UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038177 |
|---|---|
| Receipt number | R000043518 |
| Scientific Title | Efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy in virologically suppressed HIV-infected patients |
| Date of disclosure of the study information | 2019/10/05 |
| Last modified on | 2023/04/05 09:29:23 |
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Basic information
Public title
Efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy in virologically suppressed HIV-infected patients
Acronym
Efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy in virologically suppressed HIV-infected patients
Scientific Title
Efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy in virologically suppressed HIV-infected patients
Scientific Title:Acronym
Efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy in virologically suppressed HIV-infected patients
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of antiretoviral therapy after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV-infected patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy for maintenance of virological suppression in HIV-infected patients 48 weeks after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy.
Key secondary outcomes
Efficacy for improvement of renal function and bone metabolism markers, rate of new HBV infection 48 weeks after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) HIV-infected patients who visited Kyushu-university hospital from January 1, 2013 to December 31, 2018.
(2)Patients after switching TDF to TAF containing ART regimens in which virologically suppressed (HIV RNA< 20 copies/mL) for at least 6 months
(3)Patients remain on the same third agent after switching to TAF/FTC containing regimen
(4)Patients received an explanation of the study protocol and gave written informed consent.
(5)Patients whose age is over 20 on informed consent acquisition date
Key exclusion criteria
Patients are inadequate to include in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Murata |
Organization
Kyushu University Hospital
Division name
Department of General internal medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5909
mmurata@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Murata |
Organization
Kyushu University Hospital
Division name
Department of General internal medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5909
Homepage URL
mmurata@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Department of General internal medicine
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
Department of General internal medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Ho
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 05 | 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
| Delay expected |
Results Delay Reason
Analysis in progress
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
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study design: Single arm, observational study.
We assess the efficacy and safety of antiretoviral therapy after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV-infected patients.
Iclusion criteria
(1) HIV-infected patients who visited Kyushu-university hospital from January 1, 2013 to December 31, 2018.
(2)Patients after switching TDF to TAF containing ART regimens in which virologically suppressed (HIV RNA< 20 copies/mL) for at least 6 months
(3)Patients remain on the same third agent after switching to TAF/FTC containing regimen
Primary endpoint:
Efficacy 48 weeks after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy for maintenance of virological suppression in HIV-infected patients.
Key secondary endpoints:
Efficacy for improvement of renal function and bone metabolism markers, rate of new HBV infection 48 weeks after switching from tenofovir disoproxil fumarate to tenofovir alafenamide containing antiretroviral therapy.
Management information
Registered date
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043518
