Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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. Some of the this accelerated fibrosis may be related to longterm chronic toxicity from protease inhibitor based ART.

Hypothesis: 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 as measured by transient elastography (Fibroscan®) and the AST-to-platelet ratio index (APRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: CIHR Canadian HIV Trials Network; Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Darunavir; HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

1. 18 years or older

2. Chronic HIV-HCV co-infection (HCV RNA + for at least 6 months and could have had previous HCV treatment).

3. Receiving ritonavir boosted PI-based ART for at least 6 months.

4. APRI score ≥ 1.5 (equivalent to liver biopsy score of ≥ F2) AND/OR Fibroscan > 6.9KPa

5. HIV viral suppression (<50 copies/mL) for at least 6 months.

6. No prior evidence of resistance to raltegravir or co-administered nucleoside backbone.

7. No prior history of virologic failure.

Exclusion Criteria:

1. Clinical evidence of decompensated liver disease (e.g., ascites, esophageal varices, or hepatic encephalopathy hepatoma or hepatocellular carcinoma).

2. Chronic Hepatitis B infection (defined as positive HBsAg or Hepatitis B viral load greater than 10,000 copies/mL).

3. AFP greater than or equal to 200 ng/mL at screening.

4. Known or suspected Wilson's disease, alpha-1-antitrypsin deficiency, celiac disease or other cause of chronic liver disease.

5. Chronic renal insufficiency (eGFR < 20 mL/min) at screening.

6. Pregnancy and planned pregnancy (WOCBP not using adequate contraception).

7. Women who are breastfeeding.

8. 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).

9. Patients intending to start HCV therapy within the treatment phase (within the year following the baseline visit).