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
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2021-01-22
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 22
- Registration Number
- NCT04718805
- Locations
- 🇧🇪
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg), Antwerpen, Belgium
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
- Conditions
- Healthy
- Interventions
- Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
- First Posted Date
- 2020-12-10
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 37
- Registration Number
- NCT04661397
- Locations
- 🇳🇱
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini, Groningen, Netherlands
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
- First Posted Date
- 2020-02-13
- Last Posted Date
- 2024-07-22
- Lead Sponsor
- Geropharm
- Target Recruit Count
- 44
- Registration Number
- NCT04268472
- Locations
- 🇷🇺
Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19
- Conditions
- CoronavirusPneumonia, Pneumocystis
- Interventions
- Drug: Darunavir and Cobicistat
- First Posted Date
- 2020-02-05
- Last Posted Date
- 2020-04-13
- Lead Sponsor
- Shanghai Public Health Clinical Center
- Target Recruit Count
- 30
- Registration Number
- NCT04252274
- Locations
- 🇨🇳
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents
- Conditions
- Healthy
- Interventions
- Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
- First Posted Date
- 2020-01-22
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Target Recruit Count
- 16
- Registration Number
- NCT04236453
- Locations
- 🇳🇱
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini, Groningen, Netherlands
A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2019-12-23
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 28
- Registration Number
- NCT04208061
- Locations
- 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium
Inflammation and Co-Infections in D²EFT
- Conditions
- HIV-infection/AidsHuman Herpesvirus 4 InfectionsCytomegalovirus InfectionsHuman Herpesvirus 8 InfectionHuman Papilloma Virus
- Interventions
- First Posted Date
- 2019-12-03
- Last Posted Date
- 2020-11-10
- Lead Sponsor
- Kirby Institute
- Registration Number
- NCT04183738
Nucleosides And Darunavir/Dolutegravir In Africa
- Conditions
- Human Immunodeficiency Virus
- Interventions
- First Posted Date
- 2019-06-17
- Last Posted Date
- 2020-07-30
- Lead Sponsor
- Makerere University
- Target Recruit Count
- 465
- Registration Number
- NCT03988452
- Locations
- 🇺🇬
Infectious Diseases Institute, Kampala, Uganda
Body Composition Sub-study of the D2EFT Trial
- Conditions
- HIV Infections
- Interventions
- Drug: TDF 300 MG Oral TabletDrug: N(t)RTIsDrug: FTC 200 MG Oral Cap
- First Posted Date
- 2018-09-18
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Kirby Institute
- Target Recruit Count
- 155
- Registration Number
- NCT03675815
- Locations
- 🇿🇦
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, Johannesburg, South Africa
🇿🇦Clinical HIV Research Unit, Helen Joseph Hospital, Westdene, Johannesburg, South Africa
🇿🇦Desmond Tutu HIV Foundation, Cape Town, South Africa
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
- Conditions
- HIVContraception
- Interventions
- First Posted Date
- 2018-07-17
- Last Posted Date
- 2019-03-28
- Lead Sponsor
- Makerere University
- Target Recruit Count
- 60
- Registration Number
- NCT03589040
- Locations
- 🇺🇬
Infectious Diseases Institue, Kampala, Uganda
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.