Ritonavir

Generic Name: Ritonavir

Brand Names: Kaletra, Norvir, Paxlovid, Viekira Pak, Ritonavir Mylan

Drug Type: Small Molecule

Chemical Formula: C_₃₇H_₄₈N_₆O_₅S_₂

CAS Number: 155213-67-5

Unique Ingredient Identifier: O3J8G9O825

Background: Ritonavir is an HIV protease inhibitor that interferes with the reproductive cycle of HIV. Although it was initially developed as an independent antiviral agent, it has been shown to possess advantageous properties in combination regimens with low-dose ritonavir and other protease inhibitors. It is now more commonly used as a booster of other protease inhibi...

Indication: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
...

Associated Conditions: Chronic hepatitis C genotype 1a, Chronic hepatitis C genotype 1b, Human Immunodeficiency Virus Type 1 (HIV-1) Infection, Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)

Associated Therapies: -

Clinical Trials

Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 BS
Other: Grapefruit juice
Drug: Nelfinavir
Drug: Atazanavir
Drug: Ritonavir

First Posted Date: 2014-10-06

Last Posted Date: 2014-10-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 44

Registration Number: NCT02257008

Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 BS
Drug: Combivir®
Drug: Ritonavir

First Posted Date: 2014-10-06

Last Posted Date: 2014-10-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 51

Registration Number: NCT02256774

Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir
Drug: Ritonavir
Drug: Atazanavir

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 21

Registration Number: NCT02253836

Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 - D1
Drug: BILR 355 - D2
Drug: BILR 355 - D3
Drug: BILR 355 - D4
Drug: Ritonavir
Other: high fat breakfast

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 48

Registration Number: NCT02253927

Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 BS, D8
Drug: BILR 355 BS, D5
Drug: BILR 355 BS, D7
Drug: BILR 355 BS, D1
Drug: BILR 355 BS, D3
Drug: BILR 355 BS, D4
Drug: BILR 355 BS, D6
Drug: BILR 355 BS, D2
Drug: Placebo
Drug: BILR 355 BS, D10
Drug: Ritonavir
Other: high-fat breakfast

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 62

Registration Number: NCT02253953

Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: 14C-Tipranavir
Drug: Tipranavir
Drug: Ritonavir

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Registration Number: NCT02253797

Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: BILR 355 BS, solution
Drug: BILR 355 BS, tablet
Drug: Ritonavir

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 100

Registration Number: NCT02253914

Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 BS
Drug: Ritonavir
Drug: TRUVADA

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 33

Registration Number: NCT02253901

Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BILR 355 - Treatment D (current tablet formulation)
Drug: BILR 355 - Treatment A (current tablet formulation)
Drug: BILR 355 - Treatment B (new tablet formulation)
Drug: BILR 355 - Treatment E (new capsule formulation)
Drug: BILR 355 - Treatment C (new capsule formulation)
Drug: Ritonavir

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 40

Registration Number: NCT02253940

Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Carbamazepine
Drug: Tipranavir
Drug: Ritonavir

First Posted Date: 2014-10-01

Last Posted Date: 2014-10-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 28

Registration Number: NCT02253849

Drug Development Updates

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