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

April 14, 2006
May 17, 2011
September 2000
Not Provided
Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)
Same as current
Complete list of historical versions of study NCT00315432 on ClinicalTrials.gov Archive Site
Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.
Same as current
Not Provided
Not Provided
 
NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection
)A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • HIV
  • Anemia
Drug: Pegylated Interferon and Ribavirin
Not Provided
Henry DH, Slim J, Lamarca A, Bowers P, Leitz G; HIV/HCV Coinfection Natural History Study Group. Natural history of anemia associated with interferon/ribavirin therapy for patients with HIV/HCV coinfection. AIDS Res Hum Retroviruses. 2007 Jan;23(1):1-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
November 2003
Not Provided

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00315432
CR005134
Not Provided
Not Provided
Ortho Biotech Products, L.P.
Not Provided
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP