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NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

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ClinicalTrials.gov Identifier: NCT00315432
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects.

Condition or disease Intervention/treatment Phase
Hepatitis C HIV Anemia Drug: Pegylated Interferon and Ribavirin Phase 2

Detailed Description:
Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL, and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia. The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients receiving combination therapy with IFN / RBV. N/A

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: )A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy
Study Start Date : September 2000
Study Completion Date : November 2003

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)

Secondary Outcome Measures :
  1. Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV- infected patients confirmed by HIV-RNA level
  • HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA (b-DNA)
  • Scheduled to commence combination IFN/RBV therapy on Day 1
  • Normal serum creatinine
  • On stable antiretroviral regimen (for HIV) for at least 4 weeks
  • Life expectancy > 6 months

Exclusion Criteria:

  • Patients with history of any primary hematologic disease
  • Anemia attributable to factors such as iron or folate deficiency, pre-treatment
  • hemolysis or gastrointestinal bleeding
  • Has suspected or confirmed significant hepatic disease from an etiology other than
  • HCV (e.g. alcohol, HBV DNA, autoimmune disease etc)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315432


Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00315432     History of Changes
Other Study ID Numbers: CR005134
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: April 2010

Keywords provided by Ortho Biotech Products, L.P.:
Natural History, Hepatitis C Infection, HIV Infection, HCV/HIV co-infection Ribavirin, Pegylated Interferon, Interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action