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

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University Identifier:
First received: January 26, 2011
Last updated: February 22, 2016
Last verified: February 2016
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:

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.

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
Drug: Anti-HIV Agents
Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
Other Name: PegIntron
Drug: raltegravir
HIV medication, 400 mg twice daily by mouth
Other Name: Isentress
Drug: Emtricitabine and tenofovir disoproxil fumarate
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.

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

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
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Please refer to this study by its identifier: NCT01285050

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 Identifier: NCT01285050     History of Changes
Other Study ID Numbers: NA00040361  R01DA013806 
Study First Received: January 26, 2011
Last Updated: February 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
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:
HIV Infections
Hepatitis C
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Raltegravir Potassium
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Anti-HIV Agents
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents processed this record on October 27, 2016