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Can a phone app help people with HIV beat fatty liver disease?

NCT ID NCT07456332

Symptom relief Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a mobile app-based nutritional program can help people living with HIV and fatty liver disease lose at least 5% of their body weight in 6 months. Participants are randomly assigned to use the app or receive standard lifestyle advice. The goal is to find a practical, low-cost way to improve liver health and overall well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digital nutritional program (mobile app)
What this could lead to
If successful, this could provide a simple, scalable tool to help people with HIV manage weight and reduce liver fat, improving overall health.
What could go wrong
This is a small, early-stage study with no blinding, and results depend on participants sticking with the app. Weight loss may be modest or not sustained long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-infected patients * ≥ 18 years of age * On stable antiretroviral therapy during the last 6 months * HIV viral load \<50 copies/ml for ≥ 6 months * CD4 cell count \>200 cells/uL * Diagnosis of liver steatosis on ultrasound or Controlled Attenuation Parameter (CAP) measured by vibration-controlled transient elastography Exclusion Criteria: * Body mass index ≤ 23 kg/m2 * Presence of a condition that precluded modification of activity or diet behaviour * Known liver disease other tan MASLD including viral, haemochromatosis, Wilson's Disease, alpha-1 antitripsin deficiency, autoimmune hepatitis and cirrhosis * Excessive alcohol consumption (\>15 gr/day for women and 30 gr/day for men), * Endocrine disorders: hyperthyroidism or uncontrolled hypothyroidism * Pharmacological treatment with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis (amiodarone, tamoxifen, methotrexate) or alter liver tests * The use of weight modifiers or previous weight loss surgery at any time * Cardiovascular event in the last 6 months * Stage 4 and above kidney disease * Active infection, cancer or autoimmune disease * Inability to use an internet application or not having a Smartphone, * Low command of spanish or illiteracy, * Refusal to give informed consent * Pregnant women or women planning pregnancy

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Conditions

The condition(s) this trial relates to.

HIV infectious disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Life style Metabolic dysfunction-associated steatotic liver disease People living with HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.