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NCT Number: NCT05421806

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV I Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute Of Tropical Medicine Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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:
  • Category 1: HIV treatment naïve OR
  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: Week 48 after DOR initiation

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

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

    Time frame: on or after week 48 after DOR initiation

    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

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

    Time frame: up to 12 months after initiation of DOR

    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

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

    Time frame: up to 12 months after initiation of DOR

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

Secondary outcomes

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

    Time frame: on or after week 48 after DOR initiation

    i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA < 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 200 copies/mL.

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

    Time frame: up to 12 months after initiation of DOR

    i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA < 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 200 copies/mL.

  3. Estimated proportion of patients with low level viremia

    Time frame: up to 12 months after initiation of DOR

    Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)

  4. HIV resistance subtypes for patients with virologic failure

    Time frame: during the 12-month data collection period.

    HIV resistance mutations subtypes for all DOR treated patients with virologic failure

Sponsors and collaborators

Lead sponsor

NEAT ID Foundation

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe

Acronym: DrEW

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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