Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine
NCT ID: NCT05140603
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2021-12-01
2023-10-01
Brief Summary
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Detailed Description
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All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021).
Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Cases
Patients who received a doravirine-based regimen.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Switched to a doravirine-based ART regimen under clinician criteria.
Exclusion Criteria
* Major mutations to any of the other drugs combined with doravirine.
* Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Nuria Espinosa Aguilera
Role: PRINCIPAL_INVESTIGATOR
Virgen del Rocío University Hospital
Locations
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Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Nuria Espinosa Aguilera
Role: primary
Carlos García Pérez
Role: backup
Other Identifiers
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FIS-DOR-2021-01
Identifier Type: -
Identifier Source: org_study_id