- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363517
The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach (TAP)
The Treatment And Prevention (TAP) Study: Treating People Who Inject Drugs (PWID) in Community-based Settings Using a Social Network Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Victoria
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Burnet Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
SECONDARY PARTICIPANTS INCLUSION AND EXCLUSION CRITERIA
Study INCLUSION criteria for primary participants are as follows:
- 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.
EXCLUSION criteria for all primary participants are as follows:
- Testing positive for HIV
- History of, or current, decompensated liver disease
- Testing positive for HBsAg
- HCC
- Women who are pregnant or breastfeeding, or men with female partners who are pregnant at screening or baseline, or who were pregnant in the six months prior to screening
- Already enrolled in the TAP Study as a secondary participant (see below)
- Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant;
- Use of concomitant medications.
Additional EXCLUSION criteria for primary participants with HCV genotypes 2-6:
- Increased baseline risk for anaemia (e.g., a history of thalassemia, spherocytosis, history of GI bleeding), or for whom anaemia would be medically problematic;
- Documented or presumed coronary artery disease or cerebrovascular disease if, in the judgment of the investigator, an acute decrease in haemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated.
SECONDARY PARTICIPANTS INCLUSION AND EXCLUSION CRITERIA
The INCLUSION criteria for secondary participants are as follows:
- Is nominated by a primary participant as a current injecting partner (i.e., has engaged in IDU with a primary participant in the previous six months)
- Willing and able to provide written informed consent.
There are no exclusion criteria for secondary participants who are not receiving HCV therapy in this protocol:
EXCLUSION criteria for treated secondary participants (i.e., those in Group C who are HCV positive) are as follows:
- History of, or current, decompensated liver disease
- Women who are pregnant or breastfeeding, or men with female partners who are pregnant at screening or baseline, or who were pregnant in the six months prior to screening
- Testing positive for HIV
- Testing positive for HBsAg
- HCC
- Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant
- Use of concomitant medications.
Additional EXCLUSION criteria for secondary participants with HCV genotypes 2-6:
- Increased baseline risk for anaemia (e.g. a history of thalassemia, spherocytosis, history of GI bleeding) or for whom anaemia would be medically problematic
- Documented or presumed coronary artery disease or cerebrovascular disease if, in the judgment of the investigator, an acute decrease in haemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group A
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. |
|
Active Comparator: Group B
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. |
SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
Other Names:
|
Active Comparator: Group C
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.
|
SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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).
|
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
Time Frame: Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
|
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
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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
Time Frame: Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
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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
Time Frame: Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)
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Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in levels of injecting risk behaviours among participants following HCV treatment, as measured by self-reported frequency of risky injecting behaviours among participants
Time Frame: Weeks 12, 24, 36, 48, 60, 72 and 84
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Weeks 12, 24, 36, 48, 60, 72 and 84
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Changes to Quality of Life (QoL) among treated participants versus non-treated participants, as measured by self-reported responses to validated QoL scales
Time Frame: Weeks 12, 24, 36, 48, 60, 72 and 84
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Weeks 12, 24, 36, 48, 60, 72 and 84
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The prevalence of HCV resistance associated variants among treated participants who do not achieve SVR12
Time Frame: At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment
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At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment
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Changes in the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants
Time Frame: Up to 84 weeks
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Up to 84 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Prof Margaret Hellard, Burnet Institute
- Principal Investigator: Prof Alexander Thompson, St Vincent's Hospital Melbourne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Substance-Related Disorders
- Substance Abuse, Intravenous
- Hepatitis
- Hepatitis C
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
Other Study ID Numbers
- MacfarlaneBIMRPH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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