ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01285050
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Hepatitis C Drug: Antiretroviral therapy (ART) Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate Phase 4

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.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
Study Start Date : January 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)
 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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285050


Locations
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Thomas, Chief, Infectious Diseases, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01285050     History of Changes
Other Study ID Numbers: NA00040361
R01DA013806 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2011    Key Record Dates
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by David Thomas, 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
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Interferons
Tenofovir
Interferon-alpha
Raltegravir Potassium
Emtricitabine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Immunologic Factors