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

Last updated: July 17, 2025
Sponsor: Fundacion SEIMC-GESIDA
Overall Status: Completed

Phase

4

Condition

Primary Biliary Cholangitis

Hiv Infections

Nonalcoholic Steatohepatitis (Nash)

Treatment

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

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

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

Clinical Study ID

NCT05898841
GESIDA 12422
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age with HIV infection who have never receivedantiretroviral treatment with Rilpivirine.

  • Have a stable ART pattern for at least the last 6 month

Exclusion

Exclusion Criteria:

  • Not having received more than three previous lines of antiretroviral treatment

  • No resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir,Tenofovir (TDF and/or TAF) or Emtricitabine.

  • Have an HIV viral load < 50 copies/ml for at least the last 6 months, 1 blip below 500 copies/ml is allowed during this period.

  • Have an ultrasound-diagnosed fatty liver metabolic disease or a CAP (ControlledAttenuation Parameter®) measurement > 238 dB/m with an IQR < 30 dB/m.

  • Have an fatty liver metabolic disease with some degree of fibrosis diagnosed by ET (Fibroscan®) > 5.2 kPa. In patients in whom ET is not possible, have a FIB-4 >1.3.

  • Be able to understand and comply with the requirements and instructions of theprotocol.

  • Understanding long-term commitment to study

  • Acceptance of their participation in the study by signing an informed consent form.

Exclusion Criteria:

  • Have chronic HBV infection (presence of HBsAg+) or HCV (detectable HCV viral load).Patients with past treated HCV are also not allowed to be included (does not includepatients with spontaneously resolved HCV infection).

  • Have diabetes mellitus on treatment with SGLT2, GLP1 or plioglitazone of less than 6months duration.

  • Have a history of alcohol abuse

  • Harmful alcohol consumption, defined as >30 grams of alcohol per day in men and >20grams of alcohol per day in women.

  • Have chronic decompensated liver disease, defined as any of the following: presenceof encephalopathy, ascites, coagulopathy, oesophageal or gastric varices, orpersistent jaundice.

  • Any previous physical or mental condition (such as habitual drug use) that theinvestigator believes may interfere with the patient's ability to comply with thestudy protocol.

  • Pregnancy or breastfeeding at the screening visit or at any time during the study orintention to become pregnant during the study period.

  • Prior history of Rilpivirine use of any duration.

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.
Phase: 4
Study Start date:
May 26, 2023
Estimated Completion Date:
July 07, 2025

Connect with a study center

  • Hospital Universitario Gregorio Marañon

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Infanta Sofía

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital universitario Infanta Leonor

    Madrid,
    Spain

    Site Not Available

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