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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00736242

Purpose

The objective of the study is to assess the safety and efficacy of PegIntron Pen and Rebetol administered to patients coinfected with HIV and HCV. Patients will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatitis C virus and the rates of serious adverse events reported with PegIntron (1.5 ug/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.

Condition	Intervention
Chronic Hepatitis C Hepatitis C HIV Infections	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen Drug: Rebetol (ribavirin; SCH 18908)

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)

Resource links provided by NLM:

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Sustained virologic response [ Time Frame: At the end of treatment (EOT) and 24 weeks post-treatment. Treatment duration is based on EMEA approved labeling. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of serious adverse events [ Time Frame: During treatment and 24-week post-treatment follow-up. Treatment duration is based on EMEA approved labeling. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	December 2005
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1 All patients	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen PegIntron administered at a dose 1.5 ug/kg/week, according to the EMEA approved labeling Drug: Rebetol (ribavirin; SCH 18908) Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA approved labeling

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.

Criteria

Inclusion Criteria:

Patients with chronic hepatitis C according to the European approval and to SPC (serum HCV-RNA-pos.), who are co-infected with HIV
>= 18 years of age
Treatment-naïve
Platelets >= 75,000/mm^3
Neutrophil counts >= 1,500/mm^3
TSH must be within normal limits
Hemoglobin >= 10 g/dL (females); >= 11 g/dL (males)
CD4 >= 200 /ml
Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.

Exclusion Criteria:

Contraindications according to the European approval and to the SPC
Pretreatment of chronic hepatitis C
Liver decompensation
Hypersensitivity to the active substance or to any interferons or to any of the excipients
Pregnant woman
Women who are breast feeding
Existence of or history of psychiatric condition, particular depression, suicidal ideation or suicide attempt
A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
Severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance < 50 ml/min.
Autoimmune hepatitis or history of autoimmune disease
Severe hepatic dysfunction or decompensated cirrhosis of the liver
Pre-existing thyroid disease unless it can be controlled with conventional therapy
Epilepsy and/or compromised central nervous system function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736242

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Germany
Coordinating Location	Recruiting
Munich, Germany

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04584
Study First Received:	July 30, 2008
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00736242 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Schering-Plough:

HIV

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Liver Diseases
Slow Virus Diseases
Hepatitis, Chronic
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Ribavirin
Hepatitis, Viral, Human
Infection
Therapeutic Uses
Hepatitis C
Retroviridae Infections

RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Peginterferon alfa-2b
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on February 08, 2010