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Clinical Trials

MainTitle

Sofosbuvir and Ledipasvir in HIV/HCV Coinfected Pre or Post Liver Transplant (STOP-CO)

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2016 by Peter Stock, University of California, San Francisco

Sponsor
University of California, San Francisco

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Icahn School of Medicine at Mount Sinai
Columbia University
University of Pennsylvania
University of Maryland
Georgetown University
Johns Hopkins University
National Institutes of Health Clinical Center (CC)

Information provided by (Responsible Party)
Peter Stock, University of California, San Francisco

ClinicalTrials.gov Identifier
NCT02533934

First received: August 25, 2015
Last updated: December 2, 2016
Last Verified: December 2016
History of Changes
Purpose

Purpose

Pilot, open-label study using fixed dose combination of sofosbuvir /ledipasvir to treat HIV/HCV coinfected pre or post liver transplant participants

Condition Intervention Phase
HIV
Hepatitis C
Cirrhosis

Drug : Harvoni
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir and Ledipasvir for Hepatitis C Treatment in HIV/HCV Coinfected Subjects Pre or Post Liver Transplant

Further study details as provided by Peter Stock, University of California, San Francisco:

Primary Outcome Measures

  • Proportion of subjects achieving SVR12 (HCV RNA [ Time Frame: 12 weeks post treatment ]
Secondary Outcome Measures:
  • Correlation of the slope of HCV viral load decline (early viral kinetics) with sustained virologic response at 24 weeks post-treatment (SVR24) [ Time Frame: 24 weeks post treatment ]
  • Proportion of subjects achieving SVR4 and SVR24 (HCV RNA < LLOQ at 4 and 24 weeks after completion of treatment) [ Time Frame: 4 and 24 weeks post treatment ]

Estimated Enrollment: 50
Study Start Date: August 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Study Drug
Treatment with Harvoni
Drug: Harvoni

Treatment of Hepatitis C with Harvoni

Other Name: SOF/LDV

Detailed Description:

Fifty HIV/HCV coinfected liver transplant candidates and recipients with HCV infection will be enrolled into this study. Approximately 25 pre-transplant and 25 post-transplant patients will be included.
The cohort of wait-listed patients with cirrhosis due to hepatitis C will be treated with SOF/LDV until LT or for a maximum of 24 weeks. Patients with and without HCC within Milan criteria are eligible.
Another cohort of liver transplant recipients with recurrent HCV infection post liver transplant will also be treated with SOF/LDV for a period of 12 weeks (no cirrhosis) or 24 weeks (cirrhosis). Patients with fibrosing cholestatic hepatitis are eligible and will be treated for 12 weeks.
Starting with Day 0, all subjects will receive SOF/LDV for 12 or up to 24 weeks. The total amount of time required to complete all the study visits is approximately 56 - 68 weeks from the screening period through the end of the follow-up visits:

  • Up to 8 weeks Screening period
  • 12 or 24 week treatment period
  • 12 and 24 week post-treatment follow-up visits (SVR12 and SVR24)
ks post-treatment to assess late viral relapse

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

1. Over 18 years of age at screening

  1. A female is allowed to enter and participate in the study if she is either of:
      1. Non-childbearing potential
      2. Childbearing potential, has a negative urine pregnancy test at day 0 prior to dosing, and agrees to acceptable birth control
    1. Has received a liver transplant for HCV or is wait-listed for liver transplantation due to complications of HCV-cirrhosis (must be approved for transplant and listed internally or with UNOS)
    2. Have HIV-1 infection and either:
        1. On protocol approved HIV medications (antiretrovirals) for at least 4 weeks WITH an HIV viral load less than the level of detection OR
        2. On no HIV medications for at least 8 weeks WITH a CD4 count of 500 cells/mm3 or more OR an HIV viral load of < 500 copies/mL with a stable CD4 count for at least 3 months
      1. Chronic HCV infection as documented by at least one measurement of plasma HCV RNA ≥ 1,000 IU/mL during screening and at least one of the following:

      A positive anti-HCV antibody, HCV RNA, or an HCV genotype test at least 12 months prior to baseline (Day 0) visit together with positive HCV RNA test
    3. HCV genotype 1, 3, 4, or 6
    4. Able to effectively communicate with the Investigator and other center personnel.
    5. Willing to give written informed consent and comply with the study restrictions and requirements.
    6. NIH ONLY: Have a primary transplant hepatologist outside of the NIH for medical management.
    7. Willingness to allow stored blood or tissue samples to be used in the future for studying liver disease and immune function.
    8. Willingness to permit HLA typing to be performed.
    9. Have a transplant team responsible for all primary and transplant-related care.


Exclusion Criteria:
    1. Historically documented positive test at Screening for HBsAg, anti-HBc IgM Ab, and/or positive HBV DNA.
    2. History of any other clinically active chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, ≥1-antitrypsin deficiency, alcoholic liver disease, and toxin exposures).
    3. Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis treatment, such as Milk thistle, St. Johns Wort or Cats Claw, within 28 days of start of treatment
    4. Treatment with IFN, RBV, telaprevir or boceprevir or any other approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
    5. Any prior exposure to an HCV NS5a specific inhibitor
    6. A personal history of or first degree relative with a history of Torsade de pointes.
    7. Abnormal hematological and biochemical parameters, including:Hemoglobin < 8g/dL; Estimated GFR, calculated by the CKD-EPI equation, <30 mL/min/ per 1.73 m2; Sodium <120 mmol/L
    8. History of major organ transplantation other than liver or kidney transplantation.
    9. Difficulty with blood collection/poor venous access for phlebotomy that would prevent the collection of study required samples
    10. Infection requiring systemic antibiotics at the time of screening
    11. Active or recent history (≤ 6 months) of drug or alcohol abuse
    12. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
    13. Donation or loss of more than 400 mL blood within 8 weeks prior to first dose administration.
    14. Any medications prohibited (see table 2 in section 9.2) within 28 days prior to Day 0 visit and likely required during study treatment period
    15. History of clinically significant drug allergy to nucleoside/nucleotide analogs.
    16. History or current evidence of psychiatric illness, endocrine, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or other conditions that in the opinion of the investigator makes the patient unsuitable for the study. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening. No new therapies should be started within 28 days prior to the study that may confound the assessment of study drug safety.
    17. Participation in a clinical study in which an investigational drug, biologic, or device was received within 12 weeks prior to first dose administration.
    18. Pregnant/Breastfeeding women

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02533934

Contacts

Contact:   Rodney Rogers 415-514-6454 Rodney.Rogers@ucsf.edu

Locations

United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Rae Davis    415-514-3274    Rayshawnda.Davis@ucsf.edu
Principal Investigator: Peter Stock, MD, PhD
Sub-Investigator: Norah Terrault, MD
Sub-Investigator: Marion Peters, MD
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Nora Sabri    202-444-0183    Nora.M.Sabri@gunet.georgetown.edu
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robert Redfield, MD    410-706-4613    rredfield@ihv.umaryland.edu
Contact: Shyamasundaran Kottilil    410-706-8927    skottilil@ihv.umaryland.edu
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Christine Durand    410-614-5470    ChristineDurand@jhmi.edu
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Mary McLaughlin, RN, BSN    301-435-8001    MMCLAUGHLI@niaid.nih.gov
Contact: Maryellen McManus    301-326-9711    maryellen.mcmanus@nih.gov
Principal Investigator: Henry Masur, MD
United States, New York
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Allyson Coopersmith    212-241-0257    Allyson.Coopersmith@mountsinai.org
Principal Investigator: Shirish Huprikar, MD
Sub-Investigator: Sander Florman, MD
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Moury Minhaz    212-305-3839    mm3597@cumc.columbia.edu
Principal Investigator: Lorna Dove, MD
Sub-Investigator: Jean Emond, MD
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maryann Najdzinowicz    212-662-4007    maryann.najdzinowicz@uphs.upenn.edu
Principal Investigator: Emily Blumberg, MD
Sub-Investigator: Kim Olthoff, MD

Sponsors and Collaborators

University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Icahn School of Medicine at Mount Sinai
Columbia University
University of Pennsylvania
University of Maryland
Georgetown University
Johns Hopkins University
National Institutes of Health Clinical Center (CC)

Investigators

Principal Investigator: Peter Stock, MD, PhD University of California, San Francisco
Principal Investigator: Henry Masur, MD National Institutes of Health Clinical Center (CC)
More Information

More Information


Responsible Party: Peter Stock, Professor in Residence, University of California, San Francisco  
ClinicalTrials.gov Identifier: NCT02533934   History of Changes  
Other Study ID Numbers: 12044  
  1U01AI115714  
Study First Received: August 25, 2015  
Last Updated: December 2, 2016  
Individual Participant Data    
Plan to Share IPD: Undecided  

Keywords provided by Peter Stock, University of California, San Francisco:

HIV
Hepatitis C
Liver Disease
HCV Treatment
transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.