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Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs (BYE-C)

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ClinicalTrials.gov Identifier: NCT02609893
Recruitment Status : Unknown
Verified September 2017 by Phillip Coffin, MD, MIA, San Francisco Department of Public Health.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
Official Title  ICMJE Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Other: modified directly observed therapy (mDOT)
  • Other: unobserved dosing
  • Other: Motivational Interviewing-based counseling
    Motivational Interviewing-based risk reduction and medication adherence counseling
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: modified directly observed therapy (mDOT)
    • Other: Motivational Interviewing-based 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
    Interventions:
    • Other: unobserved dosing
    • Other: Motivational Interviewing-based counseling
Publications * Coffin PO, Santos GM, Behar E, Hern J, Walker J, Matheson T, Kinnard EN, Silvis J, Vittinghoff E, Fox R, Page K. Randomized feasibility trial of directly observed versus unobserved hepatitis C treatment with ledipasvir-sofosbuvir among people who inject drugs. PLoS One. 2019 Jun 3;14(6):e0217471. doi: 10.1371/journal.pone.0217471. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
30
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609893
Other Study ID Numbers  ICMJE 1R34DA039333( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phillip Coffin, MD, MIA, San Francisco Department of Public Health
Study Sponsor  ICMJE Phillip Coffin, MD, MIA
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Phillip O Coffin, M.D. San Francisco Department of Public Health
Study Director: Emily Behar, MS San Francisco Department of Public Health
PRS Account San Francisco Department of Public Health
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP