Status:
COMPLETED
Raltegravir-based Antiretroviral Versus Maintaining Any Other Antiretroviral Therapy in HIV Mono-infected Patients
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
People infected with HIV are living longer thanks to the use of antiretroviral therapy (cART). In aging HIV persons, other factors are associated with early death. One of the major factors is liver di...
Detailed Description
Current Non-invasive tools for liver fibrosis and fatty liver/NASH, including Fibroscan/CAP and serum cytokeratin 18 (CK-18), are accurate and ideal for screening and monitoring. To date, there has be...
Eligibility Criteria
Inclusion
- 18 years or older
- Confirmed positive serology for HIV mono-infection
- Valid Fibroscan/CAP results
- Able to provide informed consent (available in French or English)
- Receiving any approved antiretroviral regimen that does not contain integrase-inhibitor
- Evidence of fatty liver (CAP\>237.8dB/m) AND/OR evidence of significant liver fibrosis (Fibroscan \> 8KPa)
- HIV viral suppression (\<50 copies/mL) for at least 6 months
- No prior evidence of resistance to raltegravir or co-administered nucleoside backbone
Exclusion
- Clinical evidence of decompensated liver disease at entry (e.g. ascites, bleeding esophageal varices, hepatic encephalopathy, or hepatoma/ hepatocellular carcinoma).
- Co-infection with hepatitis C virus (HCV) or hepatitis C virus (HBV) (presence of serum HCV-Ab or HBsAg);
- Alpha-fetoprotein (AFP) greater than or equal to 200 ng/mL at screening.
- Known or suspected Wilson's disease, alpha-1-antitrypsin deficiency, celiac disease or other cause of chronic liver disease.
- Chronic renal insufficiency (eGFR \< 20 mL/min) at screening.
- Pregnancy and planned pregnancy (not using adequate contraception).
- Women who are breastfeeding.
- Active opportunistic infection (except oral thrush) or neoplasm (except Kaposi's sarcoma, skin cancer, or cancer of the cervix or anus, unless known or suspected liver metastasis).
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02210715
Start Date
March 1 2015
End Date
January 30 2023
Last Update
October 19 2023
Active Locations (1)
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1
McGill University Health Center
Montreal, Quebec, Canada