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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2013 by Johns Hopkins University

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: August 8, 2013

Last verified: August 2013

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: Anti-HIV Agents Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study 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 HIV/AIDS Medicines Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Interferon Alfa-2a Tenofovir Tenofovir Disoproxil Fumarate Raltegravir Truvada Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

HCV RNA [ Time Frame: 48 hours after interferon administration ] [ Designated as safety issue: No ]
HCV RNA 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.

Secondary Outcome Measures:

HIV RNA [ Time Frame: Pre and post administration of HIV meds ] [ Designated as safety issue: No ]
HIV quantatative viral load
ISG [ Time Frame: Pre and post interferon administration ] [ Designated as safety issue: No ]
Interferon stimulated genes as assessed in liver tissue and PBMC.


Estimated Enrollment:	40
Study Start Date:	January 2011
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.

Other Name: PegIntron

HIV medication, 400 mg twice daily by mouth

Other Name: Isentress

HIV medication, 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 and older
Genders Eligible for Study:	Both
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

Contacts


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

Locations


United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rosie Silva 410-502-7134 rsilva6@jhmi.edu
Principal Investigator: David L Thomas, MD, MPH

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

More Information

No publications provided


Responsible Party:	David Thomas, Chief, Infectious Diseases, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01285050 History of Changes
Other Study ID Numbers:	NA00040361, R01DA013806
Study First Received:	January 26, 2011
Last Updated:	August 8, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 C Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Liver Diseases RNA Virus Infections Virus Diseases Interferon-alpha Tenofovir Tenofovir disoproxil Anti-HIV Agents	Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Physiological Effects of Drugs Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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