UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017059 |
|---|---|
| Receipt number | R000019781 |
| Scientific Title | Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2023/10/31 10:02:25 |
* 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
Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Acronym
Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Scientific Title
Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Scientific Title:Acronym
Analysis of HCV DAA resistance mutations in HIV and HTLV-1 superinfection cases
Region
| Japan |
Condition
Condition
Patients HCV RNA is positive, and the HIV antibody or HTLV-1 antibody-positive,
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In superinfection cases of HIV or HTLV-1 and HCV, to analyze the HCV DAA resistant mutation frequency, primarily to clarify the temporal change of HCV DAA resistance mutations after treatment intervention in HIV infection.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-The presence or absence of HCV DAA-resistant amino acid mutations
-The presence or absence of HCV NS3 area DAA-resistant amino acid mutations
-The presence or absence of HCV NS5A area DAA-resistant amino acid mutations
-The presence or absence of HCV NS5B area DAA-resistant amino acid mutations
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients was admitted to our hospital from January 2008 to December 2014
-Patients HCV RNA is positive, and the HIV antibody or HTLV-1 antibody-positive
-Cases save serum amount (500Micro milliliter) is stored
Key exclusion criteria
-Patients already that against HCV, interventions such as IFN treatment has been carried out
-HCV RNA is a viral load low value is also positive, nucleotide sequence analysis is difficult cases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Kazuhiko |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
8508501
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7481
kazuhiko@net.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Miuma |
| Middle name | |
| Last name | Satoshi |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7841
Homepage URL
miuma1002@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
| 2015 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
28
Results
HCV RNA was extracted using the remaining serum, and DAA drug resistance mutations were analyzed using direct sequencing.
DAA drug resistance mutations were observed in 2 out of 6 HIV co-infected cases and in 5 out of 22 HTLV-1 co-infected cases, but the frequency of these mutations was similar to that in HCV monoinfected cases.
Results date posted
| 2023 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
6 cases of HCV/HIV co-infection and 22 cases of HCV/HTLV-1 co-infection in our hospital
Participant flow
6 cases of HCV/HIV co-infection and 22 cases of HCV/HTLV-1 co-infection in our hospital
Adverse events
none
Outcome measures
HCV RNA was extracted using the remaining serum, and DAA drug resistance mutations were analyzed using direct sequencing.
DAA drug resistance mutations were observed in 2 out of 6 HIV co-infected cases and in 5 out of 22 HTLV-1 co-infected cases, but the frequency of these mutations was similar to that in HCV monoinfected cases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory observational clinical study
Management information
Registered date
| 2015 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
