Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults

NCT00100581 | Completed

• 3 other identifiers: A518410133ACTG A5184
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

HIV Infections; Hepatitis C

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Efavirenz DRUG

Lamivudine DRUG

Lopinavir/ritonavir DRUG

Pegylated interferon alfa-2a DRUG

Ribavirin DRUG

Tenofovir disoproxil fumarate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• HIV viral load of greater than 1000 copies/ml within 45 days of study entry
• HCV genotype 1 infected
• CD4 count of 300 cells/mm3 or greater within 45 days prior to study entry
• ART-naive or off ART for at least 6 months
• Willing to accept randomly assigned study treatment
• Willing to use acceptable forms of contraception during the study and for 6 months after stopping all study medications
• Chronic liver disease consistent with chronic viral hepatitis as indicated by either liver biopsy within 2 years prior to study entry or a physician's report of hepatitis C infection for more than 6 months. Participants with cirrhosis or without a liver biopsy result within 2 years of study entry must have a serum alpha-fetoprotein of 100 ng/ml or less and a Child-Pugh score of 6 or higher within 45 days prior to study entry to be eligible for this study.

You may not qualify if:

• Hepatitis B surface antigen positive within 45 days prior to study entry
• HCV genotype other than genotype 1 at any time prior to study entry
• Any medical conditions associated with chronic liver disease other than HCV (e.g., genetic hemochromatosis, autoimmune hepatitis)
• Prior use of intravenous or subcutaneous interferon for more than 2 weeks total at any time prior to study entry
• Known allergy/sensitivity to pegylated interferon alpha-2a, ribavirin, or their formulations
• Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study. Participants in methadone programs are not excluded, but may require methadone dose changes during the study.
• Need to start ART at the time of study entry
• Uncontrolled diabetes mellitus within 30 days prior to study entry
• Previous suicide attempt or hospitalization for a psychiatric illness within 6 months prior to study entry. Participants with psychiatric disease, especially depression, uncontrolled with medication are not eligible for the study.
• Prior or current evidence of immunologically mediated disease (e.g., inflammatory bowel disease, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
• Chronic pulmonary disease associated with functional limitation
• Severe cardiac disease within 24 weeks prior to study entry
• History of severe retinopathy due to diabetes, hypertension, cytomegalovirus, or macular degeneration
• History of major organ transplantation
• Severe illness, cancer, or other conditions that would interfere with the study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Columbia Univ., HIV Prevention and Treatment Medical Ctr.

New York, New York, 10032-3784, United States

Location

Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

Dallas, Texas, 75235-9173, United States

Location

Related Publications (5)

• Mehta SH, Thomas DL, Torbenson M, Brinkley S, Mirel L, Chaisson RE, Moore RD, Sulkowski MS. The effect of antiretroviral therapy on liver disease among adults with HIV and hepatitis C coinfection. Hepatology. 2005 Jan;41(1):123-31. doi: 10.1002/hep.20541.

  PMID: 15619237 BACKGROUND

• 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.

  PMID: 15563253 BACKGROUND

• Sterling RK, Sulkowski MS. Hepatitis C virus in the setting of HIV or hepatitis B virus coinfection. Semin Liver Dis. 2004;24 Suppl 2:61-8. doi: 10.1055/s-2004-832930.

  PMID: 15346248 BACKGROUND

• Sulkowski MS, Moore RD, Mehta SH, Chaisson RE, Thomas DL. Hepatitis C and progression of HIV disease. JAMA. 2002 Jul 10;288(2):199-206. doi: 10.1001/jama.288.2.199.

  PMID: 12095384 BACKGROUND

• Sulkowski MS, Thomas DL. Hepatitis C in the HIV-infected patient. Clin Liver Dis. 2003 Feb;7(1):179-94. doi: 10.1016/s1089-3261(02)00074-0.

  PMID: 12691466 BACKGROUND

Related Links

• Click here for more information on ACTG A5128

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

efavirenz; Lamivudine; Lopinavir; peginterferon alfa-2a; Ribavirin; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyrimidinones; Ribonucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2005
• First Posted: January 4, 2005
• Study Completion: January 1, 2007
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (2)