DOR/ISL Open-Label Switch
Research type
Research Study
Full title
A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
IRAS ID
275170
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2019-000586-20
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
As treatment regimens have improved, HIV-1 infection has become a chronic, manageable condition and those receiving effective antiretroviral therapy (ART) regimens can expect to live near-normal lifespans. As a result of patients with HIV living longer, it is becoming increasingly important to find treatments that are safe and tolerable long-term.
The current standard of care for the treatment of HIV-1 is a combination of three ART drugs for the best chance of lowering the amount of the HIV virus in the body (also known as virological suppression). Although such regimens are highly effective there is a need for simpler and safer regimens, as there are concerns with the safety of long-term drug use. There is evidence that simplified 2 drug regimens can achieve efficacy similar to a 3-drug regimen. A combination of 2 ART drugs called Doravirine/Islatravir (also known as DOR/ISL, or MK-8591A) has the potential to be an ideal agent for the treatment of HIV-1 infection.
This study is an unblinded, open label study which will recruit approximately 578 patients with HIV-1 who have been virologically supressed for 3 or more months on a stable 2 or 3 drug combination. Patients will be randomised into 1 of 2 treatment groups, group 1 from Day 1 will switch from a standard of care ART to DOR/ISL through to week 96 and group 2 will continue standard of care ART until week 48, then will receive DOR/ISL through to week 96.
The purpose of this study is to assess the percentage of participants on group 1 who are able to maintain virologic suppression after switching to a new antiretroviral regimen compared to group 2.
The study is funded by Merck Sharp & Dohme Limited and will take place at 7 study centres in the UK.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0374
Date of REC Opinion
20 Jan 2020
REC opinion
Further Information Favourable Opinion