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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day
Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day. They may be administered in combination as 50/25 mg/day tablets (Juluca 50/25) or separately as Dolutegravir 50 mg/d tablets together with Rilpivirine 25 mg/d tablets (Tivicay 50 + Edurant 25)
干预措施: Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day (Drug)
TDF 245 mg /day or TAF 25 mg /day + FTC 200 mg /day + RPV 25 mg / day
Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabina (FTC) 200 mg/d + Rilpivirina (RPV) 25 mg/d. They may be administered as single tablets (EVIPLERA 200 mg/25 mg/245 mg) or in combination forms where one tablet contains TDF/TAF and FTC and another RPV tablet (TDF/FTC + Edurant 25 or Descovy 25/200 + Edurant 25)
干预措施: 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 (Drug)
Continue with their previous treatment. Any previous HAART does not contain RILPIVIRINE.
Patients who are randomised to this treatment arm will continue with the HAART they were receiving prior to signing the informed consent. As in arms 1 and 2, a change in the form of HAART administration (from a combined to a separate form and vice versa) will be allowed as long as the HAART components are respected.
干预措施: Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine. (Drug)
结局指标
主要结局
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
时间窗: 18 months
Reduction in liver stiffness measured by ET or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group.
次要结局
- Efficacy of RPV in reducing liver fibrosis of any grade(12-18 months)
- To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis(12-18 months)
- To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance(12-18 months)
- To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism(12-18 months)
- To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation(12-18 months)
- To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation.(12-18 months)
- Efficacy of RPV to reduce hepatic steatosis/fibrosis.(18 months)
- To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells(18 months)
- Efficacy of RPV to reduce the progression to steatohepatitis(18 months)