A5329: HCV GT 1 AbbVie

ACTG A5329: Interferon –Free Therapy for Chronic Hepatitis C Virus Genotype 1 infection in persons with HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy: A5334s Pharmacokinetic Substudy

Study Description
A5329 is a study for people who are infected with both HIV and the Hepatitis C virus (HCV) and have never taken Hepatitis C medications or who had unsuccessful treatment with pegylated or standard IFN alfa with or without RBV. New “direct acting antiviral” drugs (DAAs) ABT-450/r/ABT-267 plus ABT-333 will be tested as part of a drug regimen that does not contain the drug interferon for either 24 or 12 weeks of treatment.

In order to be screened for this study, potential participants also have to be screened to participate in A5335s, the Liver Biopsy substudy for A5329. A5335s has a separate protocol and a separate consent form that must be signed before any evaluations for A5329.

If A5335s screening tests show that a potential participant is not eligible to participate in A5335s, the Liver Biopsy substudy, or he/she chooses not to participate in A5335s, he/she will not be able to continue in this study. He/she will not receive any study medications for this study and will not have any further evaluations for this study.

Why is this study being done?
This study will test if these DAAs can effectively treat HCV and if they are safe and well tolerated in people who have HIV and HCV. These regimens could be useful in treating people who are infected with both HCV and HIV because they often do not respond well to interferon (it does not treat their HCV effectively and they may have complications from taking the drug, such as depression and changes in their blood counts).

Who can join?

  • HIV and Hepatitis C co-infected people 18 to 70 years old
  • Classification of liver disease as non-cirrhotic prior to study entry
  • No prior HCV treatment or unsuccessful treatment with pegylated or standard IFN alfa with or without RBV
  • HCV viral load greater than 10,000
  • HCV genotype 1
  • HIV viral load less than 50 copies
  • On a qualifying ART regimen (see protocol for qualifying regimens)
  • CD4 count greater than 200

What do I need to do in the study?

All participants will receive:  

  • ABT-450/ritonavir/ABT- 267 once a day plus
  • ABT-333 twice a day plus
  • Ribavirin twice a day.  

All medications will be taken by mouth. Participants will be treated for either 12 or 24 weeks and will be followed up to 48 weeks on study.

What treatments or drugs are involved with this study?
Study drugs that will be provided are ABT-450/ritonavir/ABT-267, ABT-333 and weight-based ribavirin. Participants will continue taking their HIV regimen, but the HIV medications will not be provided by the study. 

Study Status: