CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Completed · Not applicable
Conditions studied: Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
In brief
This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups: 1. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team. 2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection. 3. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study. HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.
Key facts
- Study ID
- NCT02402218
- Run by
- Johns Hopkins University
- People needed
- 144
- Starts
- 2015-08-01
- Expected to finish
- 2017-06-21
- Last updated by the study team
- 2020-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years old or greater
- Hepatitis C genotype 1 infection for at least 6 months
- No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of ascites, bleeding varices, and/or encephalopathy)
- Cluster of Differentiation 4 (CD4) cell count > 100 cells/mm3 for more than 3 months
- HIV RNA positive for more than 3 months
- Ability to communicate effectively with key study personnel
- Willing to give written informed consent and comply with the study requirements
- Life expectancy > 2 year
You may not qualify if…
- Currently receiving Hepatitis C treatment
- Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: <30 mL/min/1.73 m2
- Antiretroviral therapy inclusive of STRIBILD or APTIVUS
- Inability or unwillingness to avoid pregnancy for woman of child-bearing potential and/or to father children during treatment and for a period of 3 months following completion
Where it is running
- Johns Hopkins Hospital : The John G. Bartlett Specialty Practice — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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