UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study to evaluate efficacy and safety of sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV and HCV co-infected hemophiliacs
Acronym	Sofosbuvir and daclatasvir for HCV genotype 3 in HIV co-infected hemophiliacs
Scientific Title	A pilot study to evaluate efficacy and safety of sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV and HCV co-infected hemophiliacs
Scientific Title:Acronym	Sofosbuvir and daclatasvir for HCV genotype 3 in HIV co-infected hemophiliacs
Region	Japan

Condition
Condition	HIV infection, AIDS, Chronic hepatitis C infection
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The main objective of this trial is to evaluate the efficacy and safety of a treatment with sofosbuvir and daclatasvir for HCV genotype 3 infection in HIV/HCV co-infected hemophiliacs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome is a sustained virologic response at week 12 after the end of therapy.
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	Patients receive sofosbuvir 400mg plus daclatasvir 60mg once daily for 12 weeks. In patients receiving antiretroviral therapy with protease inhibitor plus booster, dose of daclatasvir is adjusted to 30mg. In patients receiving antiretroviral therapy with non-nucleic acid reverse transcriptase inhibitor except for rilpivirine, dose of daclatasvir is adjusted to 90mg.
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	Not applicable
Gender	Male
Key inclusion criteria	Hemophiliacs infected with HIV and HCV genotype 3 Patients did not complete treatment or treatment failure with IFN An HCV RNA positive at screening HIV RNA less than 50 copies per mL for at least 8 weeks prior to screening CD4 cell count must be more than 200 cells per micro liter for at least 8 weeks prior to screening Men must agree to follow contraception for the duration of treatment with study drugs and 14 weeks post treatment completion Patients agree to take study drugs that are not approved to use as a combination even though both drugs are approved for each in HCV treatment
Key exclusion criteria	Decompensated liver disease Severe renal impairment eGFR less than 30mL per min per 1.73m2 HBsAg seropositive Presence of active AIDS defining opportunistic infections to treat Use of prohibited treatments rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, dexamethasone, St. John's wort containing food Any other medical, psychiatric or social reason wich, in the opinion of the investigator would make the subject inappropriate for the study
Target sample size	4

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Oka
Organization	National center for global health and medicine
Division name	AIDS clinical center
Zip code	1628655
Address	1-21-1, Toyama, Shinjuku, Tokyou, Japna
TEL	03-3202-7181
Email	oka@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	1628655
Address	1-21-1, Toyama, Shinjuku, Tokyou, Japna
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, Tokyou, Japna
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	National center for global health and medicine

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	3
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	Completed
Date of protocol fixation	2015 Year 08 Month 27 Day
Date of IRB	2015 Year 10 Month 20 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 06 Day
Last modified on	2022 Year 11 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022569