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

NCT02363517 | Unknown Phase 3 DMC

• 1 other identifier: MacfarlaneBIMRPH
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatitis; Viral; Non-A; Non-B; Parenterally-Transmitted

Outcome Measures

Primary Outcomes (4)

• The efficacy of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates

  Change in sustained viral response rates at weeks 12 and 24 post-treatment. Participant retention rate at weeks 4, 8 and 12 (end of treatment).

• The effectiveness of treating PWID on rates of HCV primary infection and reinfection among their social networks, as measured by HCV incidence rates among primary and secondary participants

  Hypothesis: Offering HCV treatment to PWID will lead to a lower incidence of transmission of HCV from primary participants to their injecting partners, compared to not treating any PWID.

  Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84

• The effectiveness of treating PWID using a "bring your friends" strategy on rates of HCV primary infection and reinfection, as measured by HCV incidence rates among participants

  Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84

• The feasibility of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates and participant retention

  Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)

Secondary Outcomes (4)

• Changes in levels of injecting risk behaviours among participants following HCV treatment, as measured by self-reported frequency of risky injecting behaviours among participants

  Weeks 12, 24, 36, 48, 60, 72 and 84

• Changes to Quality of Life (QoL) among treated participants versus non-treated participants, as measured by self-reported responses to validated QoL scales

  Weeks 12, 24, 36, 48, 60, 72 and 84

• The prevalence of HCV resistance associated variants among treated participants who do not achieve SVR12

  At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment

• Changes in the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants

  Up to 84 weeks

Study Arms (3)

Group A

NO INTERVENTION

Primary (n=40) and secondary (n=100) participants will receive supportive care only (includes a clinical review, questionnaire and blood sample collected at baseline and weeks 12, 24, 36, 48, 60, 72 and 84). Participants with HCV not allocated to treatment arms will receive deferred treatment at the end of the follow-up period.

Group B

ACTIVE COMPARATOR

Primary participants (n=40) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) for 12 weeks. Secondary participants (n=100) will receive supportive care only. Participants with HCV not allocated to treatment arms will receive deferred treatment at the end of the follow-up period.

Drug: Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)

Group C

ACTIVE COMPARATOR

Primary (n=40) and secondary participants with chronic HCV infection (approx. n=50%\*100) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (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.

Drug: Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)

Interventions

Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) DRUG

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

Also known as: Standard of care

Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Current PWID (i.e., injected any drug at least once during the previous six months);
• Evidence of chronic HCV infection (detectable plasma HCV RNA viral load above 1000 IU/ml on two occasions ≥ 6 months apart)
• Willing and able to provide written informed consent.
• Subjects must have the following laboratory parameters at screening:
• ALT \<10 times the upper limit of normal (ULN)
• AST \<10 times ULN
• Haemoglobin ≥12g/dL for males, ≥11g/dL for female subjects
• INR ≤1.5 times ULN unless is stable on an anticoagulant regimen affecting INR
• Albumin ≥3g/dL
• Direct bilirubin ≤1.5 times ULN
• Creatinine clearance (CLcr) ≥60mL/min, as calculated by the Cockcroft-Gault Equation.
• Testing positive for HIV
• History of, or current, decompensated liver disease
• Testing positive for HBsAg
• HCC

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• St Vincent's Hospital Melbourne: collaborator

Study Sites (1)

Burnet Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Substance Abuse, Intravenous; Hepatitis

Interventions

Sofosbuvir; Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Prof Margaret Hellard

  Burnet Institute

  PRINCIPAL INVESTIGATOR

• Prof Alexander Thompson

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Joseph Doyle

CONTACT

+61392822111; j.doyle@burnet.edu.au

Dr Brendan Quinn

CONTACT

+61392822111; brendanq@burnet.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

AU (1)