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

HIV I Infection Clinical Trial

— DrEW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421806
• Other study ID #: NEAT1010
• Secondary ID: NEAT 1010
• Status: Completed
• Start date: October 10, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: September 2023
• Source: NEAT ID Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: August 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

• 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

Related Conditions & MeSH terms

• HIV I Infection

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	Hopital Universitaire Pitie-Salpetriere	Paris
France	St Louis Hospital	Paris
United Kingdom	Guy's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
NEAT ID Foundation	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.		Week 48 after DOR initiation
Primary	Proportion of patients with virologic failure (Cohort 1 - treatment naive)	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	on or after week 48 after DOR initiation
Primary	Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)	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	up to 12 months after initiation of DOR
Primary	Proportion of patients switched for reasons other than virological failure.		up to 12 months after initiation of DOR
Secondary	Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)	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.	on or after week 48 after DOR initiation
Secondary	Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)	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.	up to 12 months after initiation of DOR
Secondary	Estimated proportion of patients with low level viremia (=50-<200 copies/mL)		up to 12 months after initiation of DOR
Secondary	HIV resistance mutations subtypes for all DOR treated patients with virologic failure		during the 12-month data collection period.