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

Completed

• Conditions: HIV I Infection

• Registration Number: NCT05421806
• Lead Sponsor: NEAT ID Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Study Start: 2022-10-10
• Primary Completion: 2023-02-28
• Study Completion: 2023-08-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients switched for reasons other than virological failure.	up to 12 months after initiation of 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, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.	Week 48 after DOR initiation
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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)	up to 12 months after initiation of DOR	i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA \< 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA \< 200 copies/mL.
Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)	up to 12 months after initiation of DOR
HIV resistance mutations subtypes for all DOR treated patients with virologic failure	during the 12-month data collection period.

Trial Locations

Locations (4)

Hopital Universitaire Pitie-Salpetriere; 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France

St Louis Hospital; 🇫🇷 Paris, France

Guy's Hospital; 🇬🇧 London, United Kingdom