A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
Condition(s) studied
Study 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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute Of Tropical Medicine Antwerp | Antwerp | Belgium | |
| Saint-Pierre University Hospital | Brussels | Belgium | |
| Hospital Center University De Montpellier | Montpellier | France | |
| CHU de Nantes | Nantes | France | |
| CHU Nantes University Hospital | Nantes | France | |
| Hospital Center University De Nice | Nice | France | |
| Bichat-Claude Bernard Hospital | Paris | France | |
| Hopital Universitaire Pitie-Salpetriere | Paris | France | |
| Hospital Saint Antoine | Paris | France | |
| Lariboisière Hospital | Paris | France | |
| Saint-Louis Hospital | Paris | France | |
| St Louis Hospital | Paris | France | |
| University Hospitals Pitié Salpêtrière | Paris | France | |
| Erasmus University Medical Center | Rotterdam | Netherlands | |
| Hospital Clínic de Barcelona | Barcelona | Spain | |
| Southmead Hospital | Bristol | United Kingdom | |
| Chelsea and Westminster Hospital | London | United Kingdom | |
| Guy's Hospital | London | United Kingdom | |
| Mortimer Market Center, Central and North West London NHS Trust | London | United Kingdom |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05421806 on ClinicalTrials.gov ↗ ← All trials in Spain