DORDOL
Research type
Research Study
Full title
Efficacy of doravirine + dolutegravir dual therapy in the context of antiretroviral therapy switch
IRAS ID
286685
Contact name
Marta Boffito
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Eudract number
2020-003928-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Timely and effective combination antiretroviral therapy (cART) is associated with a normalization of life expectancy. With earlier initiation of cART, most people living with HIV can expect to be on cART for decades with an increasing focus on long-term safety and toxicity of drugs.
There is increasing evidence to support the efficacy of dual cART, as opposed to the established option of three-drug cART, with a view to reducing drug exposure and consequently drug-related toxicity. Dual cART options are now included in consensus treatment guidelines.
Dolutegravir (DTG)-based cART has been evaluated in switch studies with rilpivirine (RPV) or lamivudine (3TC) in SWORD and TANGO respectively, however these dual regimens have important limitations such as drug-drug interactions and resistance.
Doravirine (DOR) is a well-tolerated non-nucleoside reverse transcriptase inhibitor with a high barrier to resistance in vitro, and, with the exception of St John’s Wort, no known important drug-drug interactions with common over the counter medications.
Known side effects associated with other therapy combinations may be avoided with a dual cART of doravirine + dolutegravir (DTG), and this regimen offers a combination of two high genetic barrier drugs and the opportunity to reduce an individual’s lifetime drug exposure.
The primary aim of this study is to evaluate the efficacy of switching from suppressive triple cART to DOR+DTG dual cART in people living with HIV on cART with an undetectable viral load. 2/3 of participants will switch to DOR+DTG immediately receive DOR+DTG for 96 weeks. 1/3 will maintain their current cART followed by a switch to DOR+DTG at week 48 of the trial, then remain on DOR+DTG for an additional 48 weeks. All participants will then be followed up for a further 30 days.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0875
Date of REC Opinion
18 Jan 2022
REC opinion
Further Information Favourable Opinion