UMIN-CTR Clinical Trial

Basic information
Public title	Plastic Surgery for HIV facial lipoatrophy
Acronym	Plastic Surgery for HIV facial lipoatrophy
Scientific Title	Plastic Surgery for HIV facial lipoatrophy
Scientific Title:Acronym	Plastic Surgery 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 plastic surgery approach to HIV facial lipoatrophy
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	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	autologous fat transplantation
Interventions/Control_2	dermal filler (hyaluronic acid) administeration
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
Last 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
1st 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	2015 Year 12 Month 28 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	Completed
Date of protocol fixation	2014 Year 04 Month 21 Day
Date of IRB	2014 Year 04 Month 21 Day
Anticipated trial start date	2014 Year 04 Month 21 Day
Last follow-up date	2018 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	2015 Year 12 Month 28 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/icdr_e/ctr_view.cgi?recptno=R000023501