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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 aimed 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 believed that switching patients from a PI-based regimen to raltegravir would 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 used 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.


The ability of study investigators to detect changes between the two groups was hindered by unexpectedly slow recruitment; only nine were recruited of the proposed 40 participants. No changes in fibrosis or metabolic measurements were seen between the groups; adverse events were mild and HIV control was maintained in the raltegravir group.

Dr. Klein and the study team concluded that raltegravir is a safe option for treatment of HIV-HCV co-infection however its impact on liver fibrosis should be investigated in future studies.

Participating sites

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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