| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD) |
DORAVIPEP, NCT04233372: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study |
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| Recruiting | 4 | 400 | Europe | Delstrigo | David Garcia Cinca, Dr. Josep Mallolas | Hiv | 02/21 | 03/21 | | |
2021-005347-79: Exposure to Doravirine in people with HIV undergoing weight loss surgery Blootstelling aan doravirine bij mensen met hiv die een operatie voor gewichtsverlies ondergaan |
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| Ongoing | 4 | 8 | Europe | Film-coated tablet, Pifeltro® (100 mg doravirine), Delstrigo® (100 mg doravirine/ 300 mg Lamivudine/ 245 mg Tenofovir Disoproxil Fumarate) | Radboud University Medical Center, Radboud University Medical Center | HIV plus bariatric surgery, HIV and weight loss surgery, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | | | | |
AVERTAS-2, NCT04903847: Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil |
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| Recruiting | 4 | 126 | Europe | Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], Dovato, Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO], Delstrigo | Thomas Benfield | Hiv, HIV Infections, HIV Lipodystrophy, Osteoporosis, Renal Insufficiency, Weight Gain, Obesity | 02/23 | 02/23 | | |
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] | | | | |
| 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 | | |
DeLiTE, NCT04665375: Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? |
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| Terminated | 4 | 4 | Canada | DOR/3TC/TDF, Delstrigo | University Health Network, Toronto, Merck Canada Inc. | Hiv, Weight Gain | 03/24 | 03/24 | | |
| Recruiting | 4 | 108 | RoW | Integrase inhibitor, Doravirine + tenofovir DF + lamivudine | Instituto Mexicano del Seguro Social | HIV, HIV Associate Weight Loss, HIV-1 Infection, Integrase Inhibitors, HIV; HIV PROTEASE INHIB, Weight Change, Weight Loss | 11/25 | 11/25 | | |
DRIVE-AHEAD, NCT02403674 / 2014-003382-17: Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) |
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| Completed | 3 | 734 | NA | Doravirine, Tenofovir, Lamivudine, MK-1439A, ATRIPLA™, Placebo | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus (HIV) | 03/17 | 09/23 | | |
DRIVE-SHIFT, NCT02397096 / 2014-005550-18: Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) |
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| Completed | 3 | 673 | NA | Doravirine, Tenofovir, Lamivudine, Doravirine (PIFELTRO™), Doravirine/Lamivudine/Tenofovir disoproxil fumarate (DELSTRIGO™), MK-1439A, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Baseline regimen of cobicistat-boosted elvitegravir, Baseline regimen of a non-nucleoside reverse transcriptase inhibitor, Baseline regimen of two nucleoside reverse transcriptase inhibitors | Merck Sharp & Dohme LLC | HIV-1 Infection | 02/18 | 09/23 | | |
DORA, NCT04433780: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV |
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| Completed | 3 | 133 | RoW | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, Delstrigo | Professor Francois Venter | HIV-1-infection | 02/23 | 03/23 | | |
| Withdrawn | 3 | 150 | US | DOR/3TC/TDF, Delstrigo, DOR + FTC/TAF, Pifeltro + Descovy, BIC/FTC/TAF, Biktarvy | Prism Health North Texas, Merck Sharp & Dohme LLC | Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting | 05/23 | 05/23 | | |
ADORE, NCT04429152: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance |
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| Recruiting | 3 | 25 | RoW | Doravirine/Lamivudine/Tenofovir, Delstrigo | Professor Francois Venter | HIV-1-infection | 09/23 | 09/23 | | |
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 | | |
Opti-DOR, NCT05924438: A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy |
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| Recruiting | 3 | 600 | RoW | Delstrigo, KOCITAF | Professor Francois Venter, Africa Health Research Institute, Merck Sharp & Dohme LLC | HIV-1-infection | 06/26 | 06/26 | | |
| Completed | 2 | 86 | NA | Doravirine, Tenofovir, Lamivudine - Blinded, MK-1439A, Doravirine, Tenofovir, Lamivudine - Open-Label, ATRIPLA^TM, Placebo to ATRIPLA™, Placebo to Doravirine, Tenofovir, Lamivudine | Merck Sharp & Dohme LLC | HIV-1, Central Nervous System | 08/18 | 02/24 | | |
2017-000437-32: Dose Ranging Trial of MK-8591 Given in Combination with Doravirine (DOR) and Lamivudine (3TC) |
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| Not yet recruiting | 2 | 120 | Europe | MK-8591, Doravirine, Doravirine/Lamivudine/Tenofovir disoproxil fumarate, Epivir, MK-8591A, MK-8591, MK-1439, MK-1439A, MK-8591A, Capsule, Film-coated tablet, Epivir | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | HIV-1 infection, HIV-1 infection, Diseases [C] - Virus Diseases [C02] | | | | |
DOR, NCT06034938: /TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road) |
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| Not yet recruiting | 2 | 32 | Europe | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO], Delstrigo | University Hospital, Caen, Merck Sharp & Dohme LLC | Hiv | 04/24 | 05/25 | | |
| Recruiting | 2 | 84 | US, RoW | Doravirine, MK-1439, 2 NRTIs | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus (HIV) Infection | 03/28 | 04/34 | | |
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 | | |
