Status:
COMPLETED
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C
Hepatitis C
Eligibility:
All Genders
18+ years
Brief 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 Viru...
Detailed Description
In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.
Eligibility Criteria
Inclusion
- ≥ 18 years of age eligible for treatment according to the Summary of Product Characteristics (SmPC)
- Presence of chronic Hepatitis C (with elevated liver enzymes and without decompensation)
- Presence of HCV-RNA and known genotype of the infecting hepatitis C virus
- HIV infection confirmed by positive Enzyme Linked Immunosorbent Assay (ELISA) and Western blot and Cluster of differentiation (CD) 4 cell count \>200/mL
- Treatment-naïve
- Platelets ≥ 75,000/mm\^3
- Neutrophil counts ≥ 1,500/mm\^3
- Thyroid Stimulating Hormone (TSH) must be within normal limits
- Hemoglobin ≥ 10 g/dL (females); ≥ 11 g/dL (males)
- Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants 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 participants 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
- Contraindications according to the European approval and to the SmPC
- 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 participants 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00736242
Start Date
December 1 2005
End Date
December 1 2011
Last Update
February 19 2015
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