DOR/ISL in heavily treatment-experienced participants
Research type
Research Study
Full title
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
IRAS ID
278825
Contact name
Margaret Johnson
Contact email
Eudract number
2019-000588-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 17 days
Research summary
Heavily treatment-experienced (HTE) individuals are a small but important population of patients with HIV-1. These individuals have exhausted all or nearly all antiretroviral options for constructing a viable HIV treatment regimen primarily because of extensive multidrug resistance but also because of drug intolerance, lack of access to key drugs, or unacceptability to the participant. There is consequently an unmet medical need in this population for better treatment options. Preliminary data suggest Islatravir (ISL) may be useful in this population.
Islatravir is the first of a new class of antiretroviral agents, and Doravirine (DOR) is an European Medicines Agency (EMA) and Food and Drug Administration (FDA) approved antiretroviral drug, both of which work by blocking steps in the HIV-1 virus replication, thus reducing the levels of the virus in the patient and consequently allowing the immune system to repair itself and prevent further damage.
Doravirine/Islatravir (DOR/ISL) combination drug has the potential to be an ideal agent for the treatment of HIV-1 infection in the HTE population due to its potent antiretroviral activity by multiple mechanisms of action, lack of food requirements, and favourable safety and Drug-drug Interaction (DDI) profiles observed to date.
This 2-part, multicentre phase 3 study will recruit approximately 100 male and female participants over the age of 12. This study will assess the anti-retroviral activity of DOR/ISL compared to placebo, and the safety and tolerability of DOR/ISL. For part 1, participants will be assigned randomly into 1:2:1:1 to one of 4 treatment arms for day 1 to day 7 of the study. For part 2, all participants will receive DOR/ISL plus optimised background therapy from day 8 to week 49.
The study is funded by Merck Sharp & Dohme Limited and will take place at 8 study centres in the UK.
REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0845
Date of REC Opinion
15 Jun 2020
REC opinion
Favourable Opinion