HIV I Infection
Conditions
Keywords
HIV
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 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.
Interventions
None listed
Sponsors
NEAT ID Foundation
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive) | on or after week 48 after DOR initiation | 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 | up to 12 months after initiation of DOR | Estimated proportion of patients with low level viremia (≥50-\<200 copies/mL) |
| HIV resistance subtypes for patients with virologic failure | during the 12-month data collection period. | HIV resistance mutations subtypes for all DOR treated patients with virologic failure |
Countries
Belgium, France, Netherlands, Spain, United Kingdom
Contacts
STUDY_DIRECTORAnton Pozniak
Chelsea and Westminster NHS Trust
Outcome results
None listed