Darunavir

Overview

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

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers	2009/07/10	NCT00936793	Phase 1	Completed	National Institutes of Health Clinical Center (CC)
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children	2009/06/12	NCT00919854	Phase 2	Completed	Tibotec Pharmaceuticals, Ireland
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents	2009/06/08	NCT00915655	Phase 2	Completed	Tibotec Pharmaceuticals, Ireland
GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir	2009/03/23	NCT00867152	Phase 1	Completed	ViiV Healthcare
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	2009/03/04	NCT00855335	Phase 3	Completed	Janssen Scientific Affairs, LLC
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue	2009/03/04	NCT00855088	Phase 1	Completed	University of North Carolina, Chapel Hill
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine	2009/03/04	NCT00855413	Phase 4	Terminated	University of North Carolina, Chapel Hill
Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters	2009/02/26	NCT00851799	N/A	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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.	2009/02/23	NCT00849160	Phase 3	Completed	Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Comparative Study of Three NNRTI-Sparing HAART Regimens	2008/12/19	NCT00811954	Phase 3	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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