About The Study

This CTN study will examine the efficacy and feasibility of managing HIV infection in the setting of hepatitis C (HCV) using a combination therapy of lopinavir/ ritonavir (Kaletra®) and maraviroc (Celsentri®). Kaletra is a single tablet protease inhibitor, designed to prevent infected HIV cells from producing more virus. Celsentri is an HIV medication that may have an anti-fibrotic, or anti-scarring, effect on the liver. The study is designed to respond to concerns about the potential toxicity of standard combination antiretroviral therapy (cART) in conjunction with therapies used to treat HCV. Study researchers seek evidence that combination therapy with Kaletra and Celsentri will effectively suppress viral loads and increase the efficacy and decrease the toxicity of subsequent HCV therapy for people living with HIV/HCV co-infections. Pending results from this observational pilot study, the research team plan to move into a larger Phase II trial that will investigate HCV treatment in addition to managing HIV disease progression.

About The Disease

Approximately 30% of HIV+ patients are co-infected with hepatitis C. Increasing numbers of people living with both HIV and HCV require treatment for both infections, yet there are increasing concerns that standard HIV combination therapies for treating HIV can intensify risks of toxicitiy and impact negatively on the treatment of HCV. A large number of co-infected patients are at risk of progressing to severe liver disease that could lead to death. The recent PROGRESS (PROtease/InteGRasE Simplification Study) study suggests that the combination of Kaletra and Isentress is as effective as conventional cART in managing HIV over 48 weeks.

Study Approach

This will be a single arm, observational pilot study conducted at inner city clinics in British Columbia. Trial participants will receive a combination of Kaletra 4 tabs and Celsentri 300 mg daily, and observed for 24 weeks. After initiating study therapy, participants will be followed according to the standard of care for 24 weeks, and observed for any drug-related toxicity, with the primary endpoint being maintenance of antiretroviral efficacy over the period of observation.

  • One tube (10 mL or 2/3 Tbsp) of blood will be drawn and sent for syphilis testing
  • Adverse events will be recorded
  • Participants will be asked the following questions about their recent sexual behaviour in order to differentiate between treatment failure and re-infection
    • Number of partners
    • Nature of the sexual encounters (oral/anal/vaginal)
    • Use of safer sex practices

Eligibility Requirements

Required

  • HIV antibody positive
  • HCV antibody positive with viremia
  • On stable cART with HIV plasma viral load 6 months
  • Medical indication for immediate treatment of HCV infection

Not Allowed

  • Age 70 years old
  • Pregnant or lactating women
  • Absence of medical indication to treat HCV infection
  • Life expectancy < 2 years
  • Contraindication to the use of Kaletra
  • Non-R5 tropism assay result
  • Evidence of reduced susceptibility to Kaletra
  • CT or TT IL-28 genotype
  • Contraindication to the use of Interferon and/or Ribavirin
  • Inability to comply with the requirements of the study

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Participating Sites

Here’s where this study is being conducted.