Human Immunodeficiency Virus Clinical Trial
— CHAMPSOfficial title:
CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Verified date | April 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | June 21, 2017 |
Est. primary completion date | January 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital : The John G. Bartlett Specialty Practice | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants Who Initiated HCV Therapy by Intervention Group | The percentage of participants who initiated HCV therapy [Ledipasvir/Sofosbuvir (LDV/SOF)] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC). | at week 1 | |
Secondary | Sustained Virologic Response (SVR) Following Treatment by Intervention Group | The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen | at post-treatment week 12 | |
Secondary | Number of Participants With Adverse Events During HCV Treatment by Intervention Group | Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group | at post-treatment week 12 | |
Secondary | Change in Alcohol Use by Blood Test During HCV Treatment | Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6 | Pre-treatment and at treatment week 6 | |
Secondary | Change in Illicit Drug Use During HCV Treatment | Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6 | Pre-treatment and at treatment week 6 | |
Secondary | Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus. | at post-treatment week 12 |
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