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Active Not RecruitingNCT05421806

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
NEAT ID Foundation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2022-10-10
Primary completion
2026-03-06
Completion
2026-05-01
First posted
2022-06-16
Last updated
2025-12-30

Locations

19 sites across 5 countries: Belgium, France, Netherlands, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT05421806. Inclusion in this directory is not an endorsement.

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/ (NCT05421806) · Clinical Trials Directory