DOR/ISL 100 mg/0.25 mg QD 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 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

• IRAS ID

  1006970

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT05631093

• Research summary

  As treatment regimens improve, HIV-1 infection has become a chronic, manageable condition. The current standard of care includes 3-drug regimens which are tolerable & effective. However, there is evidence that 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 a switch from Antiretroviral Therapy (ART) to Doravirine (DOR)/ Islatravir (ISL), also called MK-8591A in people living with HIV-1.

  MK-8591A or ‘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.
  About 501 male and female participants, aged 18 years and older, will take part in this trial. There is a screening phase, lasting about 45 days, to see if patients can join the trial. Participants are randomised in a 2:1 ratio:
  • Group 1: switch from ART to DOR/ISL (100 mg/0.25 mg daily) after joining the trial, continuing on DOR/ISL for up to 2 years.
  • Group 2: keep getting ART for about 1 year after they join the trial then switch to DOR/ISL (100 mg/0.25 mg daily) for up to 1 year.

  After the participant stops trial treatment, they will complete a site visit about 42 days after the end of
  treatment.

  Participants who complete the last visit may be able to continue on ‘open label’ DOR/ISL.

  The duration of the trial will be approximately 2.5 years.

  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/0001

• Date of REC Opinion

  22 Feb 2023

• REC opinion

  Further Information Favourable Opinion