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

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; HIV Infection

Treatments: Drug: raltegravir; Drug: Emtricitabine and tenofovir disoproxil fumarate; Drug: Antiretroviral therapy (ART)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01285050

R01DA013806 (U.S. NIH Grant/Contract)

NA00040361

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

pre post ART

Other group

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)

Treatment:

Drug: Antiretroviral therapy (ART)

Drug: Emtricitabine and tenofovir disoproxil fumarate

Drug: raltegravir