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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017975
Receipt No. R000020777
Scientific Title antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Date of disclosure of the study information 2015/06/19
Last modified on 2018/12/25

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Basic information
Public title antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Acronym ART intensified by MVC with early HIV-1 infection
Scientific Title antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Scientific Title:Acronym ART intensified by MVC with early HIV-1 infection
Region
Japan

Condition
Condition HIV-1 infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess efficacy and safety of standard ART regimen intensified with maraviroc, compared with historical standard triple-drug ART regimen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of patients achieving plasma viral load less than 50 copies/mL at week 48
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intensification with maraviroc for 24 weeks on standard ART regimen during early HIV-1 infection
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) HIV-1 infection with detected HIV-1 RNA
2) Incomplete HIV-1 Western blot on entry, or negative HIV-1 antibody within previous 1 year of entry
3) Written informed consent in Japanese is obtained
4) R5 HIV-1 as determined using the genotypic assay
Key exclusion criteria 1) coronary diseases: unstable angina or history of acute myocardial infarction within 6 months before entry
2) Viral hepatitis (HBV,HCV)
3) Any verified Grade 4 laboratory abnormality (excluding abnormal lipid metabolism)
4)Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
5) Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method
6)Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2014] in the Screening result or, if known, any historical resistance test results
7) Women who are pregnant or sexually active without effective contraception
8) Subjects whom investigators consider to be inappropriate to enroll in the study





Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Shirasaka
Organization National Hospital Organization Osaka National Hospital
Division name AIDS Medical Center
Zip code
Address 2-1-14 Houenzaka, Chuo-ku, Osaka city, Osaka Pref., Japan
TEL 81-6-6942-1331
Email sirasaka@onh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Nagasawa
Organization National Hospital Organization Osaka National Hospital
Division name AIDS Medical Center
Zip code
Address 2-1-14 Houenzaka, Chuo-ku, Osaka city, Osaka Pref., Japan
TEL 81-6-6942-1331
Homepage URL
Email nagasawa@onh.go.jp

Sponsor
Institute National Hospital Organization Osaka National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H26-NHO_AIDS-02
Org. issuing International ID_1 National Hospital Organization
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 06 Month 19 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 19 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020777

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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