Phase IV comparative, randomized, open-label pilot study to evaluate the efficacy and safety of a rilpivirine-based antiretroviral treatment regimen in HIV-infected patients with metabolic liver disease who maintain undetectable HIV viral load
Key facts
- Where
- Madrid és San Sebastián de los Reyes, SpanyolországSee the 4 sites
- Phase
- 4. fázis
Where in Spanyolország
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario Infanta LeonorMadrid, SpanyolországNo longer taking part
- Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
- Hospital Universitario Infanta SofiaSan Sebastián de los Reyes, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Seimc Gesida
- Trial code
- EU 2022-503110-23-00
- Record updated
- 2023. augusztus 28.
- Original description
To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in HIV-infected people, to slow the progression and/or reduce liver fibrosis of any degree, measured by non-invasive testsRead full original descriptionShow less
To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in HIV-infected people, to slow the progression and/or reduce liver fibrosis of any degree, measured by non-invasive tests
Inclusion: Patients over 18 years of age with HIV infection who have never received antiretroviral treatment with Rilpivirine. 2. Have a stable ART regimen for at least the last 6 months. Simplifications to combination therapies will not be taken into account as long as the patient has a control of the HIV viral load after the change that confirms its undetectability. 3. Not have resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF) or Emtricitabine. 4. Have an HIV viral load < 50 copies/ml for at least the last 6 months, 1 blip less than 500 copies/ml is allowed during this period. 5. Having an EHMG diagnosed by ultrasound or a CAP measurement (Controlled Attenuation Parameter®) > 238 dB/m with an IQR < 30 dB/m. 6. Having an EHMG with some degree of fibrosis diagnosed by ET (Fibroscan®) > 5.2 kPa (the use of a Fibroscan® performed by usual clinical practice in the 3 months prior to the screening visit will be allowed). In patients in whom ET is not possible, have a FIB-4 >1.3. 7. Be able to understand and comply with the requirements and instructions of the protocol 8. Understand the long-term commitment to the study 9. Acceptance of your participation in the study by signing an informed consent.
Exclusion: Having a chronic HBV infection (presence of HBsAg+) or HCV (detectable HCV viral load). The inclusion of patients with: • HCV treated and cured before 12/31/2019 whose liver stiffness measured by Fibroscan® was not greater than 9 kPa when they had active HCV infection. • HCV infection resolved spontaneously. 2. Having diabetes mellitus under treatment with SGLT2, GLP1 or plioglitazone for less than 6 months. 3. Have a history of alcohol abuse 4. Having a harmful consumption of alcohol, defined as >30 g of alcohol per day in men and more than >20 g of alcohol per day in women. 5. Having chronic decompensated liver disease, defined as any of the following: presence of encephalopathy, ascites, coagulopathy, esophageal or gastric varices, or persistent jaundice. 6. Any prior 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 7. Pregnant or lactating at the screening visit or at any time during the study or intent to become pregnant during the study period. 8. Previous history of rilpivirine use of any duration.