Status:
COMPLETED
Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Merck Sharp & Dohme LLC
CIHR Canadian HIV Trials Network
Conditions:
HIV
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
HIV infection exerts a negative impact on the course of HCV infection. Co-infected individuals progress more rapidly to liver fibrosis, cirrhosis and ESLD compared to those infected with HCV alone. So...
Detailed Description
Primary Objective-To assess if switching from ritonavir boosted-PI based ART regimen to a Raltegravir-based regimen will reduce the rate of hepatic fibrosis progression in HIV-HCV co-infected patients...
Eligibility Criteria
Inclusion
- 18 years or older
- Chronic HIV-HCV co-infection (HCV RNA + for at least 6 months and could have had previous HCV treatment).
- Receiving ritonavir boosted PI-based ART for at least 6 months.
- APRI score ≥ 1.5 (equivalent to liver biopsy score of ≥ F2) AND/OR Fibroscan \> 6.9KPa
- HIV viral suppression (\<50 copies/mL) for at least 6 months.
- No prior evidence of resistance to raltegravir or co-administered nucleoside backbone.
- No prior history of virologic failure.
Exclusion
- Clinical evidence of decompensated liver disease (e.g., ascites, esophageal varices, or hepatic encephalopathy hepatoma or hepatocellular carcinoma).
- Chronic Hepatitis B infection (defined as positive HBsAg or Hepatitis B viral load greater than 10,000 copies/mL).
- 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 (WOCBP 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).
- Patients intending to start HCV therapy within the treatment phase (within the year following the baseline visit).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01231685
Start Date
December 1 2011
End Date
September 1 2016
Last Update
September 21 2016
Active Locations (3)
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1
Providence Health Care- St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
University Health Network - Toronto General Hospital Division
Toronto, Ontario, Canada, M5G2N2
3
Montreal Chest Institute
Montreal, Quebec, Canada