Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults
A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).
Drug: Pegylated interferon alfa-2a
Drug: Tenofovir disoproxil fumarate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin|
- HCV viral load at least 2 log10 less than baseline or below the limit of detection by quantitative assay at 12 weeks after the start of HCV treatment (early virologic response)
- HIV and/or HCV treatment-limiting or Grade 4 or higher signs and symptoms and laboratory values
|Study Completion Date:||January 2007|
An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One infection often accelerates the progression of the other, and effective management strategies for both infections need to be developed for HCV/HIV coinfected patients. This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone.
This study will last up to 102 weeks. Participants will be randomly assigned to one of two arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.
Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in Arm B will be followed for an additional 48 weeks with no treatment.
There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all visits, and urine collection will occur at selected visits. Participants will also be asked to complete adherence questionnaires. Participants in this study are encouraged to also enroll in ACTG A5128.
|United States, New York|
|Columbia Univ., HIV Prevention and Treatment Medical Ctr.|
|New York, New York, United States, 10032-3784|
|United States, Texas|
|Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic|
|Dallas, Texas, United States, 75235-9173|
|Study Chair:||Barbara Gripshover, MD||University Hospitals of Cleveland, Case Western Reserve University|
|Study Chair:||Mark S. Sulkowski, MD||Viral Hepatitis Center, Johns Hopkins University School of Medicine|