UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041113 |
|---|---|
| Receipt number | R000045929 |
| Scientific Title | A study evaluating effectiveness, safety, and pharmacokinetics of the Bictegravir/Emtricitabine/Tenofovir alafenamide single-tablet regimen in treatment-experienced elderly Japanese subjects living with HIV |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2023/07/18 09:45:36 |
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Basic information
Public title
Safety analysis of anti-retroviral drug: Biktarvy for Japanese elderly patients.
Acronym
Safety analysis of Biktarvy.
Scientific Title
A study evaluating effectiveness, safety, and pharmacokinetics of the Bictegravir/Emtricitabine/Tenofovir alafenamide single-tablet regimen in treatment-experienced elderly Japanese subjects living with HIV
Scientific Title:Acronym
A study of the Biktarvy targeting elderly Japanese subjects living with HIV.
Region
| Japan |
Condition
Condition
HIV-1 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effectiveness and safety of B/F/TAF among treatment-experienced elderly Japanese male living with HIV with suppressed viral load in the real world setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate effectiveness as the ratio of the patients with suppressed viral load (< 50c/mL).
Key secondary outcomes
The secondary endpoint includes virologic failure as viral load of >200 copies /mL at weeks 24 and 48 and emergence of drug resistance, safety and tolerability over 48 weeks, and drug concentrations (peak and trough) at over 4 weeks of the treatment.
For subgroup of 10 patients who undergo intensive 24-hr PK monitoring, PK parameters such as AUC, Cmax, Tmax will be calculated.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study is a single-center prospective one-arm study. This study will enroll 100 HIV-1 infected treatment-experienced patients with suppressed viral load. Antiretroviral therapy of the patients will be switched to B/F/TAF after enrollment and will be followed for at least 48 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Japanese male with HIV-1infection with age of 50 years or older
(2)With more than 30 ml/min creatinine clearance. BMI (weight (kg) /height (m)2) 18 to <35
(3)No known INSTI resistance
(4)No prior virologic failure on INSTI
(5)Be able to take medication in the morning
(6)Provide written informed consent to the study
Key exclusion criteria
(1)Liver cirrhosis
(2)Concurrent medication which might interact with BIC, such as metformin
(3)Patients whose physicians consider the study enrollment inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Watanabe |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
kwatanab@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Watanabe |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
kwatanab@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Management,Management and Planning Bureau National Center for Global Health and Medicine
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人国立国際医療研究センター病院（東京都）
National Center for Global Health and Medicine
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045929
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
