UMIN-CTR Clinical Trial

Basic information
Public title	Research for evaluation of efficacy and safety of DAA therapy in HIV/HCV co-infected patients disorders
Acronym	Research of DAA therapy in HIV/HCV co-infected patients
Scientific Title	Research for evaluation of efficacy and safety of DAA therapy in HIV/HCV co-infected patients disorders
Scientific Title:Acronym	Research of DAA therapy in HIV/HCV co-infected patients
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim this study to evaluate efficacy and safety of approved DAA treatment with ledipasivir and sofosbuvir for HCV GT1 and sofosbuvir and ribavirin for HCV GT2 in HIV/HCV co-infected patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Successful treatment is defined as sustained virological response at 12 weeks after the end of treatment.
Key secondary outcomes	Evaluation of safety: Grade 3/4 adverse events and discontinuation of study drugs.

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	Medicine
Interventions/Control_1	Patients with HCV genotype 1 (GT1) or serotype 1 receive ledipasvir (90 mg) plus sofosbuvir (400 mg) in a fixed-dose table (Product name: Harvoni) for 12 weeks.
Interventions/Control_2	Patients with HCV GT2 received sofosbuvir (400 mg, Product name: Sobarudi) plus weight-based ribavirin for 12 weeks according to the approved method of administration.
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	Adult patients who regularly visit our hospital. Patients who infect with HIV-1 and HCV Blood HCV-RNA is positive in the time of enrollment. Patients who are receiving antiretroviral regimen for more than 8 weeks and to have evidence of HIV-1 viral suppression (HIV-1 RNA <200 copies per milliliter) with a CD4+ count of more than 100 cells per microliter in the time of enrollment. Patients who can prevent pregnancy from the initiation of DAA therapy to 24 weeks after the end of DAA treatment (total 36 weeks).
Key exclusion criteria	Patients with non-compensated cirrhosis Patients with severe renal impairment (eGFR<30ml/minute/1.73m2) Patients with HBs antigen positive Patients who have active opportunistic infection Other drugs are adequate for the patients
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Hiroyuki Middle name Last name Gatanaga
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL	03-5273-5193
Email	higatana@acc.ncgm.go.jp

Public contact
1st name of contact person	1st name Haruka Middle name Last name Uemura
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	huemura@acc.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
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	National Center for Global Health and Medicine Ethical Committee
Address	1-21-1 Toyama, Shinjuku, Tokyo, Japan
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.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

Other administrative information
Date of disclosure of the study information	2017 Year 05 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	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2016 Year 02 Month 16 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	2017 Year 05 Month 17 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031265