| Pifeltro (doravirine) / Merck (MSD) |
2020-004454-30: Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease Extracción de doravirina por la hemodiálisis en pacientes VIH con insuficiencia renal crónica terminal. |
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| Not yet recruiting | 4 | 8 | Europe | Film-coated tablet, Pifeltro | Fundació FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència, Fundació FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència, Study Program Initiated by Merck Sharp & Dohme Corp Researcher | Patients with HIV and end stage renal disease (ESRD) undergoing on intermittent hemodialysis Pacientes con VIH y insuficiencia renal crónica terminal sometidos a sesiones intermitentes de hemodiálisis, Patients with HIV and end stage renal disease undergoing on intermittent hemodialysis Pacientes con VIH y insuficiencia renal crónica terminal sometidos a hemodiálisis, Diseases [C] - Virus Diseases [C02] | | | | |
NCT04334551: HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance |
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| Recruiting | 4 | 40 | Canada, RoW | Doravirine | Clinique du Quartier Latin, Merck Frosst Canada Ltd. | HIV Infections | 07/22 | 10/22 | | |
2020-000205-89: Changes in weight, body composition and metabolic parameters in HIV infected patients after switch from 2- to 3-drug treatment |
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| Not yet recruiting | 4 | 126 | Europe | Tablet, Viread, Delstrigo, Dovato, Tenofovir disproxil "Sandoz", Tenofovir disproxil "Stada", Tenofovir disproxil "TEVA", Tenofovir disproxil "Accordpharma", Tenofovir disproxil "Glenmark", Tenofovir disproxil "Orion", Tenofovir disproxil "Accord" | Department of Infectious Diseases, Hvidovre Hospital, The Simonsen Foundation | Human immunodeficiency virus (HIV) Human immundefekt virus (HIV), Human immunodeficiency virus (HIV) Human immundefekt virus (HIV), Diseases [C] - Virus Diseases [C02] | | | | |
2022-001591-33: Pilot Study of a Switch strategy from Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance Estudio piloto de una estrategia de cambio de etravirina (ETR) a doravirina (DOR) en adultos infectados por VIH-1 virológicamente suprimidos con resistencia a ETR |
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| Not yet recruiting | 4 | 25 | Europe | Capsule, PIFELTRO | Fundació Clinic per a la Recerca Biomèdica, MSD | Human Immunodeficiency Virus (HIV) Virus de Inmunodeficiencia Humana (VIH), Human Immunodeficiency Virus (HIV) Virus de Inmunodeficiencia Humana (VIH), Diseases [C] - Virus Diseases [C02] | | | | |
EPIC, NCT04669678: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa |
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| Completed | 4 | 108 | RoW | Etonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA), Sub-cutaneous medroxyprogesterone acetate (SC MPA), Non-hormonal intrauterine device (IUD) | University of Alabama at Birmingham, Merck Sharp & Dohme LLC, Wits Reproductive Health and HIV Institute, University of Washington | HIV Infections, Contraception, Drug-drug Interaction | 02/24 | 02/24 | | |
| Recruiting | 4 | 76 | RoW | Doravirine, Delstrigo, Dolutegravir, TLD | University of Liverpool, Liverpool School of Tropical Medicine, Desmond Tutu Health Foundation | HIV | 11/25 | 02/26 | | |
| Terminated | 4 | 18 | Europe | DELSTRIGO 100Mg-300Mg-300Mg Tablet | Chelsea and Westminster NHS Foundation Trust, Merck Sharp & Dohme LLC | Hiv | 11/24 | 11/24 | | |
NCT04636437: Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide |
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| Active, not recruiting | 4 | 222 | US | Doravirine 100 Mg, Tenofovir alafenamide/emtricitabine, tenofovir alafenamide/lamivudine, Integrase strand transfer inhibitors, tenofovir disproxil fumarate/emtricitabine, tenofovir disproxil fumarate/lamivudine | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Institute of Allergy and Infectious Diseases (NIAID) | HIV Infections | 11/24 | 11/24 | | |
| Recruiting | 4 | 36 | Europe | Doravirine 100Mg Tab, pifeltro, Raltegravir 600Mg Tab, issentres, Biktarvy 50/200/25 Tab, biktarvy | Radboud University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Merck Sharp & Dohme LLC | Hiv | 11/24 | 12/24 | | |
NCT05506605: Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance |
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| Active, not recruiting | 4 | 12 | Europe | Doravirine 100Mg Tab | Fundacion Clinic per a la Recerca Biomédica | HIV-1-infection | 12/24 | 12/24 | | |
| Enrolling by invitation | 4 | 210 | Europe | DOR/DTG/3TC, Doravirine (Pifeltro®) + Dolutegravir/Lamivudine (Dovato®) | Insel Gruppe AG, University Hospital Bern, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern | HIV, Drug Resistance, Drug Drug Interaction | 10/26 | 09/27 | | |
2021-000243-50: Understanding the Impact of HIV-DNA resistance mutations detected by NGS in Simplificationstrategies to 2-Drug Regimens for patients virologically suppressed with previous failures and/orprevious resistance mutations: a prospective multi-centre intervention study (INS-2DR) Impatto delle mutazioni di resistenza rilevate su HIV-DNA con NGS nelle strategie di Semplificazione a regimi a due farmaci in pazienti HIV+ virologicamente soppressi con pregressi fallimenti virologici e/o pregresse mutazioni di resistenza: uno studio prospettico interventistico multi-centrico (INS-2DR) |
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| Not yet recruiting | 3 | 210 | Europe | Lamivudina, Pifeltro, Emtriva, Juluca, Janssen-Cilag International NV, Tivicay, Dovato, [-], Tablet, Film-coated tablet, Capsule, hard, Coated tablet, Lamivudina, Pifeltro, Emtriva, Juluca, EDURANT, Tivicay, Dovato | ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", Ministero della salute | HIV infection Infezione da HIV, HIV infection Infezione da HIV, Diseases [C] - Virus Diseases [C02] | | | | |
| Completed | 3 | 769 | NA | Doravirine, Darunavir, Ritonavir, TRUVADA™ or EPZICOM™/KIVEXA™ | Merck Sharp & Dohme LLC | HIV-1 | 09/16 | 03/23 | | |
2018-003915-24: Doravirine concentrations and antiviral activity in Cerebrospinal fluid in HIV-1 Infected individuals Concentraciones de doravirina y actividad antiviral en líquido cefalorraquídeo en individuos infectados por VIH-1 |
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| Not yet recruiting | 3 | 15 | Europe | Doravirine, MK-1439, Film-coated tablet | Fundacio Lluita contra la SIDA, Lluita contra la SIDA Foundation in collaboration with MERCK Sharp & Dome | HIV infected individuals Individuos infectados por el VIH, HIV infected individuals Individuos infectados por el VIH, Diseases [C] - Virus Diseases [C02] | | | | |
ELDORADO, NCT06203132: DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection |
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| Not yet recruiting | 3 | 610 | Europe, RoW | Doravirine + tenofovir DF + lamivudine, Delstrigo, Dolutegravir + tenofovir DF + lamivudine or emtricitabine | ANRS, Emerging Infectious Diseases, MSD France | HIV-1-infection | 11/26 | 11/27 | | |
DORDOL, NCT04892654: Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch |
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| Recruiting | 3 | 150 | Europe | Doravirine, Pifeltro, Dolutegravir, Tivicay, Triple cART regimen | Chelsea and Westminster NHS Foundation Trust | HIV-1-infection | 11/26 | 11/27 | | |
2018-003921-27: Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals. Concentraciones de doravirina y actividad antiviral en fluidos genitales en individuos infectados con VIH-1. |
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| Not yet recruiting | 2 | 30 | Europe | DORAVIRINE, MK-1439, Film-coated tablet | Lluita contra la SIDA Foundation, Lluita contra la SIDA Foundation in collaboration with Merck Sharp & DOme | HIV infected individuals Individuos infectados por VIH, HIV infected individuals Individuos infectados por VIH, Diseases [C] - Virus Diseases [C02] | | | | |
2019-004195-19: A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen |
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| Not yet recruiting | 2 | 150 | Europe | Isentress, Pifeltro, J05AX08, J05AR24, Tablet, ISENTRESS, Pifeltro | Centre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida (CREPATS), Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS), CREPATS, Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS) | HIV disease, HIV disease, Diseases [C] - Virus Diseases [C02] | | | | |
DORAL, NCT04513626: HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label |
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| Recruiting | 2 | 150 | Europe | DORAVIRINE 100 MG [Pifeltro], Raltegravir 600 Mg x 2 [Isentress] | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | HIV Infections | 10/25 | 10/25 | | |
MODULO, NCT06774872: Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully |
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| Not yet recruiting | 2 | 408 | NA | Doravirine 100Mg Tab and Lamivudine 300 Mg Tab, Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida, Organization providing support funding (ANRS-MIE), Organization providing support methodology coordination (IPLESP) | HIV-1-infection | 01/27 | 06/28 | | |
| Recruiting | 2 | 84 | US, RoW | Doravirine, MK-1439, 2 NRTIs | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus (HIV) Infection | 03/28 | 04/34 | | |
NCT04900974: Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women |
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| Recruiting | 1 | 10 | US | Doravirine | University of North Carolina, Chapel Hill, Merck Sharp & Dohme LLC | HIV Infections, Pregnancy Related | 03/25 | 07/25 | | |
NCT04820933: Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV |
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| Recruiting | 1 | 20 | US | Doravirine 100 Mg, Descovy (200 mg emtricitabine + 10 mg tenofovir alafenamide fumarate) | University of Texas Southwestern Medical Center, Merck Sharp & Dohme LLC | HIV I Infection, Cardiovascular Risk Factor, Lipid Metabolism Disorders | 09/25 | 09/25 | | |
| Not yet recruiting | N/A | 50 | NA | Phenotypic resistance measure | Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental | HIV-1-infection | 10/21 | 05/22 | | |
NCT04495348: Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance |
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| Completed | N/A | 18 | US | Doravirine | University of Colorado, Denver, Gilead Sciences | HIV-1-infection, Weight Gain | 01/23 | 06/23 | | |
DrEW, NCT05421806: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/ |
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| Completed | N/A | 399 | Europe | | NEAT ID Foundation, Merck Sharp & Dohme LLC | HIV I Infection | 02/23 | 08/23 | | |
LABRADOR, NCT05536466: The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine |
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| Not yet recruiting | N/A | 8 | NA | bariatric surgery | Radboud University Medical Center | HIV Infections, Bariatric Surgery Candidate | 07/23 | 08/23 | | |
SWEED, NCT06155019: Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination |
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| Completed | N/A | 109 | Europe | | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | HIV Infections | 05/24 | 09/24 | | |
DORASPEP, NCT05761509: "Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk" |
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| Completed | N/A | 226 | Europe | Doravirine, Delstrigo®, Pifeltro® | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, Merck Sharp & Dohme LLC | HIV Infections | 06/24 | 06/24 | | |
| Completed | N/A | 22 | Europe | Switch from an INSTI-based regimen to the non INSTI-based regimen combining TDF/3TC/Doravirine | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | HIV Infections | 03/24 | 01/25 | | |
NCT04518228: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum |
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| Recruiting | N/A | 325 | US, RoW | Bictegravir (BIC), Tenofovir alafenamide (TAF), Cabotegravir (CAB), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r), Darunavir/ritonavir (DRV/r), Lopinavir/ritonavir (LPV/r), Cobicistat, Ritonavir, First-Line TB Treatment, Second-Line TB Treatment, Doravirine (DOR) | National Institute of Allergy and Infectious Diseases (NIAID), International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme LLC | HIV Infections, Tuberculosis | 03/26 | 03/26 | | |
DORAge, NCT05202613: Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (). |
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| Recruiting | N/A | 90 | Europe | Doravirine | University of Roma La Sapienza | HIV | 12/22 | 12/22 | | |
| Not yet recruiting | N/A | 60 | NA | Doravirine, DOR | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation, MSD Pharmaceuticals LLC | Virus-HIV | 05/23 | 01/24 | | |
NCT05140603: Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine |
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| Not yet recruiting | N/A | 150 | Europe | | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Hiv | 07/23 | 10/23 | | |
