Status:
TERMINATED
Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepacivirus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combinatio...
Eligibility Criteria
Inclusion
- Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.
- Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy.
- Liver transaminases (alanine aminotransferase \[ALT\]) 1.5-fold above the upper limit of normal.
- Controlled HIV infection with a viral load \<10,000 copies/mL and a CD4 cell (T-cell) count \>200 x 10\^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required.
- Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic criteria at the Entry visit.
- Alpha-fetoprotein value within normal limits obtained within one year prior to entry. Results above the upper limit of normal but \<=50 ng/mL require both of the following: Alpha-fetoprotein value \<=50 ng/mL obtained within 3 months prior to entry in the study and Ultrasound obtained within 3 months prior to entry in the study or that is negative for evidence of hepatocellular carcinoma.
- Liver biopsy (optional) within 12 months prior to study entry with a pathology report confirming that the histologic diagnosis is consistent with chronic hepatitis.
- Women of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
- Reconfirmation that sexually active males must be practicing acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
- Subjects must be free of any clinically significant diseases other than hepatitis or HIV infection that would interfere with study evaluations.
Exclusion
- Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.
- HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis.
- Participation in any other clinical trial within 30 days of entry to this protocol.
- Treatment with any investigational drug within 30 days of entry to this protocol.
- Subjects with organ transplants other than cornea and hair transplant.
- Any cause for the liver disease based on subject history and biopsy (where applicable) other than chronic hepatitis C, including but not limited to coinfection with hepatitis B virus (HBV); hemochromatosis (iron deposition \>2+ in liver parenchyma); alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease.
- Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
- Hemoglobinopathies (eg, Thalassemia)
- Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, and encephalopathy.
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.
- Significant cardiovascular dysfunction within the past 6 months (eg, angina, congestive heart failure, recent myocardial infarction, severe hypertension, or significant arrhythmia). Subjects with electrocardiogram (ECG) showing clinically significant abnormalities.
- Poorly controlled diabetes mellitus.
- Chronic pulmonary disease (eg, chronic obstructive pulmonary disease).
- Immunologically mediated disease.
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Clinical gout.
- Clinically significant retinal abnormalities.
- Alcohol consumption of \>20 gr/day.
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00687544
Start Date
December 1 2005
End Date
September 1 2008
Last Update
April 6 2017
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