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Darunavir

Generic Name
Darunavir
Brand Names
Prezcobix, Prezista, Rezolsta, Darunavir Viatris (previously Darunavir Mylan), Darunavir Krka
Drug Type
Small Molecule
Chemical Formula
C27H37N3O7S
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
Related News

Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

Phase 3
Completed
Conditions
HIV-1 Infection
HIV Infections
Interventions
Drug: darunavir
First Posted Date
2009-02-23
Last Posted Date
2014-01-22
Lead Sponsor
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Target Recruit Count
100
Registration Number
NCT00849160
Locations
🇫🇷

Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales, Paris, France

🇫🇷

Hôpital Tenon - Service des Maladies Infectieuses et Tropicales, Paris, France

🇫🇷

Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales, Le Kremlin Bicêtre, France

and more 2 locations

Comparative Study of Three NNRTI-Sparing HAART Regimens

Phase 3
Completed
Conditions
HIV Infection
Interventions
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Raltegravir
Drug: Darunavir
Drug: Atazanavir
First Posted Date
2008-12-19
Last Posted Date
2014-09-05
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
1814
Registration Number
NCT00811954
Locations
🇺🇸

The Ponce de Leon Center CRS, Atlanta, Georgia, United States

🇺🇸

The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States

🇺🇸

Trinity Health and Wellness Center, Dallas, Texas, United States

and more 54 locations

A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

First Posted Date
2008-10-31
Last Posted Date
2009-06-02
Lead Sponsor
Pfizer
Target Recruit Count
37
Registration Number
NCT00783484
Locations
🇧🇪

Pfizer Investigational Site, Bruxelles, Belgium

NNRTI/PI Toxicity Switch to Darunavir Study

Phase 4
Terminated
Conditions
HIV
Interventions
Drug: darunavir
Drug: ritonavir
First Posted Date
2008-10-02
Last Posted Date
2010-11-01
Lead Sponsor
St Stephens Aids Trust
Target Recruit Count
12
Registration Number
NCT00765154
Locations
🇬🇧

Chelsea and Westminster Hospital, London, United Kingdom

Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

First Posted Date
2008-09-23
Last Posted Date
2015-12-30
Lead Sponsor
Tibotec, Inc
Target Recruit Count
68
Registration Number
NCT00757783

TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

Phase 1
Completed
Conditions
Pharmacokinetics
First Posted Date
2008-09-15
Last Posted Date
2011-06-09
Lead Sponsor
Tibotec Pharmaceuticals, Ireland
Target Recruit Count
23
Registration Number
NCT00752310

TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.

Phase 1
Completed
Conditions
HIV
AIDS
First Posted Date
2008-09-01
Last Posted Date
2011-06-09
Lead Sponsor
Tibotec Pharmaceuticals, Ireland
Target Recruit Count
21
Registration Number
NCT00744887

Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

Phase 4
Completed
Conditions
HIV Infections
Interventions
Drug: Raltegravir
Drug: Darunavir
Drug: Tenofovir/Emtricitabine
Drug: Ritonavir
First Posted Date
2008-05-14
Last Posted Date
2014-09-08
Lead Sponsor
Dallas VA Medical Center
Target Recruit Count
85
Registration Number
NCT00677300
Locations
🇺🇸

Dallas VA Medical Center, Dallas, Texas, United States

🇺🇸

Parkland Health & Hospital System, Dallas, Texas, United States

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Phase 4
Completed
Conditions
Hyperlipidemia
HIV Infections
Interventions
Drug: Pravastatin
Drug: Darunavir
Drug: Ritonavir
Other: Washout
First Posted Date
2008-03-07
Last Posted Date
2014-05-22
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
32
Registration Number
NCT00630734
Locations
🇺🇸

University of Colorado Denver, Aurora, Colorado, United States

Characterization of Acute and Recent HIV-1 Infections in Zurich.

Not Applicable
Recruiting
Conditions
HIV Infections
Interventions
Drug: Dolutegravir
Drug: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate
Drug: Raltegravir
Drug: Darunavir
Drug: Ritonavir
Drug: Rilpivirine
Drug: Lamivudine
Drug: tenofovir
Drug: Emtricitabine
Drug: Abacavir
First Posted Date
2007-10-02
Last Posted Date
2024-12-17
Lead Sponsor
University of Zurich
Target Recruit Count
800
Registration Number
NCT00537966
Locations
🇨🇭

University of Zurich, Zurich, Switzerland

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