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Effect after Switching from Efavirenz to Rilpivirine on Liver Steatosis Among People Living with HIV with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Trial

Effect after Switching from Efavirenz to Rilpivirine on Liver Steatosis Among People Living with HIV with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210403003
Enrollment
54
Registered
2021-04-03
Start date
2021-05-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We aimed at comparing the impact of switching from efavirenz to rilpivirine in patients receiving efavirenz plus 2 nucleoside analogues versus continuing with the same therapy on hepatic steatosis as measured by controlled attenuation parameter (CAP) among HIV-infected patients with NAFLD. Efavirenz Rilpivirine Switching HIV NAFLD Fatty liver disease CAP

Interventions

The group that switched from efavirenz to rilpivirine was changed to the following antiretroviral drugs In the case of receiving 3 antiviral drugs and separate tablets for each type or two types of a
Active Comparator Drug,Active Comparator Drug
rilpivirine switching group,efavirenz continuous group

Sponsors

Thai AIDs Society
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. HIV-1 infected patient 2. Age >= 18-year-old 3. Efavirenz was given in combination with either Tenofovir or Abacavir, and either Emtricitabine or Lamivudine for more than 24 weeks. 4. HIV-viral load < 40 copies/mL for more than 24 weeks. 5. Hepatic steatosis when measured by Controlled attenuation parameter >= 248 dB / m. 6. History of drinking less than 30 grams of alcohol per day in men and less than 20 grams per day in women

Exclusion criteria

Exclusion criteria: 1. Pregnant patients 2. History of virologic failure or virologic resistance 3. History of opportunistic infections in the past 24 weeks 4. Patients with contraindications to rilpivirine, for example receiving all proton pump inhibitors. 5. Infected with hepatitis B virus or hepatitis C virus 6. BMI more than 30 Kg/m2 7. Patients using drugs corticosteroid, methotrexate, amiodarone, valproate 8. Patients diagnosed with autoimmune hepatitis, hemochromatosis, Wilson's disease

Design outcomes

Primary

MeasureTime frame
change of controlled attention parameter 24 weeks after randomization fibroscan

Secondary

MeasureTime frame
change of hepatic fibrosis 24 weeks after randomization fibroscan,Effect on metabolic conditions 24 week after randomization body weight, body mass index, waist circumference, Fasting blood sugar and lipid profile

Countries

Thailand

Contacts

Public ContactLaddarat Srikham

Infectious division, internal medicine department. King Chulalongkorn Memorial Hospital

laddarat.s20@chula.md0847979605

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026