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

Johns Hopkins University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

HIV Infection Hepatitis C

Interventions

Antiretroviral therapy (ART)DRUG

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.

raltegravirDRUG

raltegravir is an HIV medication given 400 mg twice daily by mouth

Emtricitabine and tenofovir disoproxil fumarateDRUG

Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours after interferon administration

Data from ClinicalTrials.gov

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