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Trial record 1 of 1 for:    bye-c
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Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs (BYE-C)

This study is currently recruiting participants.
Verified October 2016 by Phillip Coffin, MD, MIA, San Francisco Department of Public Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02609893
First Posted: November 20, 2015
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
  Purpose
This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.

Condition Intervention Phase
Chronic Hepatitis C Other: modified directly observed therapy (mDOT) Other: unobserved dosing Other: Motivational Interviewing-based counseling Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs

Further study details as provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:

Primary Outcome Measures:
  • Number of people who inject drugs (PWIDs) with HCV who were recruited and retained [ Time Frame: 44 weeks ]
    To determine the feasibility of treating active PWIDs for HCV with LDV-SOF by mDOT versus unobserved dosing based on proportion eligible and enrolled among those screened and completion rates overall and by arm.

  • Medication adherence to study drug [ Time Frame: 44 weeks ]
    To evaluate the acceptability of mDOT versus unobserved dosing, the percent of treatment medication adherence to LDV-SOF, as measured by the percent of doses taken overall (observed and unobserved), will be assessed using DOT doses and weekend Wise Pill data for the mDOT arm, and WisePill data for the unobserved dosing arm.

  • Challenges of medication adherence [ Time Frame: 44 weeks ]
    To assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT versus unobserved dosing for PWIDs treated with LDV-SOF.


Secondary Outcome Measures:
  • SVR (end-of-treatment response) [ Time Frame: 12 weeks ]
    We will compare the proportion of participants with undetectable HCV RNA at week 8 and post-treatment week 12 between arms.

  • SOF/metabolite levels [ Time Frame: 8 weeks ]
    SOF/metabolite-positivity rates will be calculated by week in both arms.

  • HCV relapse and reinfection [ Time Frame: 36 weeks ]
    Among participants who achieve SVR, we will determine the proportion who experience HCV relapse and reinfection at post-treatment week 36, overall and by arm.

  • Social and injector networks of participants [ Time Frame: 44 weeks ]
    We will characterize injector network sizes at baseline and follow-up through ACASI surveys.


Estimated Enrollment: 30
Study Start Date: December 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modified Directly Observed Therapy
Ledipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) observed daily dosing (modified for non-observed Saturday and Sunday dosing) for 8 weeks
Other: modified directly observed therapy (mDOT) Other: Motivational Interviewing-based counseling
Motivational Interviewing-based risk reduction and medication adherence counseling
Active Comparator: Unobserved Dosing
Ledipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) provided weekly (7 tablets) for unobserved daily dosing for 8 weeks
Other: unobserved dosing Other: Motivational Interviewing-based counseling
Motivational Interviewing-based risk reduction and medication adherence counseling

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years of age;
  2. 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;
  3. HCV genotype 1;
  4. HCV RNA <6 million copies by Roche TaqMan Assay
  5. No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25—an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]);
  6. Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),
  7. injected with others in past 12 months by self-report;
  8. Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN);
  9. Able to speak English;
  10. No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly;
  11. for women of childbearing age, pregnancy test negative, not actively nursing, and agree to use birth control during treatment (although LDV-SOF has a "B" rating, consistent with no known evidence of harm, treatment is not urgent for these patients so we will err on the side of caution).

Exclusion Criteria:

  1. HIV+ by rapid test or pooled viral load;
  2. HBV surface antigen +;
  3. Non-definitive HCV genotype results;
  4. Previously received treatment for HCV (interferon, ribavirin, or DAA);
  5. Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]);
  6. History of any of the following:

    1. Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
    2. History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
    3. History of solid organ or bone marrow transplantation.
    4. Current treatment for cancer
  7. Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);
  8. Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and
  9. Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.
  10. No other conditions that preclude study involvement as determined by PI.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609893


Contacts
Contact: Phillip O Coffin, M.D. (415) 437-6282 phillip.coffin@sfdph.org
Contact: Emily Behar, MS (415) 437-6204 emily.behar@sfdph.org

Locations
United States, California
Substance Use Research Unit Recruiting
San Francisco, California, United States, 94102
Contact: Emily Behar, MS    415-437-6204    emily.behar@sfdph.org   
Principal Investigator: Phillip Coffin, MD, MIA         
Sponsors and Collaborators
Phillip Coffin, MD, MIA
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Phillip O Coffin, M.D. San Francisco Department of Public Health
Study Director: Emily Behar, MS San Francisco Department of Public Health
  More Information

Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT02609893     History of Changes
Other Study ID Numbers: 1R34DA039333 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2015
First Posted: November 20, 2015
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
HCV

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases


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