Tipranavir

Generic Name: Tipranavir

Brand Names: Aptivus

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₃F_₃N_₂O_₅S

CAS Number: 174484-41-4

Unique Ingredient Identifier: ZZT404XD09

Background: Tipranavir is a sulfonamide-containing dyhydropyrone and a nonpeptidic protease inhibitor that targets the HIV protease. Tipranavir and ritonavir are coadministered to treat HIV.

Indication: For combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.

Associated Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir
Drug: Ritonavir

First Posted Date: 2014-09-19

Last Posted Date: 2014-09-19

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 32

Registration Number: NCT02244190

Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir solution
Drug: Tipranavir capsule
Drug: Ritonavir capsule
Drug: Caffeine
Drug: Warfarin sodium
Drug: Vitamin K
Drug: Omeprazole
Drug: Dextromethorphan hydrobromide
Drug: Midazolam injection
Drug: Midazolam oral solution
Drug: Digoxin tablet
Drug: Digoxin injection

First Posted Date: 2014-09-18

Last Posted Date: 2014-09-18

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 34

Registration Number: NCT02243553

Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients

Phase 2

Terminated

Conditions: HIV Infections

Interventions: Drug: Tipranavir (TPV) low dose
Drug: Tipranavir (TPV) high dose
Drug: Ritonavir high dose
Drug: Ritonavir low dose
Drug: Saquinavir

First Posted Date: 2014-09-15

Last Posted Date: 2014-09-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 79

Registration Number: NCT02239835

Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: Tipranavir low dose
Drug: Tipranavir high dose
Drug: Ritonavir
Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Drug: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)

First Posted Date: 2014-09-12

Last Posted Date: 2014-09-12

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 41

Registration Number: NCT02238314

Effect of Steady State TPV/r on Intracellular Concentrations of Zidovudine and Carbovir for Patients With HIV

Phase 1

Terminated

Conditions: HIV Infections

Interventions: Drug: Tipranavir capsules
Drug: Ritonavir capsules

First Posted Date: 2014-09-01

Last Posted Date: 2014-09-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 3

Registration Number: NCT02229760

Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir
Drug: Ritonavir
Drug: Valaciclovir

First Posted Date: 2014-08-27

Last Posted Date: 2014-08-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 29

Registration Number: NCT02226978

Effects of Steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir Concentration at Steady-state in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir
Drug: Ritonavir
Drug: Efavirenz

First Posted Date: 2014-08-27

Last Posted Date: 2014-08-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 34

Registration Number: NCT02226991

Effects of Single-dose and Steady-state TPV/RTV on the Steady-state Pharmacokinetics of Fluconazole in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir (TPV)
Drug: Ritonavir (RTV)
Drug: Fluconazole (FCZ)

First Posted Date: 2014-07-21

Last Posted Date: 2014-07-21

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 20

Registration Number: NCT02195466

A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

Completed

Conditions: HIV Infections

Interventions: Drug: Tipranavir
Drug: ritonavir

First Posted Date: 2009-09-15

Last Posted Date: 2014-03-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 42

Registration Number: NCT00976950

Locations: 🇷🇴
Boehringer Ingelheim Investigational site 17, Brasov, Romania
🇷🇴
Boehringer Ingelheim Investigational site 2, Bucuresti, Romania
🇷🇴
Boehringer Ingelheim Investigational site 20, Tg.Mures, Romania

and more 17 locations

An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Conditions: HIV Infections

First Posted Date: 2009-07-07

Last Posted Date: 2016-11-30

Lead Sponsor: Boehringer Ingelheim

Registration Number: NCT00933205

Locations: 🇧🇪
1182.16.3202 Boehringer Ingelheim Investigational Site, Antwerpen, Belgium
🇧🇪
1182.16.3203 Boehringer Ingelheim Investigational Site, Brussel, Belgium
🇧🇪
1182.16.3204 Boehringer Ingelheim Investigational Site, Gent, Belgium

and more 212 locations

Drug Development Updates

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