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

Clinical Trials

A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: darunavir
Drug: cobicistat

First Posted Date: 2012-06-14

Last Posted Date: 2013-03-04

Lead Sponsor: Janssen R&D Ireland

Target Recruit Count: 133

Registration Number: NCT01619527

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients

Completed

Conditions: Human Immunodeficiency Virus (HIV)

Interventions: Drug: darunavir (PREZISTA)
Drug: etravirine (INTELENCE)
Drug: Other antiretroviral medications
Drug: ritonavir

First Posted Date: 2012-06-08

Last Posted Date: 2014-05-22

Lead Sponsor: Janssen Inc.

Target Recruit Count: 77

Registration Number: NCT01615601

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

Phase 3

Withdrawn

Conditions: HIV

Interventions: Drug: Darunavir
Drug: Atazanavir
Drug: Ritonavir
Drug: Optimized NRTI backbone

First Posted Date: 2012-05-24

Last Posted Date: 2023-12-19

Lead Sponsor: Bristol-Myers Squibb

Registration Number: NCT01605084

Locations: 🇺🇸
Anthony M. Mills Md Inc, Los Angeles, California, United States
🇺🇸
Metropolis Medical Pc, San Francisco, California, United States
🇺🇸
Be Well Medical Center, Berkley, Michigan, United States

and more 9 locations

A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: danoprevir
Drug: darunavir
Drug: ritonavir

First Posted Date: 2012-01-26

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 40

Registration Number: NCT01519336

Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects

Phase 3

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: dolutegravir 50 mg OAD
Drug: darunavir 800mg OAD
Drug: ritonavir 100mg OAD

First Posted Date: 2011-10-10

Last Posted Date: 2018-01-16

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 488

Registration Number: NCT01449929

Locations: 🇨🇭
GSK Investigational Site, Zurich, Switzerland

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

Phase 3

Completed

Conditions: Acquired Immunodeficiency Syndrome (AIDS) Virus
Human Immunodeficiency Virus (HIV) Infections

Interventions: Drug: Darunavir
Drug: Ritonavir

First Posted Date: 2011-10-07

Last Posted Date: 2017-11-27

Lead Sponsor: Janssen-Cilag International NV

Target Recruit Count: 274

Registration Number: NCT01448707

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: Emtricitabine
Drug: Tenofovir disoproxil fumarate
Drug: Placebo for Tenofovir disoproxil fumarate
Drug: Placebo for Maraviroc
Drug: Maraviroc

First Posted Date: 2011-07-22

Last Posted Date: 2024-10-11

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 262

Registration Number: NCT01400412

Locations: 🇺🇸
University of Colorado Hospital CRS (6101), Aurora, Colorado, United States
🇺🇸
Univ. of South Florida (USF) College of Medicine ATN CRS (33001), Tampa, Florida, United States
🇺🇸
Washington U CRS (2101), Saint Louis, Missouri, United States

and more 35 locations