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Be Part of Research - Trial Details - DOR/ISL in HIV-1 Antiretroviral Treatment-naĂŻve Participants (MK-8591A-053)
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DOR/ISL in HIV-1 Antiretroviral Treatment-naĂŻve Participants (MK-8591A-053)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London Bristol London Manchester London

Medical Conditions

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naĂŻve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 Oct 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.

Intervention Arm Group : DOR/ISL;

Intervention Type : DRUG
Intervention Description : Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

Intervention Arm Group : BIC/FTC/TAF;

Intervention Type : DRUG
Intervention Description : Placebo tablet matched to DOR/ISL tablet taken by mouth.

Intervention Arm Group : BIC/FTC/TAF;

Intervention Type : DRUG
Intervention Description : Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Intervention Arm Group : DOR/ISL;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College Hospital ( Site 7950)
    London
    London, City Of
    SE5 9RL
  • Southmead Hospital ( Site 7952)
    Bristol
    Bristol, City Of
    BS10 5NB
  • Royal London Hospital ( Site 7951)
    London
    England
    E1 1BB
  • The Hathersage Centre ( Site 7953)
    Manchester
    England
    M13 0FH
  • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
    London
    London, City Of
    WC1E 6JB


The study is sponsored by Merck Sharp & Dohme LLC



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Read full details for Trial ID: NCT05705349
Last updated 18 October 2024

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