| islatravir (MK-8591) / Merck (MSD) |
| Terminated | 3 | 730 | US, RoW | Islatravir, MK-8591, Placebo to FTC/TDF, FTC/TDF, TRUVADA™, Emtricitabine/Tenofovir disoproxil, Emtricitabine/Tenofovir disoproxil fumarate, Placebo to ISL | Merck Sharp & Dohme LLC | HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis | 07/23 | 06/24 | | |
| Completed | 3 | 494 | Europe, Japan, US, RoW | ISL, MK-8591, FTC/TDF, Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate, FTC/TAF, Descovy, Emtricitabine/Tenofovir Alafenamide, Placebo to ISL, Placebo to FTC/TDF, Placebo to FTC/TAF | Merck Sharp & Dohme LLC | HIV Preexposure Prophylaxis | 08/23 | 08/23 | | |
ISLEND-2, NCT06630299: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 |
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| Recruiting | 3 | 600 | US | ISL/LEN, Antiretroviral Combinations | Gilead Sciences | HIV-1-Infection | 06/27 | 08/30 | | |
ISLEND-1, NCT06630286: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 |
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| Recruiting | 3 | 600 | US | ISL/LEN, B/F/TAF, Biktarvy®, PTM B/F/TAF, PTM ISL/LEN | Gilead Sciences | HIV-1-infection | 06/26 | 08/30 | | |
NCT04003103: Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016) |
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| Completed | 2a | 242 | US, RoW | Islatravir, MK-8591, Placebo | Merck Sharp & Dohme LLC | HIV-1 Infection | 03/22 | 11/22 | | |
| Not yet recruiting | 2 | 140 | Europe | Islatravir, MK-8507, MK-8591, MK-8507, Capsule, Tablet, Film-coated tablet, Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) | 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] | | | | |
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] | | | | |
MK-8591-013, NCT04564547: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [] |
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| Active, not recruiting | 2 | 161 | Europe, US | Islatravir, MK-8591, Ulonivirine, MK-8507, BIC/FTC/TAF, BIKTARVY®, Placebo to ISL, Placebo to Ulonivirine, Placebo to BIC/FTC/TAF | Merck Sharp & Dohme LLC | HIV-1 Infection | 12/24 | 12/24 | | |
NCT05052996: Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV |
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| Active, not recruiting | 2 | 142 | US | ISL, LEN, GS-6207, B/F/TAF, Biktarvy® | Gilead Sciences, Merck Sharp & Dohme LLC | HIV-1 Infection | 12/23 | 11/27 | | |
MK-8591-043, NCT05115838: Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection |
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| Withdrawn | 2 | 175 | NA | Islatravir, MK-8591, Placebo | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus, HIV | 10/25 | 10/25 | | |
| Completed | 1 | 36 | US | MK-8507, Islatravir, ISL, MK-8591 | Merck Sharp & Dohme LLC | Healthy | 06/24 | 06/24 | | |
| Hengmu (tenofovir amibufenamide) / Jiangsu Hansoh Pharma |
ChiCTR2200064306: Efficacy and safety of long-term treatment with tenofovir amibufenamide in patients aged 65 years and over with chronic hepatitis B |
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| Not yet recruiting | 4 | 200 | | Medical treatment+Oral tenofovir amibufenamide 1 tablet daily | Linyi People's Hospital ; Linyi People's Hospital, self-financing | chronic hepatitis B | | | | |
ChiCTR2300069493: To evaluate the efficacy and safety of Tenofovir Amibufenamide (TMF) in chronic hepatitis B patients with low-level viremia after entecavi treatment |
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| Recruiting | 4 | 204 | | N/A; N/A | The Second Affiliated Hospital of Chongqing Medical University; The Second Affiliated Hospital of Chongqing Medical University, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | chronic hepatitis B | | | | |
ChiCTR2200066338: Observation of the efficacy of tenofovir amibufenamide monotherapy in nucleoside (acid) analogues in naive or treatment-experienced CHB patients |
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| Recruiting | 4 | 600 | | None ;None | The Second Affiliated Hospital of Xi'an Jiaotong University; The Second Affiliated Hospital of Xi'an Jiaotong University, self-raised | Chronic hepatitis B virus infection | | | | |
ChiCTR2400085341: Efficacy and safety of Tenofovir Amibufenamide Tablets in the treatment of patients with chronic hepatitis B—a prospective, multicenter, clinical cohort study |
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| Recruiting | 4 | 132 | | none; none | The First Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Nanchang University, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | chronic hepatitis B | | | | |
ChiCTR2100051284: Long-term safety and efficacy of Tenofovir Amibufenamide in patients with hBeAg-positive or hBeAg-negative chronic hepatitis B: a multicenter, open-label follow-up study |
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| Recruiting | 4 | 1005 | | Amy tenofovir 25mg QD | Nanfang Hospital, Southern Medical University; Nanfang Hospital, Southern Medical University, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | HBeAg-positive or HBBeAg-negative chronic hepatitis B patients | | | | |
NCT03903796: Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection |
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| Active, not recruiting | 3 | 963 | RoW | HS-10234, TDF | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Chronic HBV Infection | 05/20 | 09/23 | | |
NCT05382351: Antiviral Therapy for Patients With Chronic Hepatitis B Infection |
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| Recruiting | 2 | 238 | RoW | Entecavir, Boludine/Rui fu en, Entecavir combined with Tenofovir Amibufenamide, Heng mu | Sun Yat-sen University | Chronic Hepatitis B Virus Infection | 04/24 | 12/24 | | |
ChiCTR-IIR-17011107: A phase 1b randomized, open, positive control clinical trial to evaluate tolerability, pharmacokinetics and pharmacodynamics of muti-dose of HS-10234 in HBV-infected subjects |
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| Recruiting | 1 | 36 | | HS-10234 10 mg ;TDF 300 mg ;HS-10234 25 mg ;TDF 300 mg ;HS-10234 40 mg ;TDF 300 mg | The First Hospital of Jilin University; Shanghai Hansen Biomedical Technology Co., Ltd, secondary sponsor | Chronic hepatitis B | | | | |
| Recruiting | 1 | 20 | | HS-10234 25 mg | The First Affiliated Hospital, Zhejiang University; Shanghai Hansen Biomedical Technology Co., Ltd., Shanghai Hansen Biomedical Technology Co., Ltd. | Viral hepatitis | | | | |
NCT05398393: An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment |
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| Enrolling by invitation | N/A | 150 | RoW | oral Tenofovir Amibufenamide 25mg each day, lipid lowering drugs (e.g. Atorvastatin and amlodipine.) | Wuhan Union Hospital, China | Hepatitis B, Chronic, Lipid Disorder | 06/23 | 06/23 | | |
ChiCTR2300070261: Effectiveness and safety of tenofovir amibufenamide and its comparison with tenofovir alafenamide in patients with chronic hepatitis B: results from a retrospective real-world study |
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| Completed | N/A | 400 | | N/A ;N/A | West China Hospital of Sichuan University; West China Hospital of Sichuan University, None | Chronic viral hepatitis B | | | | |
Promote, NCT05797714: The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. |
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| Active, not recruiting | N/A | 200 | RoW | Tenofovir Amibufenamide（TMF）, HengMu | Ruijin Hospital, Jiangsu Hansoh Pharmaceutical Co., Ltd. | HBV Infection, Chronic Hepatitis b | 06/24 | 04/26 | | |
NCT05755776: The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment |
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| Recruiting | N/A | 204 | RoW | TMF, Heng Mu | The Second Affiliated Hospital of Chongqing Medical University, Jiangsu Hansoh Pharmaceutical Co., Ltd. | Chronic Hepatitis B | 12/24 | 12/24 | | |
ChiCTR2300074529: A real-world study of tenofovir amibufenamide in patients with HBV-associated end-stage liver disease |
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| Recruiting | N/A | 480 | | None; None | The Third Hospital of Hebei Medical University; The Third Hospital of Hebei Medical University, self-financing | HBV-associated end-stage liver disease | | | | |
| MK-8527 / Merck (MSD) |
NCT06045507: Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007) |
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| Active, not recruiting | 2 | 350 | US, RoW | MK-8527, Placebo to MK-8527 | Merck Sharp & Dohme LLC | HIV, HIV Pre-exposure Prophylaxis | 12/24 | 12/24 | | |
| Completed | 1 | 20 | Europe, RoW | MK-8527 | Merck Sharp & Dohme LLC | Human Immunodeficiency Virus | 01/24 | 01/24 | | |
| Recruiting | 1 | 18 | US | MK-8527 | Merck Sharp & Dohme LLC | Renal Impairment | 04/25 | 04/25 | | |
| Not yet recruiting | 1 | 12 | NA | MK-8527 | Merck Sharp & Dohme LLC | Healthy, HIV Pre-exposure Prophylaxis | 12/25 | 12/25 | | |
| doravirine/islatravir (MK-8591A) / Merck (MSD) |
MK-8591A-018, NCT04223791 / 2019-000587-23: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) |
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| Active, not recruiting | 3 | 643 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to FDC DOR/ISL, Placebo to MK-8591A | Merck Sharp & Dohme LLC | HIV Infection | 08/21 | 02/25 | | |
| Completed | 3 | 672 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, ART | Merck Sharp & Dohme LLC | HIV Infection | 09/21 | 08/24 | | |
MK-8591A-020, NCT04233879 / 2019-000590-23: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection |
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| Active, not recruiting | 3 | 599 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, Doravirine/islatravir, BIC/FTC/TAF, Bictegravir/emtricitabine/tenofovir alafenamide, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL | Merck Sharp & Dohme LLC | HIV-1 Infection | 11/22 | 03/25 | | |
| Completed | 3 | 35 | Europe, Canada, Japan, US, RoW | ISL, Islatravir, MK-8591, DOR, Doravirine, MK-1439, DOR/ISL, Doravirine/Islatravir, MK-8591A, Placebo to ISL, Placebo to DOR | Merck Sharp & Dohme LLC | HIV-1 Infection | 11/22 | 11/23 | | |
MK-8591A-051, NCT05631093: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) |
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| Active, not recruiting | 3 | 553 | Europe, Canada, Japan, US, RoW | ART, DOR/ISL, MK-8591A | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/24 | 07/28 | | |
MK-8591A-052, NCT05630755: 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) |
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| Active, not recruiting | 3 | 514 | Europe, Japan, US, RoW | DOR/ISL, MK-8591A, Doravirine/Islatravir, BIC/FTC/TAF, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/24 | 08/28 | | |
| Active, not recruiting | 3 | 2000 | Europe, Canada, Japan, US, RoW | MK-8591A | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/27 | 10/27 | | |
NCT05705349: DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) |
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| Active, not recruiting | 3 | 500 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, BIC/FTC/TAF, Placebo to DOR/ISL, Placebo to BIC/FTC/TAF | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/25 | 08/29 | | |
MK-8591A-054, NCT05766501: 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 |
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| Active, not recruiting | 3 | 650 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, Doravirine/islatravir | Merck Sharp & Dohme LLC | HIV Infection | 12/25 | 09/28 | | |
| Completed | 2 | 42 | Europe, US, RoW | DOR/ISL, MK-8591A, Doravirine/islatravir | Merck Sharp & Dohme LLC | HIV-1 Infection | 12/21 | 01/23 | | |
| MK-8591B / Merck (MSD) |
| No trials found |
| islatravir prodrug (BRII-732) / Brii Biosci |
| No trials found |
