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
- -
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
- Conditions
- Interventions
- First Posted Date
- 2012-01-26
- Last Posted Date
- 2016-11-02
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 40
- Registration Number
- NCT01519336
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
- Conditions
- Interventions
- First Posted Date
- 2011-10-07
- Last Posted Date
- 2017-11-27
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 274
- Registration Number
- NCT01448707
Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
- First Posted Date
- 2011-07-22
- Last Posted Date
- 2024-10-11
- Target Recruit Count
- 262
- Registration Number
- NCT01400412
- Locations
- 🇺🇸
University of Colorado Hospital CRS (6101), Aurora, Colorado, United States
🇺🇸Univ. of South Florida (USF) College of Medicine ATN CRS (33001), Tampa, Florida, United States
🇺🇸Washington U CRS (2101), Saint Louis, Missouri, United States
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
- First Posted Date
- 2011-06-16
- Last Posted Date
- 2015-07-31
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 14
- Registration Number
- NCT01374802
- Locations
- 🇩🇪
1220.49.1 Boehringer Ingelheim Investigational Site, Berlin, Germany
The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study
- First Posted Date
- 2011-05-05
- Last Posted Date
- 2019-10-31
- Lead Sponsor
- Imperial College London
- Target Recruit Count
- 13
- Registration Number
- NCT01348763
- Locations
- 🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom
TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)
- Conditions
- Interventions
- First Posted Date
- 2011-03-25
- Last Posted Date
- 2012-10-11
- Lead Sponsor
- Tibotec Pharmaceuticals, Ireland
- Target Recruit Count
- 49
- Registration Number
- NCT01323257
TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV
- First Posted Date
- 2011-01-24
- Last Posted Date
- 2022-10-31
- Lead Sponsor
- Janssen Sciences Ireland UC
- Target Recruit Count
- 145
- Registration Number
- NCT01281813
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
- Conditions
- Interventions
- First Posted Date
- 2010-12-13
- Last Posted Date
- 2019-09-27
- Lead Sponsor
- Hospital Clinic of Barcelona
- Target Recruit Count
- 15
- Registration Number
- NCT01258374
- Locations
- 🇪🇸
Hospital Clinic, Barcelona, Spain
A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
- Conditions
- Interventions
- First Posted Date
- 2010-09-13
- Last Posted Date
- 2013-12-04
- Lead Sponsor
- Tibotec, Inc
- Target Recruit Count
- 54
- Registration Number
- NCT01199939
TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV
- First Posted Date
- 2010-06-07
- Last Posted Date
- 2019-05-01
- Lead Sponsor
- Janssen Sciences Ireland UC
- Target Recruit Count
- 46
- Registration Number
- NCT01138605
Drug Development Updates
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