*Ph 3 Rollover study of DOR/ISL in HIV-1
Research type
Research Study
Full title
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
IRAS ID
1004071
Contact name
Elizabeth Martin
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-001191-14
Clinicaltrials.gov Identifier
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 now expect to live near-normal lifespans.
The current standard-of-care for the treatment of HIV-1 is a combination of 2 drugs, NRTIs (nucleoside analog reverse transcriptase inhibitor) with a third agent. However, there is a need for simpler and safer drug combinations with reduced long-term drug exposure.
There is evidence that simplified 2-drug regimens can achieve the same results compared to 3-drug regimens, while being better tolerated, improving quality of life, and sustaining suppression of the HIV viral load. Doravirine/Islatravir (also known as DOR/ISL, or MK-8591A) is a 2-drug combination and has the potential to be an ideal agent for the treatment of HIV-1 infection due to its strong antiretroviral activity.
In the global HIV community uninterrupted access to experimental treatments for participants who are receiving benefits has become an expectation of clinical study participation. After completion of prior MSD-sponsored DOR/ISL clinical studies, this rollover study will provide continued access to DOR/ISL for eligible participants, until it becomes commercially available.This rollover clinical study is an unblinded, open-label trial and globally will recruit approximately 2000 male and female participants with HIV-1 treated with DOR/ISL in a previous DOR/ISL study. Each participant will be in the study for approximately 54 weeks. Each participant will receive study intervention for approximately 48 weeks. After the end of treatment, each participant will be followed for 42 days.
The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), and will take place at 6 study centers in the UK.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0189
Date of REC Opinion
15 Oct 2021
REC opinion
Further Information Favourable Opinion