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

Hiv Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05140603
• Other study ID #: FIS-DOR-2021-01
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Nuria Espinosa Aguilera
• Phone: 955 01 30 98
• Email: nuriai.espinosa.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 1, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with an HIV-1 viral load = 50 and = 200* copies/ml using snapshot algorithm.	FDA snapshot algorithm (ITT-exposed).	Up to 96 weeks.
Secondary	Rate of changes in renal biomarkers.	Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks.	Up to 48 weeks.
Secondary	Rate of changes in hepatic parameters.	Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin).	Up to 48 weeks.
Secondary	Rate of changes in lipid parameters.	Changes in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio.	Up to 48 weeks
Secondary	Tolerability rate of study patients.	Number of interactions, adverse events and toxicities.	Up to 48 weeks.
Secondary	Death rates among trial patients.	Number of patients who died during or after the trial.	Up to 48 weeks.