Skip to main content
OpenTrials
Completed

NCT Number: NCT01285050

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antiretroviral therapy (ART)

Drug

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.

raltegravir

Drug

raltegravir is an HIV medication given 400 mg twice daily by mouth

Other names: Isentress

Emtricitabine and tenofovir disoproxil fumarate

Drug

Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth

Other names: Truvada

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2011
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.