A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)
NCT ID: NCT00008463
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2000-11-30
2006-08-31
Brief Summary
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HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.
Detailed Description
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Patients are stratified according to HCV genotype and CD4 count and viral load, then randomized to either Arm A (IFN plus ribavirin) or Arm B (PEG-IFN plus ribavirin). Patients receive up to 48 weeks of treatment. Virologic response is assessed at Week 24 and a decision to continue or discontinue treatment is made. If a virologic response is shown at Week 24, the patient continues treatment for an additional 24 weeks. If no virologic response is observed, then the histologic response is assessed by a liver biopsy. If biopsy shows a histologic response is present, treatment is continued for 24 weeks. If biopsy shows no histologic response, treatment is discontinued. \[AS PER AMENDMENT 07/20/01: Patients with virologic response who discontinue after Week 24 will have liver biopsy at time of discontinuation. Patients with no virologic response continuing study treatment after having a liver biopsy within 2 weeks of Week 24, who also demonstrate histologic response and decide to discontinue after Week 24, are strongly encouraged to have a 2nd liver biopsy at the end of treatment. Patients with no virologic response who discontinue after Week 24 will not have liver biopsy at time of discontinuation.\] Physical examinations are done regularly and blood samples collected for routine laboratory tests, confidential genetic testing, and to measure HCV and HIV-1 plasma viral loads. Women able to become pregnant have regular pregnancy tests. All patients are followed for an additional 24 weeks after treatment discontinuation.
Patients may enroll in 1 or none of the following substudies: A5091s, Hepatic C Viral Kinetics in Subjects Co-infected with Human Immunodeficiency Virus-1 (HIV-1) and Hepatitis C Virus Genotype 1 (HCV-1); \[AS PER AMENDMENT 07/20/01: The following text has been deleted: or A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation\] \[AS PER AMENDMENT 07/20/01: Substudy A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation is now a stand-alone study.\]
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Ribavirin
Interferon alfa-2a
Peginterferon alfa-2a
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have chronic liver disease consistent with chronic hepatitis C.
* Have evidence of hepatitis C within the 48 weeks prior to entry.
* Are 18 to 65 years old.
* Agree to use 2 barrier methods of birth control during the study and for 6 months after stopping the medications.
* Meet 1 of the following sets of guidelines: 1) have a CD4 count of more than 100 cells/mm3 and have a viral load (level of HIV in the blood) of less than 10,000 copies/ml within 35 days prior to study entry, and have taken stable anti-HIV drugs for at least 12 weeks prior to study entry and plan to remain on the same treatment for the first 24 weeks of the study; or 2) have a CD4 count of more than 300 cells/mm3 within 35 days prior to study entry and have not taken any anti-HIV drugs in the 12 weeks prior to entry, and do not plan to start anti-HIV treatment within the first 24 weeks of study entry.
Exclusion Criteria
* Have a positive test for hepatitis B.
* Show evidence of medical conditions associated with long-term liver disease other than HCV.
* Have severe mental illness, especially depression, or have been hospitalized for mental illness within the previous 24 weeks.
* Are allergic to any of the study products.
* Have uncontrolled seizures.
* Have had or currently have any immune diseases.
* Have lung disease such that function is limited.
* Have had evidence of heart disease or certain heart problems within 24 weeks of study entry.
* Have severe retinopathy (eye disease).
* Have had a major organ transplant and still have the graft.
* Have any other severe disease or cancer that would interfere with the study.
* Have had anti-cancer or immune-regulating drugs or radiation treatment within 24 weeks of study entry or expect to need such treatment during the study.
* Have received rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, hydroxyurea, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 6 weeks of study entry.
* Abuse drugs or alcohol. Patients in methadone programs may participate.
* Have a blood disorder such as thalassemia.
* Have received interferon or oral ribavirin therapy.
* Have taken an experimental drug that affects HCV, within 6 weeks of study entry.
* Need to use during the study any of the drugs prohibited by the study.
* Have had an opportunistic (AIDS-related) infection within 4 weeks of study entry.
* Are pregnant or breast-feeding.
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Raymond Chung, MD
Role: STUDY_CHAIR
Harvard/Massachusetts General Hospital
Paul Volberding, MD
Role: STUDY_CHAIR
San Francisco General Hospital
Locations
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Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Mt. Sinai Med. Ctr. A0404 CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
AIDS Care CRS
Rochester, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
Philadelphia, Pennsylvania, United States
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, United States
Countries
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References
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R Chung, J Andersen, P Volberding, G Robbins, T Liu, K Sherman, M Peters, M Koziel, B Alston, D Colquhoun, T Nevin, G Harb, C van der Horst, and AIDS Clinical Trials Group A5071 Study Team: A Randomized, Controlled Trial of PEG-Interferon-alfa-2a plus Ribavirin vs Interferon-alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV-co-infected Persons: Follow-up Results of ACTG A5071. CROI 2004. Abstract 110.
Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, Peters MG, Koziel MJ, Bhan AK, Alston B, Colquhoun D, Nevin T, Harb G, van der Horst C; AIDS Clinical Trials Group A5071 Study Team. Peginterferon Alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med. 2004 Jul 29;351(5):451-9. doi: 10.1056/NEJMoa032653.
Plosker GL, Keating GM. Peginterferon-alpha-2a (40kD) plus ribavirin: a review of its use in hepatitis C Virus And HIV co-infection. Drugs. 2004;64(24):2823-43. doi: 10.2165/00003495-200464240-00009.
Sherman KE, Shire NJ, Rouster SD, Peters MG, James Koziel M, Chung RT, Horn PS. Viral kinetics in hepatitis C or hepatitis C/human immunodeficiency virus-infected patients. Gastroenterology. 2005 Feb;128(2):313-27. doi: 10.1053/j.gastro.2004.11.059.
Graham CS, Wells A, Liu T, Sherman KE, Peters M, Chung RT, Bhan AK, Andersen J, Koziel MJ; ACTG 5071 Study Team. Antigen-specific immune responses and liver histology in HIV and hepatitis C coinfection. AIDS. 2005 May 20;19(8):767-73. doi: 10.1097/01.aids.0000168970.80551.3d.
Jones R, Dunning J, Nelson M. HIV and hepatitis C co-infection. Int J Clin Pract. 2005 Sep;59(9):1082-7. doi: 10.1111/j.1742-1241.2005.00596.x.
Graham CS, Wells A, Liu T, Sherman KE, Peters M, Chung RT, Bhan AK, Andersen J, Koziel MJ; ACTG 5071 Study Team. Relationships between cellular immune responses and treatment outcomes with interferon and ribavirin in HIV/hepatitis C virus co-infection. AIDS. 2006 Feb 14;20(3):345-51. doi: 10.1097/01.aids.0000206500.16783.2e.
Bhattacharya D, Umbleja T, Carrat F, Chung RT, Peters MG, Torriani F, Andersen J, Currier JS. Women experience higher rates of adverse events during hepatitis C virus therapy in HIV infection: a meta-analysis. J Acquir Immune Defic Syndr. 2010 Oct;55(2):170-5. doi: 10.1097/QAI.0b013e3181e36420.
Other Identifiers
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10675
Identifier Type: REGISTRY
Identifier Source: secondary_id
Substudy AACTG A5091s
Identifier Type: -
Identifier Source: secondary_id
ACTG A5071
Identifier Type: -
Identifier Source: secondary_id
AACTG A5071
Identifier Type: -
Identifier Source: secondary_id
A5071
Identifier Type: -
Identifier Source: org_study_id