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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
Bu çalışma, HIV enfeksiyonu olan ve viral yükü kontrol altında (saptanamaz düzeyde) olan, karaciğer yağlanması (fatty liver) gibi metabolik karaciğer hastalığı bulunan hastalarda Rilpivirine temelli antiretroviral tedavi rejiminin etkinliğini ve güvenliğini değerlendirmektedir. Çalışmaya, daha önce Rilpivirine kullanmamış ve en az 6 aydır stabil tedavi gören 18 yaş üzeri hastalar dahil edilmiştir. Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.