HIV I InfectionDrEWNCT05421806
A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
An observational study of HIV I Infection, run by NEAT ID Foundation at 19 sites in 5 countries.
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 500 patients is planned to be collected from 6 - 10 European sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection
- How many people
- 500 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 10 Oct 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 infected patients ≥ 18 years who were ART-naïve or virologically suppressed (VL < 50 copies for more than 6 months) and have been started/switched to DOR for at least 12 months at time of data collection.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
France11 sites
Hospital Center University De Montpellier
Montpellier
CHU de Nantes
Nantes
CHU Nantes University Hospital
Nantes
Hospital Center University De Nice
Nice
Bichat-Claude Bernard Hospital
Paris
Hopital Universitaire Pitie-Salpetriere
Paris
Hospital Saint Antoine
Paris
Lariboisière Hospital
Paris
Saint-Louis Hospital
Paris
St Louis Hospital
Paris
University Hospitals Pitié Salpêtrière
Paris
United Kingdom4 sites
Southmead Hospital
Bristol
Chelsea and Westminster Hospital
London
Guy's Hospital
London
Mortimer Market Center, Central and North West London NHS Trust
London
Belgium2 sites
Institute Of Tropical Medicine Antwerp
Antwerp
Saint-Pierre University Hospital
Brussels
About this study
Official title: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe
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.
- Conditions
- HIV I Infection
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 400 patients with no resistance mutations to DOR or NNRTIs. | |
| Cohort 2 | Approximately 50 patients with resistance mutations to NNRTIs (other than DOR) | |
| Cohort 3 | Approximately 50 patients with or without NNRTI mutations (including DOR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion virologically suppressed patients at week 48 who have remained on DOR.
Proportion of patients, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.
Measured: Week 48 after DOR initiation
Proportion of patients with virologic failure (Cohort 1 - treatment naive)
- 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
Measured: on or after week 48 after DOR initiation
Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)
- 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
Measured: up to 12 months after initiation of DOR
Proportion of patients switched for reasons other than virological failure.
Proportion of patients switched at any time point for reasons other than virological failure.
Measured: up to 12 months after initiation of DOR
Secondary outcomes (4)
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
- 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.
Measured: on or after week 48 after DOR initiation
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
- 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.
Measured: up to 12 months after initiation of DOR
Estimated proportion of patients with low level viremia
Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)
Measured: up to 12 months after initiation of DOR
HIV resistance subtypes for patients with virologic failure
HIV resistance mutations subtypes for all DOR treated patients with virologic failure
Measured: during the 12-month data collection period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start10 Oct 2022
- Primary completion6 Mar 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEAT ID Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Anton Pozniak, Study director, Chelsea and Westminster NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421806
- Sponsor's protocol ID
- NEAT1010
- Other IDs
- NEAT 1010
- Acronym
- DrEW
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe
- ClinicalTrials.gov ID
- NCT05421806
- Acronym / sponsor ID
- DrEW / NEAT1010
- Conditions
- HIV I Infection
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NEAT ID FoundationUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –400 patients with no resistance mutations to DOR or NNRTIs. |
| Cohort 2 | – | –Approximately 50 patients with resistance mutations to NNRTIs (other than DOR) |
| Cohort 3 | – | –Approximately 50 patients with or without NNRTI mutations (including DOR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected patients ≥ 18 years who were ART-naïve or virologically suppressed (VL < 50 copies for more than 6 months) and have been started/switched to DOR for at least 12 months at time of data collection.
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion virologically suppressed patients at week 48 who have remained on DOR.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: up to 12 months after initiation of DOR
Proportion of patients switched at any time point for reasons other than virological failure.
4 secondary outcomes
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
Time frame: on or after week 48 after DOR initiation
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)
Time frame: up to 12 months after initiation of DOR
Estimated proportion of patients with low level viremia
Time frame: up to 12 months after initiation of DOR
HIV resistance subtypes for patients with virologic failure
Time frame: during the 12-month data collection period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Pozniak study director
Chelsea and Westminster NHS Trust
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV I Infection, run by NEAT ID Foundation at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, United Kingdom, Belgium, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion virologically suppressed patients at week 48 who have remained on DOR. (time frame: Week 48 after DOR initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.