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A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe (DrEW)
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.
Details
| Lead sponsor | NEAT ID Foundation |
|---|---|
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 500 |
| Start date | 2022-10-10 |
| Completion | 2026-05 |
Conditions
- HIV I Infection
Primary outcomes
- Proportion virologically suppressed patients at week 48 who have remained on DOR. — Week 48 after DOR initiation
Proportion of patients, virologically suppressed/undetectable (\<50 copies/mL) at week 48 who have remained on DOR. - Proportion of patients with virologic failure (Cohort 1 - treatment naive) — 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 - Proportion of patients with virologic failure (Cohort 2 - treatment suppressed) — 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 - Proportion of patients switched for reasons other than virological failure. — up to 12 months after initiation of DOR
Proportion of patients switched at any time point for reasons other than virological failure.
Countries
Belgium, France, Netherlands, Spain, United Kingdom