NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

NCT ID: NCT00315432

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2003-11-30

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.

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

Conditions

Hepatitis C; HIV; Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pegylated Interferon and Ribavirin

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ortho Biotech Products, L.P. Clinical Trial

Role: STUDY_DIRECTOR

Ortho Biotech Products, L.P.

References

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. doi: 10.1089/aid.2006.0082.

Reference Type: DERIVED

PMID: 17263626 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=932&filename=CR005134_CSR.pdf

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

Other Identifiers

CR005134

Identifier Type: -

Identifier Source: org_study_id