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
- -
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
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
- Conditions
- Hepatitis C
- Interventions
- First Posted Date
- 2014-06-09
- Last Posted Date
- 2015-11-30
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 49
- Registration Number
- NCT02159352
- Locations
- 🇺🇸
Healthcare Discoveries, Llc D/B/A Icon Development Solutions, San Antonio, Texas, United States
Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS
- Conditions
- HIV/AIDS
- Interventions
- Drug: ART with 2 NRTIs plus LPV/r (or ATV/r)Drug: Darunavir
- First Posted Date
- 2014-06-04
- Last Posted Date
- 2019-09-04
- Lead Sponsor
- University of Liverpool
- Target Recruit Count
- 120
- Registration Number
- NCT02155101
- Locations
- 🇨🇲
Yaounde Central Hospital, Yaounde, Centre, Cameroon
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
- Conditions
- HIV Infections
- Interventions
- First Posted Date
- 2014-04-17
- Last Posted Date
- 2019-04-08
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 11
- Registration Number
- NCT02116660
Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts
- Conditions
- HIV-1 InfectionImmunosuppression-related Infectious Disease
- Interventions
- First Posted Date
- 2013-08-26
- Last Posted Date
- 2018-01-12
- Lead Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Target Recruit Count
- 120
- Registration Number
- NCT01928407
- Locations
- 🇫🇷
Hopital Saint Antoine, Paris, France
🇫🇷Hopital Le Bocage, Dijon, France
🇫🇷C.H.D de Vendee, La Roche Sur Yon, France
A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants
- First Posted Date
- 2013-03-14
- Last Posted Date
- 2013-04-10
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 8
- Registration Number
- NCT01810887
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
- Conditions
- HIVHyperlipidemia
- Interventions
- First Posted Date
- 2012-09-28
- Last Posted Date
- 2020-08-11
- Lead Sponsor
- NYU Langone Health
- Target Recruit Count
- 34
- Registration Number
- NCT01695954
- Locations
- 🇺🇸
Bellevue/NYU AIDS Clinical Trials Unit, New York, New York, United States
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
- Conditions
- HIV-1 Infection
- Interventions
- Drug: Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs)Drug: Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & availableDrug: DarunavirDrug: Emtricitabine/tenofovir disoproxil fumarateOther: SOC adherence versus SOC+CPI adherenceDrug: EtravirineDrug: Raltegravir
- First Posted Date
- 2012-07-16
- Last Posted Date
- 2019-03-15
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Target Recruit Count
- 545
- Registration Number
- NCT01641367
- Locations
- 🇧🇷
Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre, RS, Brazil
🇧🇷Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil
🇮🇳Chennai Antiviral Research and Treatment (CART) CRS (11701), Chennai, Taramani, India
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
- 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
Drug Development Updates
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