UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Title of the study (Brief title)	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	Takuma Shirasaka
Organization	National Hospital Organization Osaka National Hospital
Division name	AIDS Medical Center
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	Yoko Nagasawa
Organization	National Hospital Organization Osaka National Hospital
Division name	AIDS Medical Center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020777