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.  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. 

  • An optional substudy (A5334s) will study the levels of HIV medications (darunavir and raltegravir) in the blood while taking the Hepatitis C study drugs. 

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). 

  • The purpose of the substudy is to see if there are any changes in how the body absorbs and uses HIV drugs before and after the HCV drugs are taken.  

Who can join?

  • HIV and Hepatitis C co-infected people 18 to 70 years old
  • HIV viral load less than 50 copies
  • Currently on one of the following HIV regimens:  
    • raltegravir or darunavir/ritonavir  AND tenofovir plus FTC or 3TC 
  • No history of resistance or failure of anti-HIV therapy
  • CD4 count greater than 200
  • No prior HCV treatment
  • HCV viral load greater than 10,000
  • HCV genotype 1
  • A5334s Substudy:
    • Enrolled into A5329
    • Ability to remain at the clinical site for two 12-14 hour days
    • No plans to change current HIV medications

What do I need to do in the study?

All participants will receive:  

  • ABT-450/ritonavir/ABT- 267 combination pill 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.

A5334s Substudy:  Blood will be drawn over 12 - 14 hours at Entry and Week 4 at the clinical research unit.

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: