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NCT ID: NCT02714985 Withdrawn - Chikungunya Fever Clinical Trials

RT-PCR on Urine Samples: Added Value for the Diagnosis of Chikungunya Virus Infection

CHIK_urine
Start date: March 1, 2016
Phase:
Study type: Observational [Patient Registry]

Retrospective laboratory evaluation of the detection rate of CHIKV infection by real-time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on urine. Urine and serum samples from patients with confirmed CHIKV infections from an endemic area (Aruba) and from ITM will be analyzed. The results will be evaluated on a case-by-case basis: time since onset, patient characteristics, severity of symptoms, serology results. The positivity in-time of CHIKV RNA in urine will be evaluated in comparison with viremia. Patients with suspected acute CHIKV infection will be asked (by written informed consent; annex 1) to provide urine samples within 72 hours after onset of disease, followed by urine samples on day 7, day 10, day 14 and three urine samples 3, 4 and 12 weeks after onset. They will be asked to provide serum samples within 72 hours after onset of disease, followed by serum samples on day 7, day 10, day 14. In total, twenty patients with an initial positive result of CHIKV RT-PCR on serum will be included for follow-up. The number of urine samples that will be tested is 140.

NCT ID: NCT02313844 Withdrawn - BK Virus Infection Clinical Trials

Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B)

Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who have weak immune systems. It affects the urinary tract, and can cause frequent urination, blood in the urine, and severe pain. Investigators want to see if they can use a kind of white blood cell called T cells to treat BKV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated BKV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target BKV. In this study, investigators want to find out if the banked BKV-specific T cells derived from healthy donors are safe and can help to treat BK virus infection. The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food and Drug Administration (FDA).

NCT ID: NCT02307591 Withdrawn - Ebola Virus Disease Clinical Trials

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)

EASE
Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.

NCT ID: NCT02271347 Withdrawn - Ebola Virus Clinical Trials

An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

CMX
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.

NCT ID: NCT01813266 Withdrawn - Clinical trials for Chronic Hepatitis C Virus Infection

Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing the New Birth Cohort Recommendations From the CDC, Versus Classical Traditional Strategies With Established Risk Factors

TPEGHCVS
Start date: May 2013
Phase:
Study type: Observational [Patient Registry]

Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute HCV typically leads to chronic infection. Chronic HCV infection is usually slowly progressive. Approximately 5 to 20 percent of chronically infected individuals develop cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for liver transplantation in the United States. Screening for chronic HCV infection is crucial because chronic HCV infection is often asymptomatic, effective treatment is available, and untreated disease carries a high risk of morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do not all agree. All guidelines recommend screening patients at increased risk for HCV (ie: typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC) recommended screening all persons born between 1945 and 1965. At least two studies suggest that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is cost-effective. The studies estimated that if patients found to be HCV positive were treated with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening based upon a birth cohort in patients without risk factors may lead to more false positive results. Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by Intermountain Healthcare providers have been screened. Ambulatory care physicians are not effectively screening patients. It is unclear whether screening based on risk factors alone versus screening based upon risk factors and birth cohort most effectively manages the burden of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is possible that the Intermountain Healthcare population differs in risk from the U.S. population,making guideline application less certain. A well-designed prospective cohort study is needed to understand the risks and benefits of different HCV screening strategies on diagnostic yield and clinical outcomes. The investigators hypothesize that screening based on a person's history of risk factors will detect chronic HCV infection in 2.7 % of the population tested; this would be according to national average. The investigators further hypothesize that screening based on birth cohort and risk factors will identify roughly the same percentage in the tested population. The investigators anticipate usable data within three months which should give us data to describe and publish the effectiveness of different screening strategies. The investigators will identify patients with chronic HCV infection through this initial study who now require treatment and management. The investigators believe this group could be followed inexpensively for clinical endpoints for many years. This would then definitively define the effectiveness of screening strategies based on good evidence. No study has evaluated clinical outcomes associated with the different screening strategies for chronic hepatitis c virus infection.

NCT ID: NCT01812135 Withdrawn - Clinical trials for Infection, Viral, Enterovirus

Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

Start date: September 2011
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant

NCT ID: NCT01797419 Withdrawn - Clinical trials for Respiratory Syncytial Virus Infections

Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

NCT ID: NCT01738555 Withdrawn - Clinical trials for Human Immunodeficiency Virus Infection

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.

NCT ID: NCT01062659 Withdrawn - Clinical trials for Hepatitis C, Chronic

Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients

Start date: February 2010
Phase: N/A
Study type: Observational

In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.

NCT ID: NCT00956722 Withdrawn - Clinical trials for Asymptomatic Chronic HCV Carriers

Hyperimmune Bovine Colostrum - TRAVELAN™ for Patients With Chronic Hepatitis C Virus Infection Not Responding to Standard Therapy

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This is an exploratory trial of Bovine Colostrum powder to decrease translocation of gut-derived microbial products and immune activation in HCV infection. The study is designed as a single-arm, open-label, before-and after exploratory trial of 10 weeks of Bovine Colostrum Powder (BCP) to reduce translocation of intestinal microbial products and immune activation in patients suffering from chronic hepatitis C virus (HCV) infection. The study population will include HCV-infected (genotype 1) men and women, ≥ 18 years of age, not receiving anti-viral therapy at the time of enrollment and for at least the previous 3 months. Having failed previous anti-viral therapy (non responders), HCV recurrence after 72 weeks of therapy, developed side effects which mandated stopping anti viral therapy, or not considered eligible for initiation of such treatment, with a plasma HCV RNA level ≥ 1000 I.U.