NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

Sponsor

Ortho Biotech Products, L.P. (Industry)

Overall Status

Completed

CT.gov ID

NCT00315432

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

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

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 :

Sep 1, 2000

Actual Study Completion Date :

Nov 1, 2003

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)