Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07456332
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07456332
Study Brief:
Protocol Section:
NCT07456332