UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000849 |
|---|---|
| Receipt number | R000001019 |
| Scientific Title | A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined with Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection |
| Date of disclosure of the study information | 2007/10/15 |
| Last modified on | 2022/04/13 10:24:17 |
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Basic information
Public title
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined with Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection
Acronym
ET Study
Scientific Title
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined with Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection
Scientific Title:Acronym
ET Study
Region
| Japan |
Condition
Condition
HIV
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A non-inferiority randomized control trial in treatment naive HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of retonavir boosted atazanavir as key drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
antiretroviral effect over 48 weeks
Key secondary outcomes
1)The immunological effects from baseline at the 48th and 144th week
2)Reasons of treatment failure by 144th week
3)Adverse events and their rate of incidence by 144th week
4)Serum concentration of tenofovir in selected patients
5)Serum concentration of atazanavir in selected patients
6)Renal complication in tenofovir arm
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are treated with Epzicom (lamivudine 300mg plus abacavir 600mg) and atazanavir 300mg boosted with ritonavir 100mg for 144 weeks.
Interventions/Control_2
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) and atazanavir 300mg boosted with ritonavir 100mg for 144 weeks.
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
-Clinical diagnosis of HIV infection,
-Antiretroviral initiation is recommended by current clinical guidelines,
-Treatment naïve,
-Age over 20 years old Japanese,
-Able to obtain written informed consent
Key exclusion criteria
-Current malabsorption condition,
-Prior use of lamivudine for hepatitis B treatment,
-Positive serology of Hepatitis B surface antigen,
-Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
1)alanine aminotransferaseis is more than 2.5 times higher of upper normal limit
2)estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
3)serum phosphate level is less than 2.0mg/dl
-Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
-Patients in pregnancy, breast feeding,
-Patients who are taking medicaitions contraindicated for combine use with study medicine
-Patients whose primary care physicians consider inadequate to be enrolled
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
International Medical Center of Japan
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama Shinjuku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
International Medical Center of Japan
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama Shinjuku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Homepage URL
Sponsor or person
Institute
International Medical Center of Japan
Institute
Department
Personal name
Funding Source
Organization
International Medical Center of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00544128
Org. issuing International ID_1
National Institute of Health, USA
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 10 | Month | 15 | 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
| 2007 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2007 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001019
