Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Real-World HIV drug study tracks Doravirine's effectiveness

NCT ID NCT05421806

Disease control Sponsor: NEAT ID Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 500 people with HIV across Europe who are taking the medication doravirine. Researchers want to see how well the drug controls the virus over 12 months, how many people stop taking it, and if the virus becomes resistant. The study includes people new to treatment, those switching from other drugs, and those with specific drug-resistant mutations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

HIV-1 infected patients ≥ 18 years who were ART-naïve or virologically suppressed (VL \< 50 copies for more than 6 months) and have been started/switched to DOR for at least 12 months at time of data collection.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * are HIV positive male or female * are aged ≥18 years * were prescribed and received at least one dose of DOR (without initial dose adjustment). * have started/been switched to DOR for at least 12 months at time of data collection * had a resistance genotype available before starting DOR Cohort 1 Specific Inclusion Criteria * had no evidence of DOR-associated resistance mutation * were on DOR containing ART regimen that also contained 2 fully active nucleos(t)ides and patient had no documented NRTI resistance mutations to the two NRTIs in the combination. * Patients who, at the time of initiation, were: 1. Category 1: HIV treatment naïve OR 2. Category 2: Virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months with no evidence of prior virological failure with agents of the NNRTI class Patients in category 1 and 2 above who have NNRTI mutations that do not impact on DOR (K103N, Y181C, and G190A) using the Stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study. Cohort 2 Specific Inclusion Criteria * must have evidence of NNRTI associated resistance mutations (other than DOR) according to Stanford algorithm * their DOR-containing ART will contain 2 NRTIs but will not include an INSTI and/or a bPI. * had no documented resistance to the other drugs in the combination. * Patients who, at the time of initiation, were: 1. Category 1: HIV treatment naïve OR 2. Category 2: Virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months Cohort 3 Specific Inclusion Criteria * ART naïve or virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months at the time of DOR initiation Exclusion Criteria: * Patients with no documented resistance testing. * Patients with no genotype available at DOR initiation * Patients enrolled in DOR trials Cohort 1 specific exclusion criteria * Patients who have DOR as part of their fourth line or higher therapy * Patients with prior virological failure with agents of the NNRTI class Cohort 2 specific exclusion criteria * Patients who have an INSTI and/or bPI in their DOR-containing therapy * Patients who have NNRTI mutations that impact on DOR

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV I infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV I infection

Contacts and locations

Locations

  • Bichat-Claude Bernard Hospital

    Paris, France

  • CHU Nantes University Hospital

    Nantes, France

  • CHU de Nantes

    Nantes, France

  • Chelsea and Westminster Hospital

    London, United Kingdom

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Guy's Hospital

    London, United Kingdom

  • Hopital Universitaire Pitie-Salpetriere

    Paris, France

  • Hospital Center University De Montpellier

    Montpellier, France

  • Hospital Center University De Nice

    Nice, France

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Saint Antoine

    Paris, France

  • Institute Of Tropical Medicine Antwerp

    Antwerp, Belgium

  • Lariboisière Hospital

    Paris, France

  • Mortimer Market Center, Central and North West London NHS Trust

    London, United Kingdom

  • Saint-Louis Hospital

    Paris, France

  • Saint-Pierre University Hospital

    Brussels, Belgium

  • Southmead Hospital

    Bristol, United Kingdom

  • St Louis Hospital

    Paris, France

  • University Hospitals Pitié Salpêtrière

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.