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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Treatments: Dolutegravir; Emtricitabine; Rilpivirine; Tenofovir

Criteria

Inclusion Criteria:

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

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

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 (Controlled Attenuation 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 the protocol.

• 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 include patients with spontaneously resolved HCV infection).

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

• Have a history of alcohol abuse

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

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

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

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

• Prior history of Rilpivirine use of any duration.