DOR/ISL 100 mg/0.25 mg QD Blinded Switch

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

• IRAS ID

  1006916

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT05630755

• Research summary

  As treatment regimens have improved, HIV-1 infection has become a chronic, manageable condition. The current standard of care includes 3-drug regimens. However, there is evidence 2-drug regimens can be as effective whilst improving tolerability and quality of life, which in turn may support patient adherence to treatment and continued suppression of disease.

  This trial is testing Doravirine (DOR)/ Islatravir (ISL), also called MK-8591A, in people with HIV-1. DOR/ISL is a combination of 2 drugs: DOR (approved by some health authorities to treat HIV-1) and ISL(an experimental drug not approved to treat HIV-1). DOR/ISL has the potential to be an effective 2-drug regimen due to its effects against HIV-1, multiple mechanisms of action and lack of food requirements. Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) is a standard treatment for HIV-1.

  Around 501 male and female participants will be enrolled in this trial. Participants must be 18 years of age or older and have been getting BIC/FTC/TAF to control their HIV-1 for at least 3 months.

  After a screening phase of up to 45 days, eligible participants will be randomised in a 2:1 ratio into 1 of 2 treatment groups:
  • Group 1: DOR/ISL and a placebo
  • Group 2: BIC/FTC/TAF and placebo

  Participants will receive treatment for 96 weeks (2 years). DOR/ISL, BIC/FTC/TAF, and the placebo are tablets taken once a day.

  After the participants stop getting the trial drugs, they will enter the follow-up phase. Participants may have additional follow-up visits depending on blood test results, if the participant continues treatment during pregnancy or if they stop taking trial drugs early.

  Participants who complete the last visit may be given an opportunity to receive open-label DOR/ISL until it is commercially available, provided the development of DOR/ISL continues.

  The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  23/EE/0002

• Date of REC Opinion

  22 Feb 2023

• REC opinion

  Further Information Favourable Opinion