UMIN-CTR Clinical Trial

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 na&iuml;ve, -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
Email

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
Email

Sponsor
Institute	International Medical Center of Japan
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001019