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Virus Diseases clinical trials

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NCT ID: NCT03253471 Terminated - Hepatitis C Clinical Trials

A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection

Start date: July 7, 2017
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3). Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)

NCT ID: NCT03250910 Completed - Clinical trials for Human Immunodeficiency Virus

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

Start date: August 1, 2016
Phase: Phase 4
Study type: Interventional

Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.

NCT ID: NCT03225794 Recruiting - Clinical trials for Simian Foamy Virus Infection (Disorder)

Simian Foamy Virus Transmission to Humans

Start date: November 1, 2010
Phase:
Study type: Observational

About three quarters of the viral agents that have emerged recently in humans are considered to originate from other animals. These viruses have often evolved and spread into the human population through various mechanisms after the initial contact that resulted in interspecies transmission. However, knowledge of the initial stages of the emergence of viruses and associated diseases is still limited in many cases. Microbiological monitoring in populations at risk of transmission would provide insights into the initiation and early stages of the emergence process. Nonhuman primates (NHPs) share many genetic, physiological, and microbiological features with humans, and are potential sources of many infectious agents. This has been demonstrated for several simian retroviruses. HIV-1 and 2 are believed to have originated from chimpanzee and mangabey viruses, respectively, found in Central and West Africa. The current distribution of the various molecular subtypes of the HTLV-1 oncogenic retrovirus in Africa is mainly the result of numerous instances of interspecies transmission of STLV-1from NHP species in the distant past. Foamy viruses belong to the Retrovidae family and the Spumavirus genus. They are complex exogenous retroviruses and are very common in many animal species, including primates, cats, cattle, and horses, in which they cause persistent infections. The first aim of the work is to study the epidemiological and molecular aspects of the transmission of foamy viruses from monkeys to humans in populations at risk, such as the inhabitants (especially hunters) in the villages of the dense forests of southern Cameroon. It is an area in which NHPs are still very common, with a great diversity of species. The investigators have already shown that the prevalence of foamy viruses is very high in these monkeys and great apes (gorillas and chimpanzees). Contact between these monkeys and the villagers is very frequent, mainly during hunting. The second aim of the project is to study the clinical and biological features of infected people and investigate intrafamilial transmission from infected index cases.

NCT ID: NCT03212833 Recruiting - Hepatitis C Clinical Trials

Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection

Start date: May 1, 2017
Phase: N/A
Study type: Observational

Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000 deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers, was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009). It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al 2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), ( Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals (DAAs) have shown improved efficacy and tolerability compared with interferon (IFN)-containing regimens, and they have become the standard of care for treatment of HCV genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given concentration of insulin produces a less-than-expected biological effect. The prevalence of type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin resistance and insulin resistance induces interferon resistance, steatosis and fibrosis progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained response rate, and increase the risk for the development of steatosis and fibrosis progression, However, the impact of insulin resistance in other genotypes seems not achieve enough importance to impair sustained response, probably due to the high sensitivity to peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could improve sustained response rate in patients with chronic HCV-1 infection when treated with peginterferon plus ribavirin(Romero-Gómez,2006). Objectives: we aim to determine the prevalence of insulin resistance among the patients with chronic hepatitis C virus( HCV) infection and to explore the association between insulin resistance and therapeutic response by comparing the insulin resistance among responders and non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods: The study is intended to include patients of chronic hepatitis C virus infection receiving oral treatment for one year period. All patients will have clinical evaluation, ultrasonographic examination, and laboratory investigations which include complete blood count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and determination of insulin resistance index.The patients will be selected according the selection criteria determined by the National Committee for Control of Viral Hepatitis (NCCVH).

NCT ID: NCT03206346 Completed - Influenza, Human Clinical Trials

Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 13-17 years old patients.

NCT ID: NCT03204409 Withdrawn - Clinical trials for Zika Virus Infection

ZIKAlliance Natural History Study

ZIKAllianceNH
Start date: April 1, 2018
Phase:
Study type: Observational

Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.

NCT ID: NCT03202992 Completed - HIV Infection Clinical Trials

Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Start date: August 11, 2017
Phase: Phase 1
Study type: Interventional

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

NCT ID: NCT03192371 Withdrawn - Virus Diseases Clinical Trials

A Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children

Start date: February 15, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.

NCT ID: NCT03192072 Completed - Clinical trials for Bacterial Infections

A Rapid Test for Acute Respiratory Illness

Radical
Start date: July 17, 2017
Phase:
Study type: Observational

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard. Secondary objectives include: 1. Evaluate the effect of age on the performance of the HR-ARI test 2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test 3. Evaluate the effect of geography on the performance of the HR-ARI test

NCT ID: NCT03191383 Withdrawn - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women