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New Long Acting Potent Nuke MK-8591 + Doravirine Phase 2B Study Starts
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Not Yet Recruiting New: MK-8591 With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
IAS: Weekly Oral MK-8591 Protects Male Rhesus Macaques against Repeated Low Dose Intrarectal Challenge with SHIV109CP3 - (07/23/17)
IAS: Single doses as low as 0.5 mg of the novel NRTTI MK-8591 suppress HIV for at least seven days - (07/25/17)
CROI: Long-Acting Oral and Parenteral Dosing of MK-8591 for HIV Treatment or Prophylaxis - (02/24/16)
CROI: A Single Monotherapy Dose of MK-8591,a Novel NRTI, Suppresses HIV for Ten Days - (02/24/16)
MK-8591 Concentrations at Sites of HIV Transmission and Replication - (02/23/17)
EFdA / MK-8591 - HIV pre-exposure prophylaxis for women and infants prevents vaginal and oral HIV transmission in a preclinical model of HIV infection - (08/05/16)
Pre-exposure Prophylaxis with EFdA Offers Strong Protection against High Dose Mucosal HIV Challenges - [Long-Acting New NRTI for Treatment & PrEP] - (10/24/16)
MK-8591 With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (DRIVE2Simplify)
Verified September 2017
Purpose
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of MK-8591 in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults
Estimated Enrollment:
120
Anticipated Study Start Date:
November 13, 2017
Participants will be treated once daily (QD) with 0.25 mg MK-8591, 100 mg DOR, 300 mg 3TC, and placebo to MK- 1439A for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to MK-1439A may be discontinued. Around Week 60, participants may be switched to a selected open label dose of MK-8591 and DOR 100 mg QD and continue treatment until Week 120.
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