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

PHASE4CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 26, 2023

Primary Completion Date

July 7, 2025

Study Completion Date

July 7, 2025

Conditions
HIV InfectionsFatty Liver Disease
Interventions
DRUG

Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day

DTG/RPV will be administered in combination as 50/25 mg/day tablets or separately as DTG 50 mg/d tablets together with RPV 25 mg/d tablets. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART (Highly Active Antiretroviral Therapy) components are respected.

DRUG

Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabine (FTC) 200 mg per day + Rilpivirine 25 mg per day

TDF 245 mg/d or TAF 25mg/d together with FTC 200 mg/d and RPV 25 mg/d. They may be administered as single tablets or in combination forms where one tablet contains TDF/TAF and FTC and another RPV tablet. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART components are respected.

DRUG

Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.

Patients who are randomised to this treatment arm will continue with the HAART they were receiving prior to signing the informed consent. As in arms 1 and 2, a change in the form of HAART administration (from a combined to a separate form and vice versa) will be allowed as long as the HAART components are respected.

Trial Locations (4)

Unknown

Hospital Universitario Gregorio Marañon, Madrid

Hospital universitario Infanta Leonor, Madrid

Hospital Universitario Infanta Sofía, Madrid

Hospital Universitario La Paz, Madrid

All Listed Sponsors
lead

Fundacion SEIMC-GESIDA

OTHER

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 | Biotech Hunter | Biotech Hunter