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Coinfection clinical trials

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NCT ID: NCT03252483 Completed - Hiv Clinical Trials

Integrating HIV and Hepatitis C Screening in an Urban Emergency Department

Start date: December 2012
Phase: N/A
Study type: Interventional

This randomized controlled trial was implemented to evaluate the effect of integrating rapid Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults in a New York City Emergency Department participated in the study. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public Health Advocates approached eligible patients in the Emergency Department, performed HIV and HCV raid testing, and delivered test results to participants with post-test counseling. The primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether the addition of an HCV test adversely impacted participants' consent to test for HIV. Questionnaires were also distributed to participants to assess HCV knowledge.

NCT ID: NCT03238040 Completed - Critical Illness Clinical Trials

Biomarkers of Acute Serious Illness in Children

BASIC
Start date: April 1, 2014
Phase:
Study type: Observational

This study is a large multi-centre collaboration between a busy regional paediatric intensive care transport service (Children's Acute Transport Service, CATS), four large paediatric intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of Paediatrics at Imperial College, London. CATS transports over 800 sick children on life support to the three PICUs each year. We aim to improve our understanding of the genetic basis and biological pathways by which children with acute infection or injury become critically ill and develop failure of vital organs, and how these factors influence outcome. We will establish well-characterised cohorts of sick children with diverse pathologies, in whom blood, urine and other samples will be collected at an early stage of critical illness. Samples will be analysed using genomic, transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis and robust risk stratification. We will focus on biomarkers to help distinguish between serious bacterial infections, viral infections and other causes of critical illness; diagnose incipient organ failure; and accurately identify, early on, children at high risk of developing a poor outcome. We will recruit critically ill children at first contact with the CATS team, during emergency transport to PICU. Due to the emergency nature of the research, and minimal risk associated with the study procedure, we will seek deferred, written informed consent from parents/guardians once their child has been stabilised, within 24-48 hours following PICU admission. By studying these important questions, we aim to better understand how we can diagnose and provide early life-saving treatments to critically ill children. The research team have an established track record of successful completion of several large clinical studies in critical care as well as validation of biomarkers in other diseases.

NCT ID: NCT03235349 Completed - Clinical trials for Hepatitis C Virus (HCV)

Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection

VOYAGE-2
Start date: September 29, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.

NCT ID: NCT03222583 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

VOYAGE-1
Start date: October 4, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.

NCT ID: NCT03214679 Completed - Hepatitis C Clinical Trials

Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)

Start date: July 20, 2017
Phase: N/A
Study type: Interventional

The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.

NCT ID: NCT03145753 Completed - HIV Infection Clinical Trials

Education vs Education Plus Intervention in HIV/HCV Diagnosis (DRIVE 03)

DRIVE
Start date: November 18, 2016
Phase: N/A
Study type: Interventional

Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and indicator conditions (RE&IC) questionnaire resulted in same rate of new HIV infection diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP) or EDSUP plus a resourced external program (DRIVE 03). Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs. EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4 PCC´s, not previously included in the study will be offered to participate. HIV testing program will be evaluated by measuring absolute number of new diagnosed infections (NDI) HIV/HCV and costs. Other outcomes considered will be people assigned and offered to participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in care, HIV/HCV treatment and control/eradication will be also monitored.

NCT ID: NCT03126370 Completed - Hepatitis C Clinical Trials

Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)

Start date: January 8, 2018
Phase: Phase 4
Study type: Interventional

This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]), and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to participate. The study will consist of five visits: a screening visit, three abbreviated 4-hour pharmacokinetic visits, and one end-of-study follow-up visit. Subjects will also be asked to use a Wisepill device, which will track medication adherence throughout the study.

NCT ID: NCT03115736 Completed - Clinical trials for HIV and Hepatitis B Coinfection

TAF for HIV-HBV With Renal Dysfunction

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection. The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.

NCT ID: NCT03098121 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

Start date: October 20, 2017
Phase: Phase 4
Study type: Interventional

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

NCT ID: NCT03050905 Completed - HCV Coinfection Clinical Trials

Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B

Start date: June 22, 2017
Phase: Phase 4
Study type: Interventional

HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution. Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment. The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002. A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated. AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population. 3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b. Study Design: .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.