A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
NCT ID: NCT05421806
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2022-10-10
2026-05-31
Brief Summary
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Retrospective data from 500 patients is planned to be collected from 6 - 10 European sites. Cohort 1 : 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, Cohort 2: 50 patients with NNRTI mutations (other than DOR), Cohort 3: 50 patients with NNRTI mutations (including DOR).
The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
400 patients with no resistance mutations to DOR or NNRTIs.
No interventions assigned to this group
Cohort 2
Approximately 50 patients with resistance mutations to NNRTIs (other than DOR)
No interventions assigned to this group
Cohort 3
Approximately 50 patients with or without NNRTI mutations (including DOR)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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
* 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 genotype available at DOR initiation
* Patients enrolled in DOR trials
* Patients who have DOR as part of their fourth line or higher therapy
* Patients with prior virological failure with agents of the NNRTI class
* Patients who have an INSTI and/or bPI in their DOR-containing therapy
* Patients who have NNRTI mutations that impact on DOR
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
NEAT ID Foundation
OTHER
Responsible Party
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Principal Investigators
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Anton Pozniak
Role: STUDY_DIRECTOR
Chelsea and Westminster NHS Trust
Locations
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Institute Of Tropical Medicine Antwerp
Antwerp, , Belgium
Saint-Pierre University Hospital
Brussels, , Belgium
Hospital Center University De Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU Nantes University Hospital
Nantes, , France
Hospital Center University De Nice
Nice, , France
Bichat-Claude Bernard Hospital
Paris, , France
Hopital Universitaire Pitie-Salpetriere
Paris, , France
Hospital Saint Antoine
Paris, , France
Lariboisière Hospital
Paris, , France
Saint-Louis Hospital
Paris, , France
St Louis Hospital
Paris, , France
University Hospitals Pitié Salpêtrière
Paris, , France
Erasmus University Medical Center
Rotterdam, , Netherlands
Hospital Clínic de Barcelona
Barcelona, , Spain
Southmead Hospital
Bristol, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Mortimer Market Center, Central and North West London NHS Trust
London, , United Kingdom
Countries
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Other Identifiers
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NEAT 1010
Identifier Type: OTHER
Identifier Source: secondary_id
NEAT1010
Identifier Type: -
Identifier Source: org_study_id