Tipranavir

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment	2014/10/09	NCT02259855	Phase 1	Completed	Boehringer Ingelheim
Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers	2014/10/06	NCT02257021	Phase 1	Completed	Boehringer Ingelheim
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers	2014/10/01	NCT02253849	Phase 1	Completed	Boehringer Ingelheim
Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers	2014/10/01	NCT02253875	Phase 1	Completed	Boehringer Ingelheim
Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers	2014/10/01	NCT02253862	Phase 1	Completed	Boehringer Ingelheim
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir	2014/10/01	NCT02253836	Phase 1	Completed	Boehringer Ingelheim
Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects	2014/10/01	NCT02253797	Phase 1	Completed	Boehringer Ingelheim
Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects	2014/09/29	NCT02251795	Phase 1	Completed	Boehringer Ingelheim
Effects of Steady-state TPV/RTV on the Single-dose Pharmacokinetics of Rifabutin and the Effects of Single-dose Rifabutin on the Steady-state Pharmacokinetics of TPV in Healthy Adult Volunteers	2014/09/29	NCT02251171	Phase 1	Completed	Boehringer Ingelheim
Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir	2014/09/29	NCT02251769	Phase 1	Completed	Boehringer Ingelheim

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Aptivus	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0003	ORAL	250 mg in 1 1	6/18/2025
Aptivus	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0002	ORAL	100 mg in 1 mL	6/29/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Aptivus	Boehringer Ingelheim International GmbH,Binger Strasse 173,55216 Ingelheim am Rhein,Germany	Authorised	10/25/2005

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APTIVUS	boehringer ingelheim (canada) ltd ltee	02273322	Capsule - Oral	250 MG	12/1/2005

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
APTIVUS 250 MG CAPSULAS BLANDAS	Boehringer Ingelheim International Gmbh	05315001	CÁPSULA BLANDA	Uso Hospitalario	Not Commercialized
APTIVUS 100 MG/ML SOLUCION ORAL	Boehringer Ingelheim International Gmbh	05315002	SOLUCIÓN ORAL	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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