NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

This study has been completed.
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00315432
First received: April 14, 2006
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Hepatitis C
HIV
Anemia
Drug: Pegylated Interferon and Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ortho Biotech Products, L.P.:

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

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

Enrollment: 91
Study Start Date: September 2000
Study Completion Date: November 2003
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Ortho Biotech Products, L.P.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00315432     History of Changes
Other Study ID Numbers: CR005134
Study First Received: April 14, 2006
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Anemia
Hepatitis
Hepatitis A
Hepatitis C
Coinfection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hematologic Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Infection
Parasitic Diseases
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014