Clinical Trials in France / NCT05421806
Active, not recruiting
Observational
A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
NCT05421806 · tracked via the Priya Life Science France tracker
Condition(s) studied
HIV I Infection
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
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:
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.
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:
1. Category 1: HIV treatment naïve OR
2. 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
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 |
Other trials for the same condition
Official registry record
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 France