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Co-infections and Concurrent Diseases (CCD)

CTN 260: Raltegravir switch study

A randomized prospective open-label study of switching to raltegravir based antiretroviral therapy (ART) compared to maintaining ritonavir boosted protease inhibitor-based ART on liver fibrosis progression in HIV-HCV co-infected individuals.

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About the study

This pilot study will aim to assess if switching from ritonavir boosted-protease inhibitor (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) after 48 weeks of treatment.

About the disease/condition

Approximately 30% of HIV+ patients are co-infected with Hepatitis C. A large number of co-infected patients are at risk of progressing to severe liver disease that could lead to death. Not all patients respond to HCV treatment or can tolerate it. Therefore other strategies aimed at reducing fibrosis progression are urgently needed.

Patients on HIV treatment (ART) generally experience improved liver outcomes overall, however ritonavir boosted PIs have been associated with increased levels of hepatic enzymes, and in some studies progression of hepatic fibrosis and even hepatic decompensation. Over the longterm, PIs may cause metabolic problems (e.g. fatty liver) that may further add to liver damage.

About the approach/intervention

Study researchers believe that switching patients from a PI-based regimen to raltegravir will reduce the rate of liver fibrosis progression. Raltegravir has a favorable liver safety and metabolic profile (e.g., cholesterol) although it has not been widely studied in the setting of co-infection.

To measure liver fibrosis in participants, researchers will use two non-invasive methods, APRI (Aspartate aminotransferase to platelet ratio index), and FibroScan® — an ultrasound to assess liver stiffness— the stiffer the liver, the greater the degree of fibrosis.

Eligible individuals will be expected to participate in this study for a total of 72 weeks.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:


  • 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.
  • Evidence of fibrosis: APRI score of 1.5 AND/OR liver biopsy score of F2 (within 2 years) AND/OR FibroScan® > 6.9KPa (within 2 years) or clinical evidence of fibrosis as per physicians judgment
  • HIV viral suppression ( No prior evidence of resistance to raltegravir or co-administered nucleoside backbone.
  • No prior history of virologic failure.

Not Allowed

  • Clinical evidence of decompensated liver disease (e.g., ascites, bleeding esophageal varices, hepatic encephalopathy, or hepatoma/ hepatocellular carcinoma).
  • Chronic Hepatitis B infection (defined as positive HBsAg or Hepatitis B DNA 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 (women of child-bearing potential 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).

Participating sites

Participants will be recruited into the study across each province from various clinics, AIDS Service Organizations, social services such as shelters, and through online, peer outreach and other informal networks. If interested in participating or would like more information, please contact a Coordinator in your region.

British Columbia 
Dr. Mark Hull
BC Center for Excellence in HIV/AIDS
St. Paul’s Hospital
B516-1081 Burrard Street
Vancouver, British Columbia V6Z 1Y6
(604) 806-8640

Dr. Brian Conway
Downtown Infectious Diseases Clinic
201-1200 Burrard Street
Vancouver, British Columbia V6Z 2C7
(604) 642 6429

Dr. Curtis Cooper
Ottawa General Hospital
501 Smyth Rd
Ottawa, Ontario K1H 8L6

Dr. Sharon Walmsley
Toronto General Hospital
585 University Avenue
Toronto, Ontario M5G 2N2
(416) 340-3871

Dr. Marina Klein
Montreal Chest Institute (MUHC)
3650 St. Urbain Street
Montreal, Quebec H2X 2P4
(514) 843-2090

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigators

Dr. Marina Klein
Montreal Chest Institute (MUHC)
3650 Saint-Urbain Street, Montreal, Quebec H2X 2P4
Tel: 514 843-2090

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