infections 7
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Condition MeSH

Condition MeSH for Aptivus
Intervention Trials
HIV Infections 7
Infection 1
Communicable Diseases 1
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Clinical Trial Locations for Aptivus

Trials by Country

Trials by Country for Aptivus
Location Trials
United States 39
Canada 6
Germany 3
France 3
Spain 2
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Trials by US State

Trials by US State for Aptivus
Location Trials
Maryland 3
California 3
Missouri 2
Florida 2
Texas 2
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Clinical Trial Progress for Aptivus

Clinical Trial Phase

Clinical Trial Phase for Aptivus
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Aptivus
Clinical Trial Phase Trials
Completed 6
Terminated 1
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Clinical Trial Sponsors for Aptivus

Sponsor Name

Sponsor Name for Aptivus
Sponsor Trials
Boehringer Ingelheim 6
National Institutes of Health (NIH) 1
National Institute of Mental Health (NIMH) 1
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Sponsor Type

Sponsor Type for Aptivus
Sponsor Trials
Industry 6
Other 2
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chubb
Boehringer Ingelheim
Baxter
Fish and Richardson
Johnson and Johnson
AstraZeneca
McKinsey
Chinese Patent Office

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