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

NEAT ID Foundation

Status: Active, not recruiting

Conditions: HIV I Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05421806

NEAT 1010 (Other Identifier)

NEAT1010

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Cohort 1

Description:

400 patients with no resistance mutations to DOR or NNRTIs.

Cohort 2

Description:

Approximately 50 patients with resistance mutations to NNRTIs (other than DOR)

Cohort 3

Description:

Approximately 50 patients with or without NNRTI mutations (including DOR)