The TAP Study: Treating People Who Inject Drugs in Community-Based

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

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 (SOF + LDP). It will also measure the effectiveness of using a social network-based approach ("bring your friends") to reduce HCV incidence among PWID. Participants will initially be sourced from the Burnet Institute's existing SuperMIX cohort (N= 757). This cohort comprises PWID followed for between two and six years (median=1057 days), of whom 299 have chronic HCV infection. The HCV genotype distribution in the SuperMIX cohort is: HCV-1 (55%); HCV-3 (40%) and HCV-6 (<5%).

Participants will be randomly allocated to three groups:

Group 1: Primary (n=40) and secondary (n=100) participants will receive supportive care only.

Group 2: Primary participants (n=40) will be treated with SOF + LDP for 12 weeks. Secondary participants (n=100) will receive supportive care only.

Group 3: Primary (n=40) and secondary participants with chronic HCV infection (n=50%*100) will be treated with SOF + LDP for 12 weeks. Participants in Group C who have evidence of HCV re-infection will be offered re-treatment with SOF + LDP for 12 weeks.

Treatment participants will have a clinical review, questionnaire and blood sample collected at baseline, weeks 4, 8 and 12 (end-of-treatment), and at weeks 12 (SVR12), 24 (SVR24), 36, 48, 60 and 72 post-treatment. Non-treatment participants will have a clinical review, questionnaire and blood sample collected at baseline and weeks 12, 24, 36, 48, 60, 72 and 84. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02363517
Study type	Interventional
Source	Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Contact	Dr Joseph Doyle
Phone	+61392822111
Email	j.doyle@burnet.edu.au
Status	Recruiting
Phase	Phase 3
Start date	February 2015
Completion date	December 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms