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View Clinical Trial (Medical Research Study)

Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy

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City:   Baltimore
State:   Maryland
Zip Code:   21287
Conditions:   HIV Infection - Hepatitis C
Purpose:   The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).
Study Summary:   We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.
Criteria:   Inclusion Criteria: - Adult Human - Able to provide written informed consent - HIV antibody positive - HIV viral load positive - HIV treatment naive - Hepatitis C antibody positive - Hepatitis C viral load positive - Hepatitis C treatment naive - Approved to take HIV medications for minimum 9 months - Willing to use contraception, Life expectancy greater than 2 years Exclusion Criteria: - Significant opportunistic infections within 12 month - Hepatitis B positive - Evidence of liver cirrhosis - Decompensated liver disease - Chronic alcohol abuse - Allergy to raltegravir, tenofovir, and/or emtricitabine - Active or suspected malignancy - Sarcoidosis - Active TB - Coronary artery disease - Uncontrolled seizures - Untreated thyroid disease - Untreated diabetes - Weight greater than 125 kg - Severe depression or severe psychiatric disorder - Ongoing alcohol or illicit drug use - Pregnant, nursing, pr planning to become pregnant - Allergy to interferon
NCT ID:   NCT01285050
Primary Contact:   Rosie Silva
Phone: 410-502-7134
Email: rsilva6@jhmi.edu
Backup Contact:   N/A
Location Contact:   Baltimore, Maryland 21287
United States

Rosie Silva
Phone: 410-502-7134
Email: rsilva6@jhmi.edu

Site Status: Recruiting
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  • Clinical trials for Hepatitis C in Baltimore, Maryland
Data Source:   ClinicalTrials.gov
Date Processed:   May 23, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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