UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027371
Receipt No. R000031265
Scientific Title Research for evaluation of efficacy and safety of DAA therapy in HIV/HCV co-infected patients disorders
Date of disclosure of the study information 2017/05/23
Last modified on 2019/05/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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/ctr_e/ctr_view.cgi?recptno=R000031265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.