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

This study is currently recruiting participants.
Verified February 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: February 13, 2013
Last verified: February 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:

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: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  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
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: February 13, 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:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Tenofovir
Tenofovir disoproxil
Emtricitabine
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013