NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

NCT00315432 | Completed Phase 2

• 1 other identifier: CR005134
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C; HIV; Anemia

Keywords

Natural History, Hepatitis C Infection, HIV Infection, HCV/HIV co-infection Ribavirin, Pegylated Interferon, Interferon

Outcome Measures

Primary Outcomes (1)

• Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)

Secondary Outcomes (1)

• Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

Interventions

Pegylated Interferon and Ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Publications (1)

• 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.

  PMID: 17263626 DERIVED

Related Links

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

MeSH Terms

Conditions

Hepatitis C; Anemia; HIV Infections

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: September 1, 2000
• Study Completion: November 1, 2003
• Last Updated: May 19, 2011

Record last verified: 2010-04