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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029667
Receipt No. R000033901
Scientific Title Retreatment for HIV facial lipoatrophy
Date of disclosure of the study information 2017/10/23
Last modified on 2019/04/26

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Basic information
Public title Retreatment for HIV facial lipoatrophy
Acronym Retreatment for HIV facial lipoatrophy
Scientific Title Retreatment for HIV facial lipoatrophy
Scientific Title:Acronym Retreatment for HIV facial lipoatrophy
Region
Japan

Condition
Condition HIV facial lipoatrophy
Classification by specialty
Infectious disease Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of safety and efficacy of repetitive treatment to HIV facial lipoatrophy after initial plastic surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes quantitative and qualitative evaluation of the facial soft tissue at 48 weeks
Key secondary outcomes

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
Maneuver
Interventions/Control_1 dermal filler (hyaluronic acid) administeration
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 well controlled HIV infection
Key exclusion criteria platelet count lower than 50000/mm3
pregnancy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Oka
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1, Toyama, Shinjuku, Tokyo
TEL +81-3-3202-7181
Email oka@acc.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihisa Tsukada
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1, Toyama, Shinjuku, Tokyo
TEL +81-3-3202-7181
Homepage URL
Email ktsukada@acc.ncgm.go.jp

Sponsor
Institute AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 23 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 Terminated
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
2017 Year 03 Month 24 Day
Anticipated trial start date
2017 Year 10 Month 23 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 23 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033901

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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