Clinical trial NCT05421806: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
Official title: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV I Infection
Keywords: HIV
Lead sponsor: NEAT ID Foundation
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-06-16
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 European sites.

The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.


Eligibility criteria: 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
* 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.

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
* Patients with no documented resistance testing.
* Patients with no genotype available at DOR initiation
* Patients enrolled in DOR trials

Primary outcomes:
measure: Proportion of patients, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.
timeFrame: Week 48 after DOR initiation
measure: Proportion of patients with virologic failure (Cohort 1 - treatment naive)
timeFrame: on or after week 48 after DOR initiation
measure: Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)
timeFrame: up to 12 months after initiation of DOR
measure: Proportion of patients switched for reasons other than virological failure.
timeFrame: up to 12 months after initiation of DOR
Secondary outcomes:
measure: Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
timeFrame: on or after week 48 after DOR initiation
measure: Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
timeFrame: up to 12 months after initiation of DOR
measure: Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)
timeFrame: up to 12 months after initiation of DOR
measure: HIV resistance mutations subtypes for all DOR treated patients with virologic failure
timeFrame: during the 12-month data collection period.
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hopital Universitaire Pitie-Salpetriere
city: Paris
country: France
facility: St Louis Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Trust
name: Anton Pozniak
role: STUDY_DIRECTOR
References: