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Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

NCT00736242 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2015-02-19

Study results available
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Summary

The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.

Conditions

  • Chronic Hepatitis C
  • Hepatitis C
  • HIV Infections

Interventions

BIOLOGICAL

PEG-IFN alfa-2b

Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling

DRUG

RBV

Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736242 on ClinicalTrials.gov