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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285050
• Other study ID #: NA00040361
• Secondary ID: R01DA013806
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2011
• Last updated: February 22, 2016
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infection

Intervention

Drug:
• Anti-HIV Agents
Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
• raltegravir
HIV medication, 400 mg twice daily by mouth
• Emtricitabine and tenofovir disoproxil fumarate
HIV medication, combination pill, once per day by mouth

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA	HCV RNA 48 hours after a single dose of peginterferon alfa 2b 1.5 µg/kg.	48 hours after interferon administration	No
Secondary	HIV RNA	HIV quantatative viral load	Pre and post administration of HIV meds	No
Secondary	ISG	Interferon stimulated genes as assessed in liver tissue and PBMC.	Pre and post interferon administration	No