UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048446 |
|---|---|
| Receipt number | R000055212 |
| Scientific Title | The impact of switching to two-drug antiretroviral therapy on body weight and metabolic profiles: A randomized, open-label, two-parallel-group, multicenter trial. |
| Date of disclosure of the study information | 2022/07/25 |
| Last modified on | 2022/10/18 22:33:53 |
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Basic information
Public title
The impact of switching to two-drug antiretroviral therapy on body weight and metabolic profiles: A randomized, open-label, two-parallel-group, multicenter trial.
Acronym
The impact of switching to 2-drug antiretroviral therapy on body weight and metabolic profiles.
Scientific Title
The impact of switching to two-drug antiretroviral therapy on body weight and metabolic profiles: A randomized, open-label, two-parallel-group, multicenter trial.
Scientific Title:Acronym
The impact of switching to 2-drug antiretroviral therapy on body weight and metabolic profiles.
Region
| Japan |
Condition
Condition
Human immunodeficiency virus infection
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in body weight, body mass index, and lipid, glucose, and inflammatory profiles among individuals who switched to 2-drug regimen (DTG/3TC) compared with those who continued current 3-drug regimen (TAF/FTC+INSTI).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight from baseline to week 48
Key secondary outcomes
1)Changes in metabolic and inflammatory profiles (cholesterol, triglyceride, glucose, HbA1c, HOMA-IR, C-reactive protein, and CD4+/CD8+ ratio) from baseline to weeks 48 and 96.
2)Change in body weight from baseline to week 96
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Randomly assigned (1:1) to switch to 2-drug regimen (3TC/DTG) or continue the current 3-drug regimen (TAF/FTC + DTG).
Interventions/Control_2
Randomly assigned (1:1) to switch to 2-drug regimen (3TC/DTG) or continue the current 3-drug regimen (TAF/FTC/BIC).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Adults with HIV (PWH) who have chosen to participate in research based on their own understanding and wishes. Participants must be able to understand protocol requirements, instructions, and restrictions.
2)PWH with hepatitis B virus (HBV) immunity through natural infection (anti-HBc positive, anti-HBs positive, and HBsAg negative).
3)PWH with HBV immunity following complete HBV vaccination (anti-HBs >10 mIU/mL, anti-HBc negative, and HBsAg negative).
4)PWH on 3-drug ART who achieved viral suppression (HIV-1 RNA <50 copies/mL) for at least 12 months prior to inclusion.
Key exclusion criteria
1)Individuals with active opportunistic illnesses.
2)Any history of detection of major NRTI or INSTI mutations.
3)Any history of virologic failure (HIV-1 RNA >200 copies/mL) for which salvage therapy were required.
4)Individuals who had failed to HIV pre-exposure prophylaxis (PrEP).
5)Individuals with untreated syphilis (or until 7 days after completion of the treatment of syphilis).
6)PWH with creatine clearance of <30 mL/min/1.73m2, liver cirrhosis, malignancy, or use of cancer chemotherapeutic/immunosuppressive agents.
7)PWH with ALT >= 5 times the upper limit of normal (ULN), ALT >= 3 times ULN, and bilirubin >= 1.5 times ULN.
8)PWH with HBV infection (positive for HBsAg or HBV-DNA), history of nucleos(t)ide analogue therapy for HBV, or history of chronic HBV infection.
9)Individuals who receive or anticipate receiving treatment for hepatitis C during the study period.
10)Individuals who receive insulin therapy, SGLT-2 inhibitor, or GLP-1 receptor agonist.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Hatakeyama |
Organization
Jichi Medical University Hospital
Division name
Division of Infectious Diseases
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotuke-shi, Tochigi 329-0498 Japan
TEL
0285-58-7498
hatakeyamas@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Minami |
Organization
Jichi Medical University Hospital
Division name
Division of Infectious Diseases
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotuke-shi, Tochigi 329-0498 Japan
TEL
0285-58-7580
Homepage URL
kens37mi@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Foundation for Development of the Community
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotuke-shi, Tochigi 329-0498 Japan
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院 Jichi Medical University Hospital
自治医科大学附属さいたま医療センター Jichi Medical University Saitama Medical Center
東京都立大久保病院 Tokyo Metropolitan Ohkubo Hospital
東京都立多摩総合医療センター Tokyo Metropolitan Tama Medical Center
済生会宇都宮病院 Saiseikai Utsunomiya Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 25 | 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
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055212
| 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 |
