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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285050
First Posted: January 27, 2011
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University
January 26, 2011
January 27, 2011
August 15, 2016
November 29, 2016
November 29, 2016
January 2011
April 2015   (Final data collection date for primary outcome measure)
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.
HCV RNA [ Time Frame: 48 hours after interferon administration ]
HCV RNA 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.
Complete list of historical versions of study NCT01285050 on ClinicalTrials.gov Archive Site
Not Provided
  • HIV RNA [ Time Frame: Pre and post administration of HIV meds ]
    HIV quantatative viral load
  • ISG [ Time Frame: Pre and post interferon administration ]
    Interferon stimulated genes as assessed in liver tissue and PBMC.
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • HIV Infection
  • Hepatitis C
  • 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
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)
Interventions:
  • Drug: Antiretroviral therapy (ART)
  • Drug: raltegravir
  • Drug: Emtricitabine and tenofovir disoproxil fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2015
April 2015   (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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01285050
NA00040361
R01DA013806 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
David Thomas, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Not Provided
Johns Hopkins University
October 2016

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