A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/

NCT05421806 | Active Not Recruiting

• 2 other identifiers: NEAT1010NEAT 1010
• Study Type: observational
• Target: 500
• Locations: 5 countries
• Sites: 19

Brief Summary

Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period. 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.

Conditions

HIV I Infection

Keywords

HIV

Outcome Measures

Primary Outcomes (4)

• Proportion virologically suppressed patients at week 48 who have remained on DOR.

  Proportion of patients, virologically suppressed/undetectable (\<50 copies/mL) at week 48 who have remained on DOR.

  Week 48 after DOR initiation

• Proportion of patients with virologic failure (Cohort 1 - treatment naive)

  i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL

  on or after week 48 after DOR initiation

• Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)

  i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA \< 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 50 copies/mL

  up to 12 months after initiation of DOR

• Proportion of patients switched for reasons other than virological failure.

  Proportion of patients switched at any time point for reasons other than virological failure.

  up to 12 months after initiation of DOR

Secondary Outcomes (4)

• Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)

  on or after week 48 after DOR initiation

• Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)

  up to 12 months after initiation of DOR

• Estimated proportion of patients with low level viremia

  up to 12 months after initiation of DOR

• HIV resistance subtypes for patients with virologic failure

  during the 12-month data collection period.

Study Arms (3)

Cohort 1

400 patients with no resistance mutations to DOR or NNRTIs.

Cohort 2

Approximately 50 patients with resistance mutations to NNRTIs (other than DOR)

Cohort 3

Approximately 50 patients with or without NNRTI mutations (including DOR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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:
• Category 1: HIV treatment naïve OR
• 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:

You may not qualify if:

• Patients with no documented resistance testing.
• 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

Sponsors & Collaborators

• NEAT ID Foundation: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (19)

Institute Of Tropical Medicine Antwerp

Antwerp, Belgium

Location

Saint-Pierre University Hospital

Brussels, Belgium

Location

Hospital Center University De Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

CHU Nantes University Hospital

Nantes, France

Location

Hospital Center University De Nice

Nice, France

Location

Bichat-Claude Bernard Hospital

Paris, France

Location

Hopital Universitaire Pitie-Salpetriere

Paris, France

Location

Hospital Saint Antoine

Paris, France

Location

Lariboisière Hospital

Paris, France

Location

Saint-Louis Hospital

Paris, France

Location

St Louis Hospital

Paris, France

Location

University Hospitals Pitié Salpêtrière

Paris, France

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Southmead Hospital

Bristol, United Kingdom

Location

Chelsea and Westminster Hospital

London, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Mortimer Market Center, Central and North West London NHS Trust

London, United Kingdom

Location

Study Officials

• Anton Pozniak

  Chelsea and Westminster NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: October 10, 2022
• Primary Completion: March 6, 2026
• Study Completion: May 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); FR (11); ES (1); NL (1); GB (4)