NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Interferons; Ribavirin

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)