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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).
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).
Secondary ID [1] 295627 0
IN-AU-380-4654
Universal Trial Number (UTN)
U1111-1217-8664
Trial acronym
BIO (Bictegravir In Older)
Linked study record
This is the parent-study. There is no linked study

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus 308962 0
Condition category
Condition code
Infection 307860 307860 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 301944 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306838 0
Examine the change in viral load after switching to Biktarvy compared with baseline using serum assay and data-linkage to medical records.
Timepoint [1] 306838 0
Baseline and 48 Weeks after intervention commencement

Primary outcome [2] 307054 0
Examine the change in CD4 T-cell count after switching to Biktarvy compared with baseline using serum assay and data-linkage to medical records
Timepoint [2] 307054 0
Baseline and 48 Weeks after intervention commencement
Secondary outcome [1] 349885 0
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.
Timepoint [1] 349885 0
Secondary timepoint: Baseline and at 24 and 48 Weeks after intervention commencement

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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11491 0
Taylor Square Private Clinic - Darlinghurst
Recruitment postcode(s) [1] 23513 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300210 0
Commercial sector/Industry
Name [1] 300210 0
GILEAD SCIENCES
Country [1] 300210 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Taylor Square Private Clinic
Address
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
Country
Australia
Secondary sponsor category [1] 299617 0
None
Name [1] 299617 0
Address [1] 299617 0
Country [1] 299617 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301033 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 301033 0
Ethics committee country [1] 301033 0
Australia
Date submitted for ethics approval [1] 301033 0
02/07/2018
Approval date [1] 301033 0
Ethics approval number [1] 301033 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85650 0
Dr Robert Finlayson
Address 85650 0
Dr. Robert Finlayson
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
Country 85650 0
Australia
Phone 85650 0
61293316151
Fax 85650 0
61293315073
Email 85650 0
robfin@tspc.com.au
Contact person for public queries
Name 85651 0
Ching Tan
Address 85651 0
Ching Tan
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
Country 85651 0
Australia
Phone 85651 0
61293316151
Fax 85651 0
61293315073
Email 85651 0
ching@tspc.com.au
Contact person for scientific queries
Name 85652 0
Robert Finlayson
Address 85652 0
Dr. Robert Finlayson
Taylor Square Private Clinic
393 Bourke Street,
Darlinghurst, New South Wales, 2010
Australia
Country 85652 0
Australia
Phone 85652 0
61293316151
Fax 85652 0
61293315073
Email 85652 0
robfin@tspc.com.au

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

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