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

Primary Purpose

HIV Infection, Hepatitis C

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antiretroviral therapy (ART)
raltegravir
Emtricitabine and tenofovir disoproxil fumarate
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV Infection focused on measuring 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

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

pre post ART

Arm Description

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)

Outcomes

Primary Outcome Measures

HCV RNA
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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2011
Last Updated
October 6, 2016
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01285050
Brief Title
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Official Title
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hepatitis C
Keywords
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre post ART
Arm Type
Other
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Antiretroviral therapy (ART)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
raltegravir
Other Intervention Name(s)
Isentress
Intervention Description
raltegravir is an HIV medication given 400 mg twice daily by mouth
Intervention Type
Drug
Intervention Name(s)
Emtricitabine and tenofovir disoproxil fumarate
Other Intervention Name(s)
Truvada
Intervention Description
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Primary Outcome Measure Information:
Title
HCV RNA
Description
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.
Time Frame
48 hours after interferon administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28586923
Citation
Kandathil AJ, Breitwieser FP, Sachithanandham J, Robinson M, Mehta SH, Timp W, Salzberg SL, Thomas DL, Balagopal A. Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs. Ann Intern Med. 2017 Jul 4;167(1):1-7. doi: 10.7326/M17-0085. Epub 2017 Jun 6.
Results Reference
derived
PubMed Identifier
28358734
Citation
El-Diwany R, Breitwieser FP, Soliman M, Skaist AM, Srikrishna G, Blankson JN, Ray SC, Wheelan SJ, Thomas DL, Balagopal A. Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals. AIDS. 2017 Jun 19;31(10):1405-1414. doi: 10.1097/QAD.0000000000001480.
Results Reference
derived

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

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