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
- -
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
- Conditions
- HIV Infections
- Interventions
- First Posted Date
- 2007-10-01
- Last Posted Date
- 2021-11-04
- Target Recruit Count
- 517
- Registration Number
- NCT00537394
- Locations
- 🇺🇸
Children's National Med. Ctr. ATN CRS, Washington, District of Columbia, United States
🇺🇸Univ. of Rochester ACTG CRS, Rochester, New York, United States
🇺🇸UCLA CARE Center CRS, Los Angeles, California, United States
Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI
- Conditions
- HIV Infections
- First Posted Date
- 2007-08-16
- Last Posted Date
- 2014-05-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 40
- Registration Number
- NCT00517192
- Locations
- 🇨🇦
1182.71.1002 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
🇧🇸1182.71.1016 Boehringer Ingelheim Investigational Site, Nassau, Bahamas
🇵🇹1182.71.3502 Boehringer Ingelheim Investigational Site, Amadora, Portugal
Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136
- First Posted Date
- 2007-01-12
- Last Posted Date
- 2013-07-18
- Lead Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Target Recruit Count
- 225
- Registration Number
- NCT00421551
- Locations
- 🇫🇷
Service des maladies infectieuses et tropicales Hopital Pitie salpetriere, Paris, France
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
- First Posted Date
- 2006-09-27
- Last Posted Date
- 2014-04-21
- Lead Sponsor
- Tibotec, Inc
- Target Recruit Count
- 429
- Registration Number
- NCT00381303
Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
- Conditions
- HIV Infections
- Interventions
- Drug: EfavirenzDrug: DarunavirDrug: AtazanavirDrug: NevirapineDrug: RitonavirProcedure: Pharmacokinetic StudyDrug: Tenofovir disoproxil fumarate
- First Posted Date
- 2005-12-01
- Last Posted Date
- 2021-11-09
- Target Recruit Count
- 75
- Registration Number
- NCT00260078
- Locations
- 🇺🇸
Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago, Illinois, United States
🇺🇸Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago, Illinois, United States
🇺🇸Children's Hosp. of Boston NICHD CRS, Boston, Massachusetts, United States
Drug Development Updates
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