30 completed, 8 recruiting, 7 unknown, 2 active not recruiting. 13 Phase 3, 11 Phase 1, 11 Phase 2, 11 Phase 4, 1 Early Phase 1.
Follow doravirine: new trials by email Literature Review of doravirine trials Research Report on doravirine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIV Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg, Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg - HIV (Human Immunodeficiency Virus), Sleep | Phase 4 | Not yet recruiting | University of Witwatersrand, South Africa | 40 | 2026-10-05 | 2026-10-06 |
| Efficacy and Safety of Doravirine in the Rapid Initiation Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet - HIV-1-infection | Phase 4 | Recruiting | Fundación Huésped | 100 | 2026-09-16 | 2026-09-23 |
| Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully Doravirine 100Mg Tab and Lamivudine 300 Mg Tab, Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab - HIV-1-infection | Phase 2 | Recruiting | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | 408 | 2025-04-30 | 2025-06-11 |
| DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection Doravirine + tenofovir DF + lamivudine, Dolutegravir + tenofovir DF + lamivudine or emtricitabine - HIV-1-infection | Phase 3 | Recruiting | ANRS, Emerging Infectious Diseases | 610 | 2025-01-27 | 2026-07-27 |
| Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI Integrase inhibitor, Doravirine + tenofovir DF + lamivudine - HIV, HIV Associate Weight Loss | Phase 4 | Unknown | Instituto Mexicano del Seguro Social | 108 | 2024-08-14 | 2024-09-19 |
| Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV Doravirine 100 Mg - HIV I Infection, Cardiovascular Risk Factor | Early Phase 1 | Completed | University of Texas Southwestern Medical Center | 26 | 2024-03-01 | 2026-01-30 |
| DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road) Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] - Hiv | Phase 2 | Recruiting | University Hospital, Caen | 32 | 2024-02-08 | 2025-07-24 |
| A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055) MK-8591A, Islatravir, Doravine - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2024-01-23 | 2024-12-06 |
| B-free Multistage Trial DOR/DTG/3TC - HIV, Drug Resistance | Phase 4 | Enrolling by invitation | Insel Gruppe AG, University Hospital Bern | 210 | 2023-11-13 | 2024-12-04 |
| Doravirine Dose Optimisation in Pregnancy Doravirine, Dolutegravir - HIV | Phase 4 | Recruiting | University of Liverpool | 76 | 2023-10-10 | 2026-02-19 |
| "Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk" Doravirine - HIV Infections | Completed | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | 226 | 2023-06-08 | 2024-10-08 | |
| A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) DOR/ISL - HIV Infection | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 641 | 2023-03-17 | 2025-12-17 |
| Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers Doravirine 100Mg Tab, Biktarvy 50/200/25 Tab - Hiv | Phase 4 | Completed | Radboud University Medical Center | 20 | 2023-03-01 | 2026-04-16 |
| A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF - HIV-1 Infection | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 514 | 2023-02-17 | 2025-11-18 |
| Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance Doravirine 100Mg Tab - HIV-1-infection | Phase 4 | Unknown | Fundacion Clinic per a la Recerca Biomédica | 12 | 2022-12-12 | 2023-09-21 |
| Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch Doravirine, Dolutegravir, Triple cART regimen - HIV-1-infection | Phase 3 | Recruiting | Chelsea and Westminster NHS Foundation Trust | 150 | 2022-08-17 | 2023-10-25 |
| Doravirine and Weight Gain in Antiretroviral Naive DOR/3TC/TDF, DOR + FTC/TAF, BIC/FTC/TAF - Body Weight Changes, Human Immunodeficiency Virus | Phase 3 | Withdrawn | Prism Health North Texas | 2022-08-01 | 2023-05-12 | |
| Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women Doravirine - HIV Infections, Pregnancy Related | Phase 1 | Completed | University of North Carolina, Chapel Hill | 7 | 2022-06-09 | 2026-04-16 |
| HIV A6 Genome In ART Unsuccessful Patients On DOR Doravirine - Virus-HIV | Unknown | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | 60 | 2022-05-01 | 2022-04-11 | |
| Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, Estradiol 2mg - Transgender Health, Gender Dysphoria | Phase 1 | Completed | Thomas Jefferson University | 8 | 2022-01-04 | 2025-03-26 |
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Acquired Immunodeficiency Syndrome (12) · HIV Infections (9) · Body Weight Changes (2) · Obesity (2) · Renal Insufficiency (2) · Weight Gain (2) · Cardiovascular Diseases (1) · Fasting (1) · Gender Dysphoria (1) · Inflammation (1) · Kidney Failure, Chronic (1) · Latent Tuberculosis (1) · Lipid Metabolism Disorders (1) · Metabolic Syndrome (1) · Osteoporosis (1)
Merck Sharp & Dohme LLC (19) · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (3) · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida (2) · Chelsea and Westminster NHS Foundation Trust (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Professor Francois Venter (2) · ANRS, Emerging Infectious Diseases (1) · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (1) · Clinique du Quartier Latin (1) · Fundacion Clinic per a la Recerca Biomédica (1) · Fundación Huésped (1) · Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation (1) · Insel Gruppe AG, University Hospital Bern (1) · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (1) · Instituto Mexicano del Seguro Social (1)
United States (17) · South Africa (10) · France (8) · Spain (6) · United Kingdom (6) · Chile (5) · Thailand (5) · Canada (4) · Colombia (4) · Italy (4) · Japan (4) · Russia (4) · Argentina (3) · Australia (3) · Israel (3)
Walter K Kraft, MD (2) · Alain Makinson, Pr (1) · Angela Colbers, PhD (1) · Angela Kashuba, PharmD (1) · Ann Melvin, MD, MPH (1) · Christine Katlama, MD (1) · Daniel Podzamczer Palter, PhD Chief (1) · Daniel Podzamczer, PhD Chief (1) · Francois WD Venter, PhD (1) · Gilles Wandeler, Prof (1) · John Koethe (1) · Karine Lacombe, Pr (1) · Kristine Erlandson, MD (1)
PMID 31121013, PMID 40672760, PMID 41280318, PMID 31121015, PMID 38141637, PMID 39748155, PMID 41081774, PMID 42213454, PMID 42281892, PMID 22903393, PMID 27751765, PMID 28026013, PMID 29592840, PMID 29891610, PMID 30184165, PMID 30985556, PMID 31120195, PMID 31355775, PMID 31425317, PMID 31740348, PMID 32868326, PMID 33336698, PMID 33587439, PMID 33633036, PMID 34000227, PMID 35425985, PMID 35972855, PMID 38421210, PMID 39578038, PMID 39813286, PMID 40079835, PMID 41037024, PMID 41644158, PMID 41654375, PMID 41847923, PMID 42429665
2019 (5), 2014 (3), 2015 (3), 2018 (2), 2017 (1), UM1AI068636 (1)