Clinical trial NCT05898841: 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
Official title: An Open Label, Comparative, Randomized , Phase IV Pilot 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV Infections
Fatty Liver Disease
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in VIH-infected people, to slow the progression and/or reduce liver fibrosis of any degree
timeFrame: 18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in VIH-infected people, to slow the progression and/or reduce liver fibrosis of any degree
timeFrame: 18 months
Secondary outcomes:
measure: Efficacy of RPV in reducing liver fibrosis of any grade
timeFrame: 12-18 months
measure: Efficacy of RPV in reducing liver fibrosis of any grade
timeFrame: 12-18 months
measure: Efficacy of RPV in reducing liver fibrosis of any grade
timeFrame: 12-18 months
measure: Efficacy of RPV in reducing liver fibrosis of any grade
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
timeFrame: 12-18 months
measure: To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation.
timeFrame: 12-18 months
measure: Efficacy of RPV to reduce hepatic steatosis/fibrosis.
timeFrame: 18 months
measure: To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
timeFrame: 18 months
measure: To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
timeFrame: 18 months
measure: Efficacy of RPV to reduce the progression to steatohepatitis
timeFrame: 18 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: