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Recruitment status Completed
Unique ID issued by UMIN UMIN000008746
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu-University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010270


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