NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

HIV Clinical Trial

Official title:

)A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315432
• Other study ID #: CR005134
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2006
• Last updated: May 17, 2011
• Start date: September 2000
• Est. completion date: November 2003

Study information

• Verified date: April 2010
• Source: Ortho Biotech Products, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Anemia
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• HIV Infections

Intervention

Drug:
• Pegylated Interferon and Ribavirin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho Biotech Products, L.P.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)
Secondary	Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

External Links

•   A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy or Ribavirin/PEG-Interferon