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Official Title A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Fixed-dose Combination Doravirine-Tenofovir disoproxil fumarate-Lamivudine (MK-1439A) Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02403674
Treatments
Doravirine
, Doravirine
Tradename:PifeltroOther Names:DORClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Doravirine-Tenofovir DF-Lamivudine
Doravirine-Tenofovir DF-Lamivudine
Tradename:DelstrigoOther Names:DOR-TDF-3TC, Doravirine-Tenofovir disoproxil fumarate-LamivudineClass:Single-Tablet RegimensCategories Treatment-Naive
Funding
IndustryMerck
References
- Orkin C, Squires KE, Molina JM, et al. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis. 2019;68:535-44.
Official Title A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment-Naïve HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02275780
Treatments
Doravirine
Doravirine
Tradename:PifeltroOther Names:DORClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryMerck
References
- Molina JM, Squires K, Sax PE, et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018;5:e211-e220.
Official Title A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to doravirine plus lamivudine plus tenofovir disoproxil fumarate in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Phase Phase III
ClinicalTrials.gov NCT02397096
Treatments
Doravirine
, Doravirine
Tradename:PifeltroOther Names:DORClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Doravirine-Tenofovir DF-Lamivudine
Doravirine-Tenofovir DF-Lamivudine
Tradename:DelstrigoOther Names:DOR-TDF-3TC, Doravirine-Tenofovir disoproxil fumarate-LamivudineClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryMerck Sharp & Dohme Corp
References
- Johnson M, Kumar P, Molina JM, et al. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2019;81:463-72.
Common TitleMK-1439-007 Industry
Official Title Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of Doravirine (MK-1439) Plus TRUVADA Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients
Phase Phase IIB
ClinicalTrials.gov NCT01632345
Treatments
Doravirine
Doravirine
Tradename:PifeltroOther Names:DORClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryMerck Sharp & Dohme Corp
References
- Gatell JM, Morales-Ramirez JO, Hagins DP, et al. Doravirine dose selection and 96-week safety and efficacy versus efavirenz in antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial. Antivir Ther. 2019;24:425-35.
Common TitleMK-1439A-028 Industry
Official Title Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects.
Phase Phase IIB
ClinicalTrials.gov NCT02652260
Treatments
Doravirine
, Doravirine
Tradename:PifeltroOther Names:DORClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Doravirine-Tenofovir DF-Lamivudine
Doravirine-Tenofovir DF-Lamivudine
Tradename:DelstrigoOther Names:DOR-TDF-3TC, Doravirine-Tenofovir disoproxil fumarate-LamivudineClass:Single-Tablet RegimensFunding
IndustryMerck
References
No references available for this clinical trial
Doravirine Slide Deck
February 22, 2020
Clinical Trial Image Decks
DRIVE AHEAD - November 25, 2022
DRIVE FORWARD - November 25, 2022
DRIVE SHIFT - November 25, 2022