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
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
- Conditions
- HIV-infection
- Interventions
- 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
Dual Therapy With Boosted Darunavir + Dolutegravir
- Conditions
- HIV-Infection
- Interventions
- First Posted Date
- 2015-07-01
- Last Posted Date
- 2023-11-29
- Lead Sponsor
- Technical University of Munich
- Target Recruit Count
- 269
- Registration Number
- NCT02486133
- Locations
- 🇩🇪
Klinikum rechts der Isar, Munich, Germany
Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection
- Conditions
- Acute HIV Infection
- Interventions
- 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
- Conditions
- Healthy
- Interventions
- Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDCOther: High-fat BreakfastDrug: Emtricitabine/Tenofovir alafenamide (FTC/TAF)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
- Conditions
- Patient ComplianceAntiretroviral Therapy Intolerance
- Interventions
- First Posted Date
- 2015-06-12
- Last Posted Date
- 2016-06-30
- Lead Sponsor
- Juan A. Arnaiz
- Target Recruit Count
- 150
- Registration Number
- NCT02470650
- Locations
- 🇪🇸
Josep Mallolas Masferrer, Barcelona, Spain
HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- First Posted Date
- 2015-05-07
- Last Posted Date
- 2024-01-09
- Target Recruit Count
- 122
- Registration Number
- NCT02437110
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients
- First Posted Date
- 2015-03-10
- Last Posted Date
- 2017-01-24
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- Target Recruit Count
- 100
- Registration Number
- NCT02384967
- Locations
- 🇫🇷
Hôpital Saint Louis, Paris, France
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- First Posted Date
- 2014-10-29
- Last Posted Date
- 2018-01-24
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 32
- Registration Number
- NCT02277600
- Locations
- 🇺🇸
GSK Investigational Site, San Antonio, Texas, United States
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
- Conditions
- HIV-1
- Interventions
- First Posted Date
- 2014-10-27
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 769
- Registration Number
- NCT02275780
Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2014-09-29
- Last Posted Date
- 2014-09-29
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 52
- Registration Number
- NCT02251795
Drug Development Updates
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