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)

Summary

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.

Timeline

Start

2016-01-14

Primary completion

2018-11-28

Completion

2020-10-28

Publications

• Results Wong A, Goldstein D, Mallolas J, DeJesus E, Johnson M, Molina JM, Pozniak A, Rodgers A, Teal V, Hepler D, Kumar S, Sklar P, Hanna GJ, Hwang C, Badshah C, Teppler H. Efficacy and Safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) in Treatment-Naive Adults With HIV-1 and Transmitted Nonnucleoside Reverse Transcriptase Inhibitor Resistance Mutations. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):e47-e49. doi: 10.1097/QAI.0000000000002153.

Drugs

Indications