Phase
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
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Hospital Universitario Gregorio Marañon
Madrid,
SpainSite Not Available
Hospital Universitario Infanta Sofía
Madrid,
SpainSite Not Available
Hospital Universitario La Paz
Madrid,
SpainSite Not Available
Hospital universitario Infanta Leonor
Madrid,
SpainSite Not Available
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