Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- HCV RNA
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
pre post 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)
干预措施: Antiretroviral therapy (ART) (Drug)
pre post 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)
干预措施: raltegravir (Drug)
pre post 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)
干预措施: Emtricitabine and tenofovir disoproxil fumarate (Drug)
结局指标
主要结局
HCV RNA
时间窗: 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.
次要结局
未报告次要终点
研究者
David Thomas
Chief, Infectious Diseases
Johns Hopkins University