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HCV Infection clinical trials

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NCT ID: NCT04134767 Completed - HIV Infections Clinical Trials

Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails or otherwise involved in the criminal justice system. This study will compare people in a health linkage intervention with people who will get overdose (OD) education. Everyone will take part in the baseline and follow-up surveys and receive OD education. Participants will be assigned to one of the two groups by chance based on when they are enrolled to the study and if their county is randomly assigned to an intervention or a comparison condition. By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C virus (HCV), and overdose education to people leaving rural jails or otherwise involved in the criminal justice system will reduce substance use and related harms.

NCT ID: NCT04062253 Completed - HIV Infections Clinical Trials

Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid

(UMC)
Start date: February 15, 2019
Phase:
Study type: Observational [Patient Registry]

Data on the prevalence of hepatitis C virus (HCV) for other vulnerable groups in Madrid, such as homeless persons and migrants, are scarce, and it is now necessary to implement intervention and elimination plans. Vulnerable groups have poor access to healthcare and are therefore not systematically screened for HCV. On the occasions they are shown to be positive, subsequent follow-up in the health system and the possibility of cure are poor. The use of a mobile unit to approach vulnerable populations is essential for better characterization of risk behaviors and of the magnitude of HCV. The integration of healthcare personnel in mobile units enables counseling on prevention and intervention when needed. Primary objective Evaluate the impact of the HCV care cascade on vulnerable populations who gather at hot spots in Madrid (shantytowns, homeless shelters and places were street prostitution is practiced) by means of a multilevel outreach project. SURVEILLANCE: Active screening for HCV among vulnerable individuals in populations with a high prevalence of HCV will be carried out in hot spots in Madrid, namely, Cañada Real shanty town, mobile harm reduction units, institutions providing social assistance, public areas, homeless shelters and places where street prostitution is practiced. An agreement with the Madrid Council (MCC) is under way to provide social centers for HCV screening. A mobile unit will approach the hot spots following a predefined schedule. The mobile unit consists of a van adapted for the project and a car. HCV screening of vulnerable individuals will be performed by a nurse and an educator hired specifically for that purpose. Active HCV screening and prevention in vulnerable individuals should be a priority and a responsibility shared by both the MCC and the SERMAS (Servicio Madridleño de Salud). The investigators plan to establish an agreement with public health authorities to give continuity to this project and to carry out proactive HCV screening through integration with various centers and networks dependent on the MCC and SERMAS. The project will establish the foundations of integrated cooperation between an HCV clinic in a hospital setting and harm reduction units and other resources and networks dependent on the institutions mentioned above. As has been observed with other interventions, the functional objective of this project is to provide continuity of care from the institutions. Study Duration (in months) 12 months.

NCT ID: NCT04019717 Completed - Hepatitis C Clinical Trials

Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.

NCT ID: NCT04008927 Completed - Drug Use Clinical Trials

A Community-based Intervention Among Active Drug Users in Montpellier

ICONE
Start date: September 18, 2020
Phase: N/A
Study type: Interventional

The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.

NCT ID: NCT03674125 Completed - HCV Infection Clinical Trials

Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection

Start date: September 4, 2018
Phase: Phase 1
Study type: Interventional

Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus. Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear the virus. HCV affects between 1.3 - 2 billion individuals, or 2-3% of the global population. HCV has a seroprevalence of approximately 1% in developed countries such as the US and Korea. Chronic HCV infection leads to hepatic fibrosis and cirrhosis. This Phase I study will evaluate the safety, tolerability and immunogenicity of GLS-6150 administered intradermally (ID) followed by electroporation at 1.0 mg and 2.0 mg/dose assessing 3 and 4-dose regimens.

NCT ID: NCT03588923 Completed - HCV Infection Clinical Trials

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV Infection

Start date: July 7, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection.

NCT ID: NCT03508115 Completed - HCV Infection Clinical Trials

Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents

Start date: July 28, 2016
Phase:
Study type: Observational

Study about the improvement of cognitive, psychopathological and functional abilities in Hepatitis C Virus (HCV) infected patients after eradication of the virus with direct antiviral agents.

NCT ID: NCT03379506 Completed - HCV Infection Clinical Trials

Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)

Start date: January 25, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infected participants who are 3 to <18 years of age. Within each age cohort (Cohort 1: 12 to <18 years of age; Cohort 2: 7 to <12 years of age; and Cohort 3: 3 to <7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric granules instead of a tablet.

NCT ID: NCT02783976 Completed - HCV Infection Clinical Trials

Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Start date: October 28, 2016
Phase:
Study type: Observational

This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.

NCT ID: NCT02707601 Completed - HIV-1 Infection Clinical Trials

Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment

Co-STARs
Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.