Yükleniyor... / Loading...
This study evaluated the efficacy and safety of a Rilpivirine-based antiretroviral treatment regimen in people with HIV who have an undetectable viral load and metabolic liver disease such as fatty liver. It included patients over 18 who had never taken Rilpivirine and had been on stable treatment for at least 6 months. It was conducted in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.