Advertisement

Topics

Leukapheresis for Research on HCV-Coinfected Patients

2014-08-27 03:54:38 | BioPortfolio

Summary

This study will collect quantities of white blood cells from patients infected with the hepatitis C virus (HCV) for research on the interactions between HCV and the human immunodeficiency virus (HIV) in people infected with both of these agents. Several studies have shown that infection with HIV adversely affects liver disease due to HCV.

Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone may be eligible for this study. Candidates must not have liver failure and must not be undergoing treatment for HCV at the time of enrollment.

Participants will undergo leukapheresis to collect white blood cells. This procedure allows collection of larger numbers of cells than would be possible with simple blood drawing. For the procedure, blood is removed through a needle in the vein of one arm and spun in a machine that separates the blood into its components. The white cells are extracted and the rest of the blood is re-infused through the same needle or through a needle in the other arm. The procedure takes approximately 1-3 hours, depending on the amount of white cells being collected. A maximum of three leukapheresis procedures are done. If additional procedures are required, the patient will sign a new consent form. Procedures will be limited to no more than three times a year, or once every 4 months.

...

Description

HCV infection is known to cause morbidity and mortality especially among those who are coinfected with HIV. The underlying immunopathogenesis of persistence of HCV infection, progression of liver disease and interactions with HIV are not yet clearly understood. A clear understanding of the immune correlates of protection against HCV would definitely be important in development of a vaccine for HCV. HCV infected individuals who are also coinfected with HIV have more rapid progression of liver disease, abnormal diagnostic serologies, higher levels of HCV viremia and markedly lower levels of therapeutic responses to the standard combination therapy with peginterferon and ribavirin. This study will recruit individuals who are coinfected with both HIV and HCV as well as those who are monoinfected with HCV. The study will require that patients be apheresed or undergo blood draw several times after enrollment. Apheresis will be necessary in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating CD8+ T factors associated with suppression of viral replication and normalization of immune function, and characterizing natural killer function relative to HCV disease and identify biomarkers for progression of liver disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. Patients who do not meet apheresis criteria may participate through routine blood draws to contribute to this research. All patients will receive a liver biopsy (every 3 years for co-infected and every 5 years for mono-infected subjects) to assess the progression of liver disease performed at the NIH.

Study Design

N/A

Conditions

Hepatitis C

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:38-0400

Clinical Trials [1306 Associated Clinical Trials listed on BioPortfolio]

Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients

Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the...

Investigation of Hepatitis B and Hepatitis C in Taiwan

The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.

Management of Hepatitis C in HIV-Infected and Uninfected IDUs

The purpose of this study is to determine if hepatitis C has damaged the liver, whether each subject's hepatitis C is treatable with currently available medicines, whether patient educatio...

Activation of Hepatitis B Virus (HBV) in Hepatitis B Surface Antigen (HBsAg) - Negative But Hepatitis B Core Antibody (Anti-HBc) - Positive Patients

Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection i...

A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus.

PubMed Articles [1194 Associated PubMed Articles listed on BioPortfolio]

Prevalence and incidence of hepatitis delta in patients with chronic hepatitis B in Spain.

Hepatitis delta virus (HDV) is a defective agent that only replicates in the presence of the hepatitis B virus. Accordingly, HDV acquisition may occur as superinfection of HBsAg+ carriers or following...

Prevalence of non A to E hepatitis in Mumbai, India.

Acute viral hepatitis is a common problem in India. World wide data shows that 5 to 20 percent of this is caused by non A-E hepatitis. There is no data in India regarding non A-E hepatitis. We carried...

Clinical and laboratory characteristics of hepatitis d in Republic of Sakha (Yakutia).

Inrtroduction: The epidemiological situation for hepatitis D has changed significantly. Reduced population authors infection due to a sharp decline in hospitalizations from Central Asia regions, the C...

Comparison of ARIMA and GM(1,1) models for prediction of hepatitis B in China.

Hepatitis B virus (HBV) infection is a major public health threat in China for China has a hepatitis B prevalence of more than one million people in 2017 year. Disease incidence prediction may help he...

World Hepatitis Day - July 28, 2018.

World Hepatitis Day is commemorated each year on July 28 with the goal of promoting awareness and inspiring action to prevent and treat viral hepatitis. The World Health Organization's (WHO's) theme o...

Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

More From BioPortfolio on "Leukapheresis for Research on HCV-Coinfected Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Gastroenterology
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...


Searches Linking to this Trial