UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027371 |
|---|---|
| Receipt number | 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 12:04:02 |
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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
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
huemura@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031265
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| Registered date | File name |
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