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Impact of Doravirine in Liver Steatosis and Fibrosis in PLWH. A pilot, proof of concept study (DORALI Study)
EU CTIS ID: 2023-504952-87-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eligible subjects need to present some degree of liver steatosis (Fibroscan: >=S1-238 a 260 dB/m) or liver fibrosis (>=F2->7Kpa).
You likely can't join if
- 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]
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.