NCT05898841

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started May 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

April 5, 2023

Last Update Submit

July 17, 2025

Conditions

HIV InfectionsFatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in VIH-infected people, to slow the progression and/or reduce liver fibrosis of any degree

    To measure the no progression and/or regression of liver fibrosis: No change in liver stiffness as measured by ET (Transient Elastography) or FIB4 at the 18-month visit with respect to the baseline, the intervention group (branches 1 and 2) compared to the control group.

    18 months

  • To evaluate the efficacy of Rilpivirine (RPV) as part of the antiretroviral treatment regimen in VIH-infected people, to slow the progression and/or reduce liver fibrosis of any degree

    Reduction in liver stiffness measured by ET or FIB4 at the 18-month visit from baseline in the intervention group (arms 1 and 2) versus the control group.

    18 months

Secondary Outcomes (37)

  • Efficacy of RPV in reducing liver fibrosis of any grade

    12-18 months

  • Efficacy of RPV in reducing liver fibrosis of any grade

    12-18 months

  • Efficacy of RPV in reducing liver fibrosis of any grade

    12-18 months

  • Efficacy of RPV in reducing liver fibrosis of any grade

    12-18 months

  • To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis

    18 months

  • +32 more secondary outcomes

Study Arms (3)

Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day

EXPERIMENTAL

Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day. They may be administered in combination as 50/25 mg/day tablets (Juluca 50/25) or separately as Dolutegravir 50 mg/d tablets together with Rilpivirine 25 mg/d tablets (Tivicay 50 + Edurant 25)

Drug: Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day

TDF 245 mg /day or TAF 25 mg /day + FTC 200 mg /day + RPV 25 mg / day

EXPERIMENTAL

Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabina (FTC) 200 mg/d + Rilpivirina (RPV) 25 mg/d. They may be administered as single tablets (EVIPLERA 200 mg/25 mg/245 mg) or in combination forms where one tablet contains TDF/TAF and FTC and another RPV tablet (TDF/FTC + Edurant 25 or Descovy 25/200 + Edurant 25)

Drug: Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabine (FTC) 200 mg per day + Rilpivirine 25 mg per day

Continue with their previous treatment. Any previous HAART does not contain RILPIVIRINE.

ACTIVE COMPARATOR

Patients who are randomised to this treatment arm will continue with the HAART they were receiving prior to signing the informed consent. As in arms 1 and 2, a change in the form of HAART administration (from a combined to a separate form and vice versa) will be allowed as long as the HAART components are respected.

Drug: Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.

Interventions

Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per dayDRUG

DTG/RPV will be administered in combination as 50/25 mg/day tablets or separately as DTG 50 mg/d tablets together with RPV 25 mg/d tablets. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART (Highly Active Antiretroviral Therapy) components are respected.

Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day
Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabine (FTC) 200 mg per day + Rilpivirine 25 mg per dayDRUG

TDF 245 mg/d or TAF 25mg/d together with FTC 200 mg/d and RPV 25 mg/d. They may be administered as single tablets or in combination forms where one tablet contains TDF/TAF and FTC and another RPV tablet. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART components are respected.

TDF 245 mg /day or TAF 25 mg /day + FTC 200 mg /day + RPV 25 mg / day
Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.DRUG

Patients who are randomised to this treatment arm will continue with the HAART they were receiving prior to signing the informed consent. As in arms 1 and 2, a change in the form of HAART administration (from a combined to a separate form and vice versa) will be allowed as long as the HAART components are respected.

Continue with their previous treatment. Any previous HAART does not contain RILPIVIRINE.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not having received more than three previous lines of antiretroviral treatment
  • No resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF) or Emtricitabine.
  • 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.
  • 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.
  • 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 diabetes mellitus on treatment with SGLT2, GLP1 or plioglitazone of less than 6 months duration.
  • Have a history of alcohol abuse
  • Harmful alcohol consumption, defined as \>30 grams of alcohol per day in men and \>20 grams of alcohol per day in women.
  • Have chronic decompensated liver disease, defined as any of the following: presence of encephalopathy, ascites, coagulopathy, oesophageal or gastric varices, or persistent jaundice.
  • 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.
  • Pregnancy or breastfeeding at the screening visit or at any time during the study or intention to become pregnant during the study period.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario Gregorio Marañon

Madrid, Spain

Location

Hospital universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Infanta Sofía

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

HIV InfectionsNon-alcoholic Fatty Liver Disease

Interventions

dolutegravirRilpivirineTenofovirtenofovir alafenamideEmtricitabineRacivir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOrganophosphonatesOrganophosphorus CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

June 12, 2023

Study Start

May 26, 2023

Primary Completion

July 7, 2025

Study Completion

July 7, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

ES(4)