Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:January 2011
End Date:April 2015

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

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).

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.

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
We found this trial at
1
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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