Trial to test DOR/ISL in people living with HIV-1 who took DOR/ISL before in other trials

• Research type

  Research Study

• Full title

  A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

• IRAS ID

  1007083

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT05766501

• 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 UK 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.
  Around 1300 male and female participants will be enrolled. Participants must be 18 years of age or older and have taken DOR/ISL in a trial that was sponsored by MSD.
  There may be Screening Phase of up to 1 month, depending on which DOR/ISL trial the participant was in before.
  All participants will receive treatment with DOR/ISL for 24 months and will visit the trial site about 10 times during the Treatment Phase. DOR/ISL is a tablet taken once a day.
  After the participants stop getting the trial drug, they will enter the Follow-up Phase with at least 1 visit about 6 weeks after the last dose of the trial drug. Participants may have additional follow-up visits depending on blood test results or if they stop taking trial drug early.
  Participants who complete the last visit may be given an opportunity to continue receiving 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

  London - Riverside Research Ethics Committee

• REC reference

  23/LO/0164

• Date of REC Opinion

  17 Apr 2023

• REC opinion

  Further Information Favourable Opinion