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
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.
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?
What do I need to do in the study?
All participants will receive:
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.