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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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HIV Infection, Hepatitis C

Intervention / Treatment
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* Drug: Antiretroviral therapy (ART)
* Drug: raltegravir
* Drug: Emtricitabine and tenofovir disoproxil fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pre post ART<br>HCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART) | Drug: Antiretroviral therapy (ART)<br>* Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.<br>Drug: raltegravir<br>* raltegravir is an HIV medication given 400 mg twice daily by mouth<br>* Other names: Isentress;Drug: Emtricitabine and tenofovir disoproxil fumarate<br>* Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth<br>* Other names: Truvada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA | HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg. | 48 hours after interferon administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS Virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic, Hepatitis C virus, Hepatitis C antibodies, Hepatitis C antigens