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Study on the Effects of Doravirine on Liver Health in People Living with HIV with Liver Steatosis or Fibrosis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Doravirine on liver conditions in people living with Human Immunodeficiency Virus (HIV). The study aims to explore how Doravirine impacts liver steatosis, which is a condition where fat builds up in the liver, and liver fibrosis, which involves the thickening and scarring of liver tissue. Participants in the study will switch to a treatment regimen that includes Doravirine to observe any changes in these liver conditions.

The study will involve taking film-coated tablets of Doravirine, and it will also compare the effects of other medications such as Biktarvy, Descovy, Delstrigo, and Pifeltro. These medications contain active substances like Emtricitabine, Tenofovir Alafenamide, Bictegravir, LAMIVUDINE, Doravirine, and Tenofovir Disoproxil. The purpose of the study is to determine how these treatments affect liver health and overall HIV outcomes over a period of 48 weeks.

Participants will undergo assessments at the start of the study and again at the end of the 48-week period. These assessments will include measuring liver steatosis and fibrosis using a method called transient elastography, which helps evaluate liver stiffness. Additionally, changes in fat content in the liver will be checked using MRI scans, and lipoprotein particles will be analyzed. The study is designed to provide insights into the potential benefits of Doravirine for liver health in individuals with HIV.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on the presence of liver steatosis or liver fibrosis. This is determined using a Fibroscan, which measures liver stiffness and fat content.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to measure liver steatosis and fibrosis. These measurements are taken using a Controlled Attenuation Parameter (CAP) and transient elastography. CAP is expressed in decibels per meter (dB/m), and elastography is expressed in kilopascals (Kpa).

  3. Step 3

    Medication regimen

    Participants switch to a medication regimen based on doravirine. This involves taking Pifeltro 100 mg film-coated tablets orally. The exact dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments are conducted to monitor changes in liver steatosis and fibrosis. These assessments occur at various intervals, including a significant evaluation at week 48.

  5. Step 5

    Secondary assessments

    Additional assessments include measuring fat liver content using MRI and evaluating lipoprotein particles at week 48.

  6. Step 6

    Study completion

    The study is estimated to conclude by May 31, 2025. Final assessments will be conducted to evaluate the impact of the medication regimen on liver health and other metabolic outcomes.

Who can join the trial?

6 criteria

  • The patient must have **HIV** (Human Immunodeficiency Virus).
  • The patient should have some degree of **liver steatosis**. This means there is a buildup of fat in the liver. It is measured using a test called **Fibroscan**, and the result should be between 238 and 260 dB/m.
  • The patient may also have **liver fibrosis**, which is a condition where the liver becomes scarred. This is also measured by Fibroscan, and the result should be greater than 7 Kpa.
  • The patient must be an adult, which means they should be at least 18 years old.
  • Both **men and women** can participate in the study.
  • The patient should not belong to a vulnerable population, which means they should not be in a group that needs special protection or care.

Who cannot join the trial?

5 criteria

  • Individuals who do not have a confirmed diagnosis of Human Immunodeficiency Virus (HIV) cannot participate. HIV is a virus that attacks the body's immune system.
  • Individuals who do not have some degree of confirmed liver steatosis or liver fibrosis cannot participate. Liver steatosis is a condition where there is too much fat in the liver, and liver fibrosis is a condition where there is scarring of the liver tissue.
  • Individuals who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both males and females are eligible, so individuals of other genders cannot participate.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.
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Investigated drugs

Doravirine is a medication used in this study to assess its impact on liver steatosis and fibrosis in people living with HIV. The study aims to determine if switching to a treatment regimen that includes **Doravirine** can lead to improvements in liver health, specifically by reducing liver fat and scarring. Participants in the trial are individuals with HIV who have been diagnosed with some level of liver steatosis or fibrosis. The effects of **Doravirine** on general HIV outcomes and metabolic health will also be evaluated over a 48-week period.

What is already known about the treatment

Doravirine – Doravirine is an oral medication used primarily in the treatment of Human Immunodeficiency Virus (HIV). It is currently being studied for its potential effects on liver steatosis and fibrosis in people living with HIV. The drug works by inhibiting the action of reverse transcriptase, an enzyme crucial for the replication of the virus, thereby reducing the viral load in the body. Doravirine is classified as a non-nucleoside reverse transcriptase inhibitor (NNRTI). This study aims to assess changes in liver health and overall HIV outcomes in patients switching to a Doravirine-based regimen.

Investigated diseases

Human Immunodeficiency Virus – This virus attacks the body's immune system, specifically the CD4 cells (T cells), which are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing injection drug equipment. In the early stages, many people may not experience symptoms, but as the virus progresses, it can lead to more severe health issues. Without treatment, HIV can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely damaged. However, with proper medical care, HIV can be controlled, and individuals can live long, healthy lives.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504952-87-00Protocol codeDORALIEstimated enrolment50 patientsSponsorFundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia

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