NCT05898841CompletedPhase 4
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load
An Open Label, Comparative, Randomized , Phase IV Pilot Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
In HIV-infected people with metabolic fatty liver disease and liver fibrosis of any degree, as measured by non-invasive testing, antiretroviral treatment that includes rilpivinire for 18 months results in a slowing of progression and/or reduction of fatty metabolic liver disease, attenuating inflammation and liver fibrosis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 5 Apr 2023
- Start date
- 26 May 2023
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Diseases
- HIV, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05898841
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 63
- From 26 May 2023 to the primary completion date, 7 Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not having received more than three previous lines of antiretroviral treatment
- Have diabetes mellitus on treatment with SGLT2, GLP1 or plioglitazone of less than 6 months duration.
- Any previous physical or mental condition (such as habitual drug use) that the investigator believes may interfere with the patient's ability to comply with the study protocol.
- Prior history of Rilpivirine use of any duration.
Other illness
- Have an HIV viral load \< 50 copies/ml for at least the last 6 months, 1 blip below 500 copies/ml is allowed during this period.
- Have an ultrasound-diagnosed fatty liver metabolic disease or a CAP (Controlled Attenuation Parameter®) measurement \> 238 dB/m with an IQR \< 30 dB/m.
- Have an fatty liver metabolic disease with some degree of fibrosis diagnosed by ET (Fibroscan®) \> 5.2 kPa. In patients in whom ET is not possible, have a FIB-4 \>1.3.
- Have chronic HBV infection (presence of HBsAg+) or HCV (detectable HCV viral load). Patients with past treated HCV are also not allowed to be included (does not include patients with spontaneously resolved HCV infection).
- Have a history of alcohol abuse
- Have chronic decompensated liver disease, defined as any of the following: presence of encephalopathy, ascites, coagulopathy, oesophageal or gastric varices, or persistent jaundice.
Other
- No resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF) or Emtricitabine.
- Be able to understand and comply with the requirements and instructions of the protocol.
- Understanding long-term commitment to study
- Acceptance of their participation in the study by signing an informed consent form.
- Harmful alcohol consumption, defined as \>30 grams of alcohol per day in men and \>20 grams of alcohol per day in women.
- Pregnancy or breastfeeding at the screening visit or at any time during the study or intention to become pregnant during the study period.
Who the study is looking for
- Patients over 18 years of age with HIV infection who have never received antiretroviral treatment with Rilpivirine.
- Have a stable ART pattern for at least the last 6 month
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.