Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02363517




Registration number
NCT02363517
Ethics application status
Date submitted
21/12/2014
Date registered
16/02/2015
Date last updated
10/04/2018

Titles & IDs
Public title
The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach
Scientific title
The Treatment And Prevention (TAP) Study: Treating People Who Inject Drugs (PWID) in Community-based Settings Using a Social Network Approach
Secondary ID [1] 0 0
MacfarlaneBIMRPH
Universal Trial Number (UTN)
Trial acronym
TAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Drug Abuse, Intravenous 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)

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.

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.


Treatment: Drugs: Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)
SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
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).
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)
Secondary outcome [1] 0 0
Changes in levels of injecting risk behaviours among participants following HCV treatment, as measured by self-reported frequency of risky injecting behaviours among participants
Timepoint [1] 0 0
Weeks 12, 24, 36, 48, 60, 72 and 84
Secondary outcome [2] 0 0
Changes to Quality of Life (QoL) among treated participants versus non-treated participants, as measured by self-reported responses to validated QoL scales
Timepoint [2] 0 0
Weeks 12, 24, 36, 48, 60, 72 and 84
Secondary outcome [3] 0 0
The prevalence of HCV resistance associated variants among treated participants who do not achieve SVR12
Timepoint [3] 0 0
At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment
Secondary outcome [4] 0 0
Changes in the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants
Timepoint [4] 0 0
Up to 84 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Burnet Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02363517
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Margaret Hellard
Address 0 0
Burnet Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr Joseph Doyle
Address 0 0
Country 0 0
Phone 0 0
+61392822111
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02363517