Status:
ACTIVE_NOT_RECRUITING
A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
Lead Sponsor:
NEAT ID Foundation
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV I Infection
Eligibility:
All Genders
18+ years
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. Retrosp...
Eligibility Criteria
Inclusion
- 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:
- Category 1: HIV treatment naïve OR
- 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:
- Category 1: HIV treatment naïve OR
- 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
- 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
Key Trial Info
Start Date :
October 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05421806
Start Date
October 10 2022
End Date
May 1 2026
Last Update
December 30 2025
Active Locations (19)
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1
Institute Of Tropical Medicine Antwerp
Antwerp, Belgium
2
Saint-Pierre University Hospital
Brussels, Belgium
3
Hospital Center University De Montpellier
Montpellier, France
4
CHU de Nantes
Nantes, France