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Last Updated: June 29, 2022

CLINICAL TRIALS PROFILE FOR DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE


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All Clinical Trials for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02397096 ↗ 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 Transcrip Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2015-06-09 The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.
NCT02403674 ↗ Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2015-06-05 The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week double-blind period and a 96-week open-label period. The present results are based on the first 48 weeks of this ongoing study.
NCT02629822 ↗ Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030) Completed Merck Sharp & Dohme Corp. Phase 2 2016-01-14 The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.
NCT03332095 ↗ Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents Active, not recruiting National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 2018-03-21 The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.
NCT04097925 ↗ Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals Recruiting Hospital Universitari de Bellvitge Phase 2 2020-02-18 This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Intervention Trials
Hiv 3
HIV-1-infection 3
HIV-1 Infection 2
HIV Infections 1
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Condition MeSH

Condition MeSH for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Intervention Trials
HIV Infections 4
Acquired Immunodeficiency Syndrome 3
Immunologic Deficiency Syndromes 2
Weight Gain 1
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Clinical Trial Locations for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Location Trials
United States 28
South Africa 7
Russian Federation 5
Spain 5
Thailand 4
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Trials by US State

Trials by US State for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Location Trials
Colorado 3
Maryland 2
Illinois 2
Florida 2
District of Columbia 2
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Clinical Trial Progress for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase Trials
Recruiting 5
Active, not recruiting 3
Enrolling by invitation 1
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Clinical Trial Sponsors for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Merck Sharp & Dohme Corp. 5
Professor Francois Venter 2
Willem Daniel Francois Venter 2
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Sponsor Type

Sponsor Type for Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
Sponsor Trials
Other 12
Industry 6
NIH 1
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Serving leading biopharmaceutical companies globally:

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Colorcon

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