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

Phase 4

Completed

• Conditions: HIV Infection; Hepatitis C
• Interventions: Drug: Antiretroviral therapy (ART); Drug: raltegravir; Drug: Emtricitabine and tenofovir disoproxil fumarate

• Registration Number: NCT01285050
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-08-15
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Results First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pre post ART	Antiretroviral therapy (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)
pre post ART	Emtricitabine and tenofovir disoproxil fumarate	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)
pre post ART	raltegravir	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)

Primary Outcome Measures

Name	Time	Method
HCV RNA	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States