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The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach

NCT02363517 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2018-04-10

No results posted yet for this study

Summary

This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a social network-based approach to reduce HCV incidence among PWID.

Conditions

  • Hepatitis C
  • Drug Abuse, Intravenous

Interventions

DRUG

Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)

SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.

Sponsors & Collaborators

  • St Vincent's Hospital Melbourne

    collaborator OTHER

  • Macfarlane Burnet Institute for Medical Research and Public Health Ltd

    lead OTHER

Principal Investigators

  • Prof Margaret Hellard · Burnet Institute

  • Prof Alexander Thompson · St Vincent's Hospital Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02363517 on ClinicalTrials.gov