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.
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- 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
- -
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
- Conditions
- Interventions
- First Posted Date
- 2009-10-12
- Last Posted Date
- 2014-09-05
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 25
- Registration Number
- NCT00993148
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸Quest Clinical Research, San Francisco, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers
- First Posted Date
- 2009-07-10
- Last Posted Date
- 2017-07-02
- Target Recruit Count
- 53
- Registration Number
- NCT00936793
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
- First Posted Date
- 2009-06-12
- Last Posted Date
- 2014-04-23
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Target Recruit Count
- 27
- Registration Number
- NCT00919854
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
- Conditions
- Interventions
- First Posted Date
- 2009-06-08
- Last Posted Date
- 2012-09-03
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Target Recruit Count
- 12
- Registration Number
- NCT00915655
GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir
- Conditions
- Interventions
- First Posted Date
- 2009-03-23
- Last Posted Date
- 2012-02-22
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 17
- Registration Number
- NCT00867152
- Locations
- 🇺🇸
GSK Investigational Site, Buffalo, New York, United States
A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
- Conditions
- Interventions
- First Posted Date
- 2009-03-04
- Last Posted Date
- 2018-07-06
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- Target Recruit Count
- 77
- Registration Number
- NCT00855335
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
- Conditions
- Interventions
- First Posted Date
- 2009-03-04
- Last Posted Date
- 2011-05-13
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Target Recruit Count
- 13
- Registration Number
- NCT00855088
- Locations
- 🇺🇸
UNC Hospitals CTRC, Chapel Hill, North Carolina, United States
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
- Conditions
- Interventions
- First Posted Date
- 2009-03-04
- Last Posted Date
- 2017-10-17
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Target Recruit Count
- 15
- Registration Number
- NCT00855413
- Locations
- 🇺🇸
The University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸Duke University, Durham, North Carolina, United States
Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
- Conditions
- Interventions
- First Posted Date
- 2009-02-26
- Last Posted Date
- 2016-01-13
- Target Recruit Count
- 334
- Registration Number
- NCT00851799
- Locations
- 🇺🇸
Harbor - UCLA Med. Ctr. CRS, Torrance, California, United States
🇺🇸Northwestern University CRS (2701), Chicago, Illinois, United States
🇺🇸Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States
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.
- First Posted Date
- 2009-02-23
- Last Posted Date
- 2014-01-22
- 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
Drug Development Updates
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