Clinical Trials

MainTitle

Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

This study is ongoing, but not recruiting participants.
Sponsor
National Institutes of Health Clinical Center (CC)


Information provided by (Responsible Party)
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier
NCT02339038

First received: January 14, 2015
Last updated: June 15, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

Background:

  • Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia.


  • Objectives:
  • To see if people can be treated for Hepatitis C safely and successfully in community-based health centers.


  • Eligibility:
  • Adults who need treatment for chronic Hepatitis C infection.


  • Design:
  • Participants will be screened with blood tests. Their current medicines will be reviewed.
  • Participants will give researchers access to their medical records. Researchers will follow participants through these records.
  • Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits.
  • Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly.
  • Participants will have monthly follow-up visits for up to 3 months after they finish their medicine.
  • Participants will have yearly follow-up visits with their care provider for up to 10
years.

Condition Intervention Phase
HCV HIV

Drug : Ledipasvir 90 mg and Sofosbuvir 400 mg
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures

  • Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs [ Time Frame: At least 12 weeks after completion of medication ]
    The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).

Enrollment: 600
Study Start Date: January 7, 2015
Estimated Study Completion Date: August 1, 2025
Estimated Primary Completion Date: June 15, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Standard of Care
Standard of care treatment using Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination by mouth daily for 2, 3, or 6 months
Drug: Ledipasvir 90 mg and Sofosbuvir 400 mg

Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines

Other Name: Harvoni

Detailed Description:

Treatment for hepatitis C has been revolutionized in the last 2 years with the advent of combination antiviral therapy yielding high cure rates; although, the long term effects of treatment remain uncertain. Use of these medications has been limited to clinical trial settings typically by highly specialized care teams in tertiary care hospitals. As the prevalence of hepatitis C is significant, there exists a significant imbalance between patients who require treatment and specialists who provide treatment. Success rates in treatment of hepatitis C by primary care doctors or physician extenders, such as nurse practitioners or physician assistants, is largely unknown.
As such, we propose the first community-based, large scale, longitudinal study of directly acting antiviral (DAA)-based treatment for chronic hepatitis C, set in the District of Columbia. Within this study, approximately 600 HCV genotype 1 monoinfected and HCV/HIV coinfected subjects will be treated with ledipasvir/sofosbuvir (90 mg/400 mg) fixed dosed combination for 8-24 weeks, based on the medication labeling instructions, and followed for both immediate (SVR12) and long term (comorbid disease, cirrhosis, hepatocellular carcinoma, transplantation and mortality) outcomes over a 10 year study period. The study will be conducted exclusively in the District of Columbia clinics associated with the NIH DC Partnership for AIDS/HIV Progress (DC PFAP), which serves a population comprised primarily of minorities, with a high degree of negative predictors of treatment response. In this study, participants will be assigned to treatment either by (1) an ID or hepatology specialist, (2) primary care provider, or (3) physician extender. Please see Figure 1 study schema for an approximate distribution of subjects. Each of these provider groups will undergo uniform training on treatment of hepatitis C and management of adverse events prior to initiation of study. All subjects will sign informed consent and agree to treatment and follow up phases of the study. During the course of the study, subjcts will be clinically evaluated based on American Association for the Study of Liver Diseases (AASLD)/ the Infectious Diseases Society of America (IDSA) guidelines for the management of hepatitis C. Clinical data from subjects will be captured in a city wide cohort database, which will store guideline-driven data points from each clinic visit within the network.
Through this trial we will explore the efficacy of managing hepatitis C subjects with directly acting antiviral therapy in an urban, community-based setting, and investigate the effect of provider type (specialist, primary care, or physician extender) on treatment outcome. We will detail the safety and tolerability of this treatment. We will assess variability in treatment outcomes between monoinfected and HIV-coinfected subjects. Finally, we will evaluate the public health impact of large-scale treatment of HCV infected subjects in preventing long-term clinical outcomes. As the first interferon (IFN)- and ribavirin (RBV)-free, urban community-based treatment utilizing new standard of care criteria, this study will serve as a model for implementation of similar practice patterns globally.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

  • INCLUSION CRITERIA:
    1. Male or female at least 18 years of age at time of screening who is determined to be eligible based on evaluation by a treating provider,
    2. Documentation of genotype 1 (GT-1) infection, liver fibrosis staging by any AASLD/IDSA guideline approved measurement, and HIV status determination.
    3. Chronic HCV genotype-1 infection prior to study enrollment. Chronic HCV-infection is defined as the following: positive for anti-HCV Ab or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening
    4. Compensated liver disease, both with and without cirrhosis, as determined clinically by referring provider
    5. If coinfected with HIV, stable HIV disease as determined by a treating provider
    6. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.

  • Exclusion Criteria:
  • Women who are pregnant or breastfeeding
  • Screening laboratory analyses showing any of the following abnormal laboratory results:
    • Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min as estimated by the Modification of Diet in Renal Disease (MDRD) equation (utilized by LabCorp):

    • eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)
  • Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
  • Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.

    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: NCT02339038

    Locations

    United States, District of Columbia
    Unity Health Care, Inc./DC General
    Washington, D.C., District of Columbia, United States, 20002
    Family Medical and Conseling Services
    Washington, D.C., District of Columbia, United States, 20020

    Sponsors and Collaborators

    National Institutes of Health Clinical Center (CC)

    Investigators

    Principal Investigator: Henry Masur, M.D. National Institutes of Health Clinical Center (CC)
    More Information

    More Information


    Responsible Party: National Institutes of Health Clinical Center (CC)  
    ClinicalTrials.gov Identifier: NCT02339038   History of Changes  
    Other Study ID Numbers: 15N064  
      15-CC-N064  
    Study First Received: January 14, 2015  
    Last Updated: June 15, 2017  
    Individual Participant Data    
    Plan to Share IPD: No  

    Studies a U.S. FDA-regulated Drug Product: Yes  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by National Institutes of Health Clinical Center (CC):

    Community Based Research
    Hepatitis C Virus and Human Immunodeficiency Virus
    Ledipasvir/Sofosbuvir
    Fixed Dose Combination
    Sustained Viral Response

    Additional relevant MeSH terms:
    Hepatitis
    Hepatitis C
    Hepatitis, Chronic
    Hepatitis C, Chronic
    Coinfection
    Sofosbuvir
    Ledipasvir

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.