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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041113
Receipt No. 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 2020/07/27

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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
Email 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
Email kwatanab@acc.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
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
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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