HIV Clinical Trial - Eliminating Hepatitis C Transmission by Enhancing

Status Completed

Clinical Trial Summary

This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection, thereby reducing new primary infections and re-infection.

Clinical Trial Description

The co-EC study aims to to enhance HCV care and treatment among HIV-infected individuals through a predominantly nurse-led model of care in primary care as well as hospital settings. It involves:

1. A nurse-led model of care in primary health care to increase access to PBS HCV treatment with interferon-free HCV antiviral treatment; and

2. An integrated HCV/HIV surveillance system and database to deliver and monitor the impact of the program at the local and statewide level.

The study is based in Victoria, Australia where the highest prevalence of HIV/HCV co-infection is in gay and bisexual men (GBM). HCV infection is a significant health issue among individuals with HIV infection and has been associated with more rapid progression to HCV-related liver disease and increased risk for cirrhosis and liver cancer. Hepatitis C is a major cause of hospital admissions and is a leading cause of death among HIV-infected persons.

The advent of directly acting antiviral (DAA) treatment provides us with a unique opportunity to increase the number of people accessing hepatitis C treatment. Importantly it is likely that the treatment could be administered in the primary health care setting improving treatment capacity and accessibility, whilst potentially reducing treatment costs.

The primary objectives of co-EC Study are:

1. Achieve HCV sustained virological response (SVR12) to treatment among HIV co-infected participants in a real-world primary care or hospital clinic setting; and

2. Measure the impact of treating HCV in HIV infected individuals on primary HCV and reinfection incidence and HCV prevalence in gay and bisexual men in Victoria.

The study design involves an open label, non-randomised clinical trial of hepatitis C treatment for people with HIV coinfection. Treatment will involve any combination of hepatitis C antiviral therapy approved for use in Australia appropriate for the participants' hepatitis C genotype and selected at the decision of their treating clinicians. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02786758
Study type	Observational
Source	Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Contact
Status	Completed
Phase
Start date	April 2016
Completion date	August 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06162897` - Case Management Dyad	N/A
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT02528773` - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting	`NCT05454839` - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting	`NCT05322629` - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women	N/A
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Active, not recruiting	`NCT01790373` - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence	N/A
Not yet recruiting	`NCT06044792` - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed	`NCT04039217` - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM	Phase 4
Active, not recruiting	`NCT04519970` - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)	N/A
Completed	`NCT04124536` - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women	N/A
Recruiting	`NCT05599581` - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT02758093` - Speed of Processing Training in Adults With HIV	N/A
Completed	`NCT02500446` - Dolutegravir Impact on Residual Replication	Phase 4
Completed	`NCT03805451` - Life Steps for PrEP for Youth	N/A
Active, not recruiting	`NCT03902431` - Translating the ABCS Into HIV Care	N/A
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Recruiting	`NCT05736588` - Elimisha HPV (Human Papillomavirus)	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals — co-EC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms