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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000261
Receipt No. R000000325
Scientific Title Pilot study to evaluate the anti-viral effect of Simvastatin for patiets with HIV-1.
Date of disclosure of the study information 2005/12/01
Last modified on 2005/10/07

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Basic information
Public title Pilot study to evaluate the anti-viral effect of Simvastatin for patiets with HIV-1.
Acronym Pilot study to evaluate the anti-viral effect of Simvastatin for patiets with HIV-1.
Scientific Title Pilot study to evaluate the anti-viral effect of Simvastatin for patiets with HIV-1.
Scientific Title:Acronym Pilot study to evaluate the anti-viral effect of Simvastatin for patiets with HIV-1.
Region
Japan

Condition
Condition HIV-1 infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-viral effect of simvastatin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma HIV RNA.
Key secondary outcomes 1. Absolute CD4 cell counts.
2. Plasma total cholesterollevels,
triglyceride levels and other biochemical tests.

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 Oral administration of simvastatin (10mg/day) for 8 weeks.
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. Documentation of HIV-1 infection by Western Blot.
2. Absolute CD4+ cell counts have never been below 350 /microL.
3. No history of anti-HIV drug treatment.
4. Age >= 20 years and signed informed consent form.
Key exclusion criteria 1. HIV-RNA is not detectable.
2. Acute HIV infection.
3. Use of HMG-CoA reductase inhibitors (includings simvastatin) within 2 months prior to registration.
4. Immunodeficiency disorders (e.g. malignant diseases, chronic granulomatous disease, Wiskott-Aldrich syndrome).
5. Use of systemic corticosteroids, methotrexate and other immunosuppressants.
6. Autoimmune/imflammatory diseases.
7. Pregnat women or women of childbearing potential or brestfeeding
8. Addiction to alcohol or other drugs.
9. Hypothyroidism.
10. Inherited muscle disorders or family history of those disorders.
11. History of drug-induced muscle diseases.
12. Drug allergy to simvastatin or other HMG-CoA reductase inhibitors.
13. Sever liver disordors (Aspartate aminotransferase or Alanine aminotransrerase >= 100 IU/L or total bilirubin >= 2.0 mg/dL).
14. Sever renal disease (Creatinine >= 2.0 mg/dL).
15. Thrombocytopenia(Platelet counts <= 100,000/microL).
16. Total cholesterol <= 150mg/dL or trigryceride <= 50mg/dL.
17. Taking the following drugs: Azole antifungal agents (e.g. itraconazole, miconazole), HMG-CoA reductase inhibitors (excluding simvastatin), Fibric acid derivatives (e.g. bezafibrate), Warfarin, Nicotic acid, Cyclosporine, Macrolides (e.g. erythromycin, clarithromycin), HIV protease inhibitors (e.g. ritonavir)
18. Use of other investigational drugs within 2 months prior to this treatment.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Ota
Organization The University of Tokyo Hospital
Division name Department of Infectious Diseases
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Ota
Organization The University of Tokyo Hospital
Division name Department of Infectious Diseases
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute Department of Infectious Diseases, The University or Tokyo Hospital
Institute
Department

Funding Source
Organization Department of Infectious Diseases, The University of Tokyo 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

Other administrative information
Date of disclosure of the study information
2005 Year 12 Month 01 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
Date of protocol fixation
2005 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2007 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 10 Month 07 Day
Last modified on
2005 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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