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Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World (SHARED)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Partners in Health
Sponsor:
Information provided by (Responsible Party):
Partners in Health
ClinicalTrials.gov Identifier:
NCT02964091
First received: November 3, 2016
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

Condition Intervention Phase
Chronic Hepatitis C Drug: sofosbuvir/ledipasvir Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

Resource links provided by NLM:


Further study details as provided by Partners in Health:

Primary Outcome Measures:
  • Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment [ Time Frame: After study completion (24 weeks) ]
    To determine the hepatitis C virus (HCV) antiviral efficacy of sofosbuvir/ledipasvir (SOF/LDV) fixed-dose combination (FDC) as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda.

  • Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment, with limited lab monitoring [ Time Frame: After study completion (24 weeks) ]
    To determine the HCV antiviral efficacy of SOF/LDV FDC, as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12), with limited lab monitoring in Rwanda.

  • Proportion of participants with a new grade 3 or 4 adverse event or premature study drug discontinuation due to an adverse event. [ Time Frame: After study completion (24 weeks) ]
    To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda


Secondary Outcome Measures:
  • A set of minimum required monitoring tests [ Time Frame: After study completion (24 weeks) ]
  • Distribution of HCV genotypes subtypes among participants [ Time Frame: After study completion (24 weeks) ]
  • SVR12, stratified by genotypic subtype [ Time Frame: After study completion (24 weeks) ]
  • Basic demographic and clinical characteristics of patients referred for HCV treatment [ Time Frame: After study completion (24 weeks) ]
  • Adherence to SOF/LDV measured by pill count [ Time Frame: After 12 weeks medication therapy ]
  • Proportion of participants with virologic failure [ Time Frame: After study completion (24 weeks) ]
  • Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment [ Time Frame: After study completion (24 weeks) ]
  • Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment [ Time Frame: After 12 weeks of medication therapy ]
  • Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey [ Time Frame: After study completion (24 weeks) ]
    To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda


Estimated Enrollment: 300
Study Start Date: October 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Harvoni
sofosbuvir/ledipasvir once daily for 12 weeks
Drug: sofosbuvir/ledipasvir
Other Name: Harvoni

Detailed Description:
This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.
  Eligibility

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

Inclusion Criteria:

  • patients that are willing and able to provide written informed consent
  • age ≥ 18 years
  • HCV RNA ≥ 103 IU/mL
  • HCV genotype 1 or 4
  • screening ultrasound excluding hepatocellular carcinoma (HCC)
  • acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)
  • general good health
  • ability to comply with study procedures
  • HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA < 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL

Exclusion Criteria:

  • current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
  • active tuberculosis
  • other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder
  • active Hepatitis B infection
  • difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence
  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: NCT02964091

Contacts
Contact: Neil Gupta, MD +250785719897 ngupta@pih.org
Contact: Jennifer I Van Nuil, PhD +250786419185 jilovannuil@pih.org

Locations
Rwanda
Rwanda Military Hospital Recruiting
Kanombe, Kigali, Rwanda, 00000
Contact: Jules Kabahizi, MD    250788824874    jukabahizi@yahoo.fr   
Sponsors and Collaborators
Partners in Health
Investigators
Principal Investigator: Neil Gupta, MD Partners in Health
Principal Investigator: Jules Kabahizi, MD Rwanda Military Hospital
Principal Investigator: Aimable Mbituyumuremyi, MD Rwanda Biomedical Center
Principal Investigator: Philip Grant, MD Stanford University
Principal Investigator: Claude M Muvunyi, MD University of Rwanda
  More Information

Responsible Party: Partners in Health
ClinicalTrials.gov Identifier: NCT02964091     History of Changes
Other Study ID Numbers: SHARED 092415
Study First Received: November 3, 2016
Last Updated: November 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Partners in Health:
Hepatitis C Virus
sofosbuvir/ledipasvir
Efficacy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 21, 2017