Clinical trial NCT00736242: Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
Official title: Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Hepatitis C
HIV Infections
Keywords: HIV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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 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.

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 Criteria:

* ≥ 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Sustained Virologic Response (SVR)
timeFrame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
Secondary outcomes:
measure: Number of Participants With Rapid Virologic Response (RVR)
timeFrame: At Treatment Week 4
measure: Number of Participants With Early Virologic Response (EVR)
timeFrame: From Treatment Week 1 to Treatment Week 12
measure: Participant Study Status at End of Follow-up (EOF)
timeFrame: From EOT to EOF (up to 72 weeks)
measure: Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
timeFrame: From the Baseline Visit up to EOF (up to 72 weeks)
measure: Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
timeFrame: From the Baseline Visit up to EOF (up to 72 weeks)
measure: Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
timeFrame: From the Baseline Visit up to EOF (up to 72 weeks)
measure: Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
timeFrame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).
Other outcomes:
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