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

Phase 4

• 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

• Registration Number: TCTR20210403003
• Lead Sponsor: Thai AIDs Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-03
• Study Completion: 2021-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 54

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of controlled attention parameter 24 weeks after randomization fibroscan

Secondary Outcome Measures

Name	Time	Method
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