N/A
N=144
CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Hepatitis C Virus Infection, Response to Therapy of · Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02402218 ↗Enrolled (actual)
144
Serious AEs
19.1%
Results posted
Sep 2019
Primary outcome: Primary: Participants Who Initiated HCV Therapy by Intervention Group — 24; 45; 41 Participants — p=.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual care plus peer-mentors (Other); Usual care plus incentives (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Initiated HCV Therapy by Intervention Group |
24; 45; 41 | .11 |
| SECONDARY Sustained Virologic Response (SVR) Following Treatment by Intervention Group |
22; 41; 37 | .22 |
| SECONDARY Number of Participants With Adverse Events During HCV Treatment by Intervention Group |
13; 24; 20 | — |
| SECONDARY Change in Alcohol Use by Blood Test During HCV Treatment |
20; 38; 32; 0; 0; 2 | 0.33 |
| SECONDARY Change in Illicit Drug Use During HCV Treatment |
16; 37; 34; 5; 4; 2 | 0.30 |
| SECONDARY Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group |
0; 0; 1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02402218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.