Clinical trial NCT05140603: Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine
Official title: Ambispective Cohort Study to Evaluate the Effectiveness, Safety and Tolerance of a Doravirine-based Antirretroviral Regimen as a Switching Strategy in Virologically Supressed HIV Infected Patients: Real-world Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hiv
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who were switched to a doravirine-based regimen from the date of its availability in our center (September 2020) due to clinical considerations and have records available will be retrospectively included until the study approval date (expected July 2021).

Minor resistances in a baseline genotype to NNRTI or prior failure to NNRTI such as nevirapine or efavirenz will be accepted if doravirine is combined with a fully active high genetic barrier drug.

Brief summary: Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.

Detailed description: Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.

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.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years HIV-1 infected subjects.
* Switched to a doravirine-based ART regimen under clinician criteria.

Exclusion Criteria:

* Doravirine major resistance mutations (accessory mutations are allowed).
* Major mutations to any of the other drugs combined with doravirine.
* Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.

Primary outcomes:
measure: Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.
timeFrame: Up to 96 weeks.
Secondary outcomes:
measure: Rate of changes in renal biomarkers.
timeFrame: Up to 48 weeks.
measure: Rate of changes in hepatic parameters.
timeFrame: Up to 48 weeks.
measure: Rate of changes in lipid parameters.
timeFrame: Up to 48 weeks
measure: Tolerability rate of study patients.
timeFrame: Up to 48 weeks.
measure: Death rates among trial patients.
timeFrame: Up to 48 weeks.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Virgen del Rocío University Hospital
name: Nuria Espinosa Aguilera
role: PRINCIPAL_INVESTIGATOR
References: