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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

David Thomas, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01285050

First received: January 26, 2011

Last updated: October 6, 2016

Last verified: October 2016

History of Changes

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).

Condition	Intervention	Phase
HIV Infection Hepatitis C	Drug: Antiretroviral therapy (ART) Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis C

Drug Information available for: Interferon Raltegravir Truvada Raltegravir potassium

U.S. FDA Resources

Further study details as provided by David Thomas, Johns Hopkins University:

Primary Outcome Measures:

HCV RNA [ Time Frame: 48 hours after interferon administration ]
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.


Enrollment:	20
Study Start Date:	January 2011
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pre post ART 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) 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. Drug: raltegravir raltegravir is an HIV medication given 400 mg twice daily by mouth Other Name: Isentress Drug: Emtricitabine and tenofovir disoproxil fumarate Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth Other Name: Truvada

Arms

Assigned Interventions

pre post ART

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)

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.

Drug: raltegravir

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

Other Name: Isentress

Drug: Emtricitabine and tenofovir disoproxil fumarate

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

Other Name: Truvada

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285050

Locations


United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

More Information


Responsible Party:	David Thomas, Chief, Infectious Diseases, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01285050 History of Changes
Other Study ID Numbers:	NA00040361 R01DA013806 ( US NIH Grant/Contract Award Number )
Study First Received:	January 26, 2011
Results First Received:	August 15, 2016
Last Updated:	October 6, 2016

Keywords provided by David Thomas, Johns Hopkins University:


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

Additional relevant MeSH terms:


Hepatitis Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Interferons Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on May 25, 2017

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