A Phase 4 interventional study of Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day and 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 in HIV Infections and Fatty Liver Disease, sponsored by Fundacion SEIMC-GESIDA. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Fundacion SEIMC-GESIDA · Phase 4, Interventional, and Treatment
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 63 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Drug page: Dolutegravir
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.
Drug page: Tenofovir alafenamide
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.
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.
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.
Time frame: 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.
Time frame: 18 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Dolutegravir · Tenofovir alafenamide
Fundacion SEIMC-GESIDA