elsulfavirine: Clinical Trials

9 completed, 2 unknown. 8 Phase 1, 3 Phase 2, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	8	Completed 7, Unknown 1
Phase 2	3	Completed 3
Phase 3	1	Completed 1

Follow elsulfavirine: new trials by email Literature Review of elsulfavirine trials Research Report on elsulfavirine

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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
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects Elsulfavirine - HIV-1-infection	Phase 1	Completed	Viriom	24	2022-04-12	2023-02-21
An Open-label Clinical Study of the Pharmacokinetics and Safety of Elsulfavirine, 200 mg Tablets, With Single and Multiple Oral Administration in Healthy Volunteers Elsulfavirine - Covid19, HIV-1-infection	Phase 1	Completed	Viriom	15	2021-01-23	2021-12-09
Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA® VM-1500A-LAI, ELPIDA® - HIV-1-infection	Phase 1 / Phase 2	Completed	Viriom	36	2021-01-19	2022-01-11
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers Elpida, placebo - HIV Infections	Phase 1	Unknown	Viriom	24	2019-05-01	2019-05-20
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers Elpida - HIV Infections	Phase 1	Completed	Viriom	36	2018-12-18	2022-01-24
Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs Elpida®, Rifampin, Rifabutin - HIV-1-infection	Phase 1	Completed	Viriom	56	2018-11-14	2022-01-26
Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia Dasatinib - Chronic Myelogenous Leukemia	Phase 2	Completed	Hikma Pharmaceuticals LLC	56	2018-11-05	2023-09-22
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs Elpida®, Dolutegravir, Sofosbuvir - HIV-1-infection, Hepatic Impairment	Phase 1	Completed	Viriom	36	2018-10-01	2022-01-11
Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects VM-1500FDC, Elpida®, Truvada® - HIV-1-infection	Phase 1	Completed	Viriom	140	2018-06-01	2018-10-30
Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART Elpida® + 2 NRTIs - HIV-1-infection		Unknown	Viriom	2000	2018-03-15	2018-10-18
Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy VM-1500, Efavirenz, Antiretroviral therapy (ART) - HIV-1-infection	Phase 2 / Phase 3	Completed	Viriom	150	2014-08-05	2018-09-25

Conditions studied

HIV Infections (2)  ·  Acquired Immunodeficiency Syndrome (1)  ·  COVID-19 (1)  ·  Leukemia, Myelogenous, Chronic, BCR-ABL Positive (1)  ·  Leukemia, Myeloid, Chronic-Phase (1)

Sponsors

Viriom (10)  ·  Hikma Pharmaceuticals LLC (1)

Countries

Russia (8)  ·  Jordan (1)  ·  Lebanon (1)  ·  Saudi Arabia (1)  ·  Thailand (1)  ·  Tunisia (1)  ·  United States (1)

Top investigators

Alla Andreeva, PhD (2)  ·  Anastasia Pokrovskaya, PhD (1)  ·  Brett Smith, MD, PhD (1)  ·  Elena Mazygula, PhD (1)  ·  Elena Smolyarchuk, MD, PhD (1)  ·  Elena Smolyarchuk, PhD (1)  ·  Elena Yakubova, PhD (1)  ·  Irina Rodyukova, PhD (1)  ·  Irina Y Tyrnova (1)  ·  Somruedee Chatsiricharoenkul, Assoc. Prof., MD (1)