Darunavir (DRV)

DRUG5 trials

Sponsors

Tibotec Pharmaceuticals, Ireland, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, ViiV Healthcare, Janssen Scientific Affairs, LLC

Conditions

HIV InfectionsHealthyHuman Immunodeficiency Virus - Type 1Infection, Human Immunodeficiency Virus

Phase 1

TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

CompletedNCT01308658

Tibotec Pharmaceuticals, IrelandHealthy

Start: 2011-01-31End: 2011-05-31Updated: 2014-02-06

DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

CompletedNCT02063360

ViiV HealthcareInfection, Human Immunodeficiency Virus

Start: 2014-02-01End: 2014-05-13Updated: 2017-08-08

Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

CompletedNCT02984852

Janssen Scientific Affairs, LLCHealthy

Start: 2016-12-31End: 2017-02-28Updated: 2025-02-03

Phase 3

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

CompletedNCT00524368

Tibotec Pharmaceuticals, IrelandHuman Immunodeficiency Virus - Type 1

Start: 2007-10-31End: 2011-10-31Updated: 2013-02-15

Unknown Phase

IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

CompletedNCT00977756

International Maternal Pediatric Adolescent AIDS Clinical Trials GroupHIV Infections

Start: 2002-08-31End: 2014-03-31Updated: 2015-08-07

Related Papers

Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants.

2022-03-228 citations

HIV-1 resistance rarely observed in patients using darunavir once-daily regimens across clinical studies.

2017-11-1632 citations

Bioavailability and bioequivalence of a darunavir 800-mg tablet formulation compared with the 400-mg tablet formulation.

2014-09-015 citations