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

• Conditions: Hiv

• Registration Number: NCT05140603
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study Start: 2021-12-01
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.	Up to 96 weeks.	FDA snapshot algorithm (ITT-exposed).

Secondary Outcome Measures

Name	Time	Method
Rate of changes in renal biomarkers.	Up to 48 weeks.	Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks.
Tolerability rate of study patients.	Up to 48 weeks.	Number of interactions, adverse events and toxicities.
Rate of changes in hepatic parameters.	Up to 48 weeks.	Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin).
Rate of changes in lipid parameters.	Up to 48 weeks	Changes in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio.
Death rates among trial patients.	Up to 48 weeks.	Number of patients who died during or after the trial.

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain