Impact of Doravirine in Liver Steatosis and Fibrosis in PLWH. A pilot, proof of concept study (DORALI Study)
Phase 1
- Conditions
- Human Immunodeficiency VirusTherapeutic area: Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504952-87-00
- Lead Sponsor
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Eligible subjects need to present some degree of liver steatosis (Fibroscan: >=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa).
Exclusion Criteria
Any evidence of current or previous Hepatitis B or C [Active Surface Hepatitis B Ag (HBAgS) OR negative HBAgS and negative hepatitis B surface antibody (anti-HBs) with positive anti-core antibody (anti-HBc) and positive HBV DNA. Hepatitis C IgG positive]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine changes in liver steatosis measured by CAP (Controlled Attenuation Parameter, expressed in db/m) and liver fibrosis measured by transient elastography (expressed in Kpa) in HIV asymptomatic individuals who present with some degree of confirmed liver steatosis (>=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa) who switch to a regimen based in Doravirine. Changes in HIV general outcomes as well as metabolic results will be evaluated at baseline and week 48.;Secondary Objective: Determine changes in fat liver content by MRI in a subset of 40 PLWH included in the study who change to a regimen based in Doravirine., Determine changes in lipoprotein particles at week 48.;Primary end point(s): Liver steatosis measured and liver fibrosis measured by CAP (Controlled Attenuation-Parameter, expressed in db/m) and transient elastography respectively
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Fat liver content by MRI;Secondary end point(s):Lipoprotein particles at week 48