drugset / Trial / NCT05898841

Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load

NCT05898841

Phase 4 Completed 63 enrolled Fundacion SEIMC-GESIDA
RandomizedParallel-groupOpen-labelTreatment

Summary

In HIV-infected people with metabolic fatty liver disease and liver fibrosis of any degree, as measured by non-invasive testing, antiretroviral treatment that includes rilpivinire for 18 months results in a slowing of progression and/or reduction of fatty metabolic liver disease, attenuating inflammation and liver fibrosis.

Timeline

Start
2023-05-26
Primary completion
2025-07-07
Completion
2025-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg
Subject Rilpivirine Small molecule 25 mg
Subject Tenofovir disoproxil fumarate Small molecule 245 mg
Subject emtricitabine Other / unclassified 200 mg
Subject tenofovir alafenamide Small molecule 25 mg