Clinical trial to test DOR/ISL in people living with HIV-1 who have never taken HIV-1 treatment

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

• IRAS ID

  1007057

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• 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. Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) is a standard treatment for HIV-1.

  Around 500 male and female participants will be enrolled. Participants must be 18yrs or older and be ‘treatment naïve’ for their HIV-1.

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

  Participants will receive treatment for 96 weeks (2yrs). DOR/ISL, BIC/FTC/TAF and 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. Trial treatment will be extended open-label for participants who become pregnant on trial and consent to continue trial intervention.

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

• REC name

  Wales REC 1

• REC reference

  23/WA/0055

• Date of REC Opinion

  7 Jul 2023

• REC opinion

  Further Information Favourable Opinion