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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:
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

January 26, 2011
August 8, 2013
January 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01285050 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy

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.

Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • HIV Infection
  • Hepatitis C
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2015
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rosie Silva 410-502-7134 rsilva6@jhmi.edu
United States
 
NCT01285050
NA00040361, R01DA013806
No
David Thomas, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Not Provided
Johns Hopkins University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP