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Trial registered on ANZCTR
Registration number
ACTRN12618001340224p
Ethics application status
Submitted, not yet approved
Date submitted
6/08/2018
Date registered
9/08/2018
Date last updated
9/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to examine the tolerability and antiviral activity of switching to Biktarvy tablets taken once daily compared to baseline over 48 weeks in HIV-1 infected antiretroviral therapy (ART) experienced participants aged 55 years and older who are virologically suppressed on a current antiretroviral regimen (CAR).
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Scientific title
A pilot study to examine the tolerability and antiviral activity of switching to Biktarvy tablets taken once daily compared to baseline over 48 weeks in HIV-1 infected antiretroviral therapy (ART) experienced participants aged 55 years and older who are virologically suppressed on a current antiretroviral regimen (CAR) which includes a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI).
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Secondary ID [1]
295627
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IN-AU-380-4654
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Universal Trial Number (UTN)
U1111-1217-8664
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Trial acronym
BIO (Bictegravir In Older)
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Linked study record
This is the parent-study. There is no linked study
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Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus
308962
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Condition category
Condition code
Infection
307860
307860
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a 55 years and older cohort of a switch, open-labelled study to Biktarvy from current antiretroviral regimen with analysis of changes in viral load, CD4+ cell count and patient reported outcomes at week 48 compared to those at baseline.
Biktarvy is a fixed dose combination (FDC) tablet containing three medications: Bictegravir 50mg (BIC), Tenofovir Alafenamide 25mg (TAF) and Emtricitabine 200mg (FTC).
Participants who are 55 years and older will receive Biktarvy tablets administered orally, once daily without regard to food. The treatment period of this study is at least 48 weeks (approximately 11 months), not including the screening period which may last up to 30 days.
Subjects will be instructed to bring all study medication in the original container at each clinic visit for drug accountability. The Investigator or study coordinator will be responsible for maintaining accurate records for all study drug bottles dispensed and tablets returned. The inventory and dispensing logs must be available for study drug accountability
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Intervention code [1]
301944
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Examine the change in viral load after switching to Biktarvy compared with baseline using serum assay and data-linkage to medical records.
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Assessment method [1]
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Timepoint [1]
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Baseline and 48 Weeks after intervention commencement
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Primary outcome [2]
307054
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Examine the change in CD4 T-cell count after switching to Biktarvy compared with baseline using serum assay and data-linkage to medical records
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Assessment method [2]
307054
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Timepoint [2]
307054
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Baseline and 48 Weeks after intervention commencement
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Secondary outcome [1]
349885
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Composite secondary outcome evaluating quality of life and safety of the treatment group through Week 48. Quality of life and safety using the Short Form 36 Health Survey (SF-36) and HIV Symptoms Distress Module Index assessments Questionnaire.
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Assessment method [1]
349885
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Timepoint [1]
349885
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Secondary timepoint: Baseline and at 24 and 48 Weeks after intervention commencement
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Eligibility
Key inclusion criteria
1. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
2. Age 55 years and older.
3. Currently receiving an antiretroviral regimen which can consist of a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI) greater than or equal to 6 months preceding the screening visit.
4. HIV RNA less than 50 copies/mL at the screening visit.
5. Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence (as defined in Appendix 1) from screening, throughout the duration of the study period.
a) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing.
6. Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception (as described in Appendix 1) throughout the study period.
7. Male subjects must agree to refrain from sperm donation from first study drug dose until at least 90 days following the last study drug dose.
8. Currently on a stable regimen greater than or equal to 6 months preceding the Screening visit with documented plasma HIV-1 RNA less than 50 copies/mL for 6 months preceding the Screening visit
9. Have no documented or suspected resistance to TAF and FTC.
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies).
2. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
3. A history of or ongoing malignancy (including untreated carcinoma in-situ) other than
cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study.
4. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1.
5. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
6. Any known allergies to the excipients of BIC/TAF/FTC.
7. Females who are pregnant (as confirmed by positive serum pregnancy test).
8. Females who are breastfeeding.
9. Administration of any Prohibited Medication eg. Dofetilide, Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine and St. John’s Wort must be discontinues at least 30 days prior to the Day 1 Visit and the duration of the study.
10. Severe hepatic impairment and unstable liver disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary outcome of interest change in viral load from baseline to week 48 will be formally tested using the one-sample non-inferiority t-test under the assumption that “higher is bad”. Similarly, change in CD4 t cell count from baseline to week 48 will also be formally tested using the one-sample non-inferiority t-test under the assumption that “higher is good”.
The quality of life and safety index assessments will be in exploratory nature and will be described using summary statistics at baseline and at week 48. We will also use two sided one sample t-test to assess the difference between the two time points. All the analysis will be conducted using Statistical Software package SAS V9.0.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2018
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Actual
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Date of last participant enrolment
Anticipated
1/10/2019
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Actual
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Date of last data collection
Anticipated
1/10/2020
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
11491
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Taylor Square Private Clinic - Darlinghurst
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Recruitment postcode(s) [1]
23513
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2010 - Darlinghurst
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Funding & Sponsors
Funding source category [1]
300210
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Commercial sector/Industry
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Name [1]
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GILEAD SCIENCES
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Address [1]
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417 St Kilda Rd, Melbourne VIC 3004
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Country [1]
300210
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Taylor Square Private Clinic
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Address
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
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Country
Australia
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Secondary sponsor category [1]
299617
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None
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Name [1]
299617
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Address [1]
299617
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Country [1]
299617
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
301033
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Bellberry Human Research Ethics Committee
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Ethics committee address [1]
301033
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129 Glen Osmond Rd, Eastwood South Australia 5063
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Ethics committee country [1]
301033
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Australia
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Date submitted for ethics approval [1]
301033
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02/07/2018
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Approval date [1]
301033
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Ethics approval number [1]
301033
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Summary
Brief summary
The primary objective of this study is to examine the tolerability and antiviral activity of switching to Biktarvy from a current antiretroviral regimen (CAR) consisting of a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI) in HIV-1 infected antiretroviral therapy (ART) experienced subjects aged 55 years and older who are virologically suppressed as determined by the proportion of subjects with HIV-1 RNA greater than or equal to 50copies/mL at Week 48. The primary outcome of interest change in viral load from baseline to Week 48 will be formally tested under the assumption that “higher is bad”. Similarly change in CD4 t cell count from baseline to week 48 will also be formally tested under the assumption that “higher is good”.
The secondary objective is to evaluate quality of life and safety of the treatment group through Week 48. The secondary outcome of interest change in distress index assessments from baseline to Week 48 will be formally tested under the assumption that” no difference between the two time points”
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Robert Finlayson
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Address
85650
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Dr. Robert Finlayson
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
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Country
85650
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Australia
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Phone
85650
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61293316151
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Fax
85650
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61293315073
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Email
85650
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[email protected]
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Contact person for public queries
Name
85651
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Ms Ching Tan
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Address
85651
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Ching Tan
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
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Country
85651
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Australia
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Phone
85651
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61293316151
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Fax
85651
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61293315073
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Email
85651
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[email protected]
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Contact person for scientific queries
Name
85652
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Dr Robert Finlayson
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Address
85652
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Dr. Robert Finlayson
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
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Country
85652
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Australia
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Phone
85652
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61293316151
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Fax
85652
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61293315073
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Email
85652
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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