Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Hiv

Study type: Observational

Funder types: Other

Identifiers

NCT05140603

FIS-DOR-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Cases

Description:

Patients who received a doravirine-based regimen.