UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008746 |
|---|---|
| Receipt number | R000010270 |
| Scientific Title | Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response: a pilot study |
| Date of disclosure of the study information | 2012/08/21 |
| Last modified on | 2017/12/23 09:37:53 |
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Basic information
Public title
Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response: a pilot study
Acronym
Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response
Scientific Title
Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response: a pilot study
Scientific Title:Acronym
Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response
Region
| Japan |
Condition
Condition
HIV-1 infection
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the efficacy and the safety of maraviroc, a C-C chemokine receptor type 5 (CCR5) antagonist, as an add-on treatment to optimized background anti-retroviral therapy in treatment-experienced patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of CD4+ T cell count from baseline to 24, 48 and 96 weeks.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Maraviroc (150-300mg twice daily), as an add-on treatment to optimized background anti-retroviral therapy in treatment-experienced patients.
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 and Female
Key inclusion criteria
1. Patients with HIV-1 infection
2. Age > 20 years old
3. Patients who have received > 3 classes of anti-HIV drugs for more than 48 weeks
4. Patients who were not changed anti-retroviral therapy regimen for more than 24 weeks
5. Patients with a CD4+ T cell count < 350 cells/microL
6. Patients who were not experienced a CCR5 antagonist treatment
7. No pregnat and lactating woman
8. Completed the written informed consent
Key exclusion criteria
1. Patients who could be changed anti-retroviral therapy regimen during the research
2. Patients with hypersensivity to CCR5 antagonist
3. Patients with severe underlyng heart diseases
4. Patients with liver cirrhosis or liver dysfunction: AST or ALT > 3 upper limit of normality
5. Patients with renal dysfunction: eGFR<60mL/min/1.73m2
6. Patients with neutrophil< 1,000/microL, hemoglobin<10g/dL, or platelet< 100,000/microL
7. Patients with severe infectious diseases such as mycobacterium infection, deep fungal infection, cytomegalovirus infection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hayashi |
Organization
Kyushu-University Hospital
Division name
Department of General internal medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5909
hayashij@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Murata |
Organization
Kyushu-University Hospital
Division name
Department of General internal medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
mmurata@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu-University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu-University Hospital
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
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010270
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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