Darunavir

Generic Name: Darunavir

Brand Names: Prezcobix, Prezista, Rezolsta, Darunavir Viatris (previously Darunavir Mylan), Darunavir Krka

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₃₇N_₃O_₇S

CAS Number: 206361-99-1

Unique Ingredient Identifier: YO603Y8113

Background: Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006.

Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection. Clinical trials are underway and are expected to conclude in August 2020.

Indication: Darunavir, co-administered with ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection.

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

Associated Therapies: -

Clinical Trials

Evaluation of Low-dose Darunavir in a Switch Study

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Darunavir
Drug: Lopinavir

First Posted Date: 2016-02-02

Last Posted Date: 2018-06-26

Lead Sponsor: Willem Daniel Francois Venter

Target Recruit Count: 300

Registration Number: NCT02671383

Locations: 🇿🇦
Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, Gauteng, South Africa

A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide fixed-dose combination (FDC)
Drug: Emtricitabine/tenofovir alafenamide FDC
Drug: Darunavir
Drug: Cobicistat

First Posted Date: 2015-10-19

Last Posted Date: 2017-04-04

Lead Sponsor: Janssen Sciences Ireland UC

Target Recruit Count: 126

Registration Number: NCT02578550

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

Phase 4

Terminated

Conditions: AIDS-related Dementia Complex

Interventions: Drug: Darunavir
Drug: ritonavir
Drug: cobicistat

First Posted Date: 2015-07-21

Last Posted Date: 2017-02-02

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 7

Registration Number: NCT02503462

Locations: 🇨🇭
Division of Infectious Diseases, University Hospital Basel, Basel, BS, Switzerland

Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

Phase 1

Completed

Conditions: HIV-infection

Interventions: Drug: VM-1500
Drug: Darunavir
Drug: Raltegravir
Drug: Ritonavir

First Posted Date: 2015-07-03

Last Posted Date: 2018-10-04

Lead Sponsor: Viriom

Target Recruit Count: 24

Registration Number: NCT02489487

Locations: 🇹🇭
Faculty of Medicine, Siriraj Hospital, Bangkok, Wanglang Road, Thailand

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Phase 1

Completed

Conditions: Acute HIV Infection

Interventions: Drug: Vorinostat
Drug: Hydroxychloroquine
Drug: Maraviroc
Drug: Tenofovir
Drug: Emtricitabine
Drug: Efavirenz
Drug: Darunavir

First Posted Date: 2015-06-19

Last Posted Date: 2023-06-22

Lead Sponsor: SEARCH Research Foundation

Target Recruit Count: 15

Registration Number: NCT02475915

Locations: 🇹🇭
SEARCH, the Thai Red Cross AIDS Research Centre, Bangkok, Thailand

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC
Drug: Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC
Other: High-fat Breakfast
Drug: Darunavir
Drug: Emtricitabine/Tenofovir alafenamide (FTC/TAF)
Drug: Cobicistat
Other: Standardized Regular Breakfast

First Posted Date: 2015-06-18

Last Posted Date: 2017-10-17

Lead Sponsor: Janssen Sciences Ireland UC

Target Recruit Count: 72

Registration Number: NCT02475135

Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Phase 4

Conditions: Patient Compliance
Antiretroviral Therapy Intolerance

Interventions: Drug: elvitegravir/cobicistat/emtricitabine/tenofovir
Drug: Darunavir
Drug: abacavir/lamivudine
Drug: Ritonavir
Drug: rilpivirine
Drug: Lamivudine