HIV InfectionsPhase 4MAFALDA-RNCT05898841
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
A Phase 4 study testing 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 day and Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine. in people with HIV Infections and Fatty Liver Disease, run by Fundacion SEIMC-GESIDA at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Fatty Liver Disease
- What is being tested?
- 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 day and Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesSpain
- Study dates
- 26 May 2023to 7 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Prior history of Rilpivirine use of any duration.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario Gregorio Marañon
Madrid
Hospital universitario Infanta Leonor
Madrid
Hospital Universitario Infanta Sofía
Madrid
Hospital Universitario La Paz
Madrid
About this study
Official title: 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
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.
- Conditions
- HIV Infections, Fatty Liver Disease
- Being tested
- 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 day, Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.
- Medical subject headings
- HIV Infections, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: Drug: Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (37)
Efficacy of RPV in reducing liver fibrosis of any grade
To evaluate the efficacy of RPV in reducing liver fibrosis of any grade, as measured by non-invasive tests, in HIV-infected people:
- as part of a nucleoside analogue-free antiretroviral treatment regimen
- as part of an antiretroviral treatment regimen that includes tenofovir
Proportion of subjects with ET measurement < 5.2 kPa in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
Proportion of subjects with a FIB4 measurement < 1.3 in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
The mean reduction in the APRI measure in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
Proportion of subjects with an APRI measure < 0.5 in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction in the percentage of liver fat, measured by magnetic resonance imaging, which measures the proton density fraction of fat (MRI-PDFF), between the beginning and the end of the study comparing the intervention group (arms 1 and 2) vs control group
Measured: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Difference in the proportion of responders between the intervention group (arms 1 and 2) at 18 months from the start of treatment, defined as those who achieve >30% reduction in hepatic steatosis measured by MRI-PDFF
Measured: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Proportion of subjects with hepatic steatosis measured as MRI-PDFF > 5% steatosis in the intervention group (arms 1 and 2) compared to the control group at 18 months from the start of treatment
Measured: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction of the CAP measurement in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction in the FLI measurement in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction in the HSI measure in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction of the TyG measurement in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Proportion of subjects with hepatic steatosis measured as CAP > 238 dB/m in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
The mean reduction in the FLI measurement in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Proportion of subjects with hepatic steatosis measured as HSI score > 36 in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Proportion of subjects with hepatic steatosis measured as TyG score > 8.38 in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
The mean reduction of the HOMA-IR value in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Difference in the proportion of subjects with insulin resistance, measured as HOMA-IR >2.5 in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Mean reduction in TyG (IR) measurement in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Difference in the proportion of subjects with insulin resistance measured as TyG > 4.68 in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
The mean reduction in fasting blood glucose (mg/dL) in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Difference in the proportion of subjects with fasting glycemia > 100 mg/dL in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
The reduction in the measurement of abdominal circumference and waist ratio/in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatmen
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
The mean reduction in fasting triglycerides (mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Difference in the proportion of subjects with hypertriglyceridemia (value > 150 mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Mean reduction in fasting LDL cholesterol quantification (mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Difference in the proportion of subjects with elevated LDL cholesterol (value > 130 mg/dL and value >100 mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months of start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
The mean increase in fasting HDL cholesterol quantification (mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Difference in the proportion of subjects with elevated HDL cholesterol (value > 45 mg/dL in men and value > 50 mg/dL in women) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months from the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
The mean reduction in fasting non-LDL cholesterol quantification (mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment.
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Difference in the proportion of subjects with elevated non-LDL cholesterol (value > 160 mg/dL) in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months after the start of treatment
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
The mean change in ALT value (IU/mL) in the intervention group (arms 1 and 2) vs. the control group at 12 and 18 months from baseline
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
The mean change in AST value (IU/mL) in the intervention group (arms 1 and 2) versus the control group at 12 and 18 months from the baseline visit
Measured: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation.
The change of the gene expression value of: IL1-beta, IL6, IL10, MCP1, PAI-1, TGF-alpha, TNF-alpha in PBMCs in the intervention group (arms 1 and 2) compared to the control group at 12 and 18 months compared to the baseline visit.
Measured: 12-18 months
Efficacy of RPV to reduce hepatic steatosis/fibrosis.
To assess the efficacy of RPV as part of the antiretroviral treatment regimen in HIV-infected individuals to reduce hepatic steatosis/fibrosis based on the presence of PNPLA3 and MBOAT7-TMC4 genetic polymorphisms.
Measured: 18 months
To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
. Analyse the gene expression of inflammatory and fibrogenic markers in peripheral blood polymorphonuclear cells by RT-PCR: IL1-gamma, IL6, IL10, MCP1, P AI-1, TGF-beta, TNF-alpha.
Measured: 18 months
To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
. Measurement of ALT, AST and GGT in plasma as markers of inflammation.
Measured: 18 months
Efficacy of RPV to reduce the progression to steatohepatitis
In previous studies it has shown that PNPLA3, TM6SF2, and MBOAT7-TMC4 polymorphisms are associated with elevated ALT levels and histologic parameters of nonalcoholic steatohepatitis and fibrosis severity.
On the baseline visit will be collected biological samples for genetuic study. A 3 ml blood sample will be drawn into an EDTA tube at baseline visit for determination of PNPLA3 (C, G alleles) and MBOAT7-TMC4 (G, A alleles) genetic polymorphisms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start26 May 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898841
- Sponsor's protocol ID
- GESIDA 12422
- Acronym
- MAFALDA-R
- Status last verified
- Jul 2025
- First submitted
- 5 Apr 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05898841
- Acronym / sponsor ID
- MAFALDA-R / GESIDA 12422
- Conditions
- HIV Infections, Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day | Experimental | Drug: Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per dayDolutegravir (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) |
| TDF 245 mg /day or TAF 25 mg /day + FTC 200 mg /day + RPV 25 mg / day | Experimental | 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 dayTenofovir 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) |
| Continue with their previous treatment. Any previous HAART does not contain RILPIVIRINE. | Active comparator | Drug: Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per dayDTG/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. | Drug | 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 dayTDF 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. | Drug | 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.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 does not contain RILPIVIRINE. |
Primary outcome
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
Time frame: 18 months
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.
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
Time frame: 18 months
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.
37 secondary outcomes
Efficacy of RPV in reducing liver fibrosis of any grade
Time frame: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
Time frame: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
Time frame: 12-18 months
Efficacy of RPV in reducing liver fibrosis of any grade
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to reduce hepatic steatosis
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the insulin resistance
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to improve the lipid metabolism
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation
Time frame: 12-18 months
To evaluate the efficacy of Rilpivirine (RPV) to decrease the liver inflammation.
Time frame: 12-18 months
Efficacy of RPV to reduce hepatic steatosis/fibrosis.
Time frame: 18 months
To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
Time frame: 18 months
To characterise the effects of RPV on the expression of inflammatory and fibrogenic markers in peripheral blood mononuclear cells
Time frame: 18 months
Efficacy of RPV to reduce the progression to steatohepatitis
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 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 day and Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine. in people with HIV Infections and Fatty Liver Disease, run by Fundacion SEIMC-GESIDA at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.