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

Study Overview
=================
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.

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

Conditions
-----------------
Hiv

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients who received a doravirine-based regimen. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 | 
| Tolerability rate of study patients. | Number of interactions, adverse events and toxicities. | Up to 48 weeks. | 
| Death rates among trial patients. | Number of patients who died during or after the trial. | Up to 48 weeks. |