UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000243
Receipt No. R000000306
Scientific Title Open-label randomized multicenter study of once daily antiretroviral treatment regimen comparing ritonavir boosted atazanavir to efavirenz
Date of disclosure of the study information 2005/09/21
Last modified on 2011/11/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Open-label randomized multicenter study of once daily antiretroviral treatment regimen comparing ritonavir boosted atazanavir to efavirenz
Acronym QD Study
Scientific Title Open-label randomized multicenter study of once daily antiretroviral treatment regimen comparing ritonavir boosted atazanavir to efavirenz
Scientific Title:Acronym QD Study
Region
Japan

Condition
Condition HIV infectioin
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatement regemens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efevirenz)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Antiretroviral effect at the 48th week
Key secondary outcomes 1. Evaluation of immunological effect and safety in 48 weeks.
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epzicom(lamivudine 300mg/abacavir 600mg)1tablet plus Stocrin(efavirenz 200mg) 3 capsles once daily for 48 weeks
Interventions/Control_2 Epzicom(lamivudine 300mg/abacavir 600mg)1tablet plus Stocrin(efavirenz 200mg) 3 capsles once daily for 48 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
Key inclusion criteria 1)CD4 within 6 weeks prior to randomization is between 100 and 350 cells/mm3.
2)Body weight more than 40 kg.
3)Enable to obtain the written informed consent.
Key exclusion criteria 1)Patients who are considered unable to complete 48 weeks of study by their physician.
2)Patients who have gastrointestinal symptom which may interefare the absorption of antiretrovirals, or have swallowing problems.
3)Patients who have the history of hypersensitivity with lamivudine.
4)Hepatitis B carrier.
5)Blood test results within 4 weeks prior to the randomizaiton; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutorphils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.
6)Patients who have had radiatioin or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study .
7)Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteriod is the exception.
8)Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition.
9)Patients with AIDS defining illness.
10)Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study.
11)Patients with acute retroviral syndrome.
12)Patients with psychiatric disorder.
13)Patients whose phycian consider the study enrollment inappropreate.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Oka, M.D.
Organization International Medical Center of Japan
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo162-8655, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miwako Honda, M.D.
Organization International Medical Center of Japan
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email mihonda@imcj.acc.go.jp

Sponsor
Institute QD Study Group
Institute
Department

Funding Source
Organization Japan Foundation for the Promotion of International Medical Research Cooporation
Organization
Division
Category of Funding Organization Non profit foundation
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 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 09 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jstage.jst.go.jp/article/internalmedicine/50/7/50_699/_article/-char/ja/
Number of participants that the trial has enrolled
Results
 <Results> 
A total of 71 participants were enrolled. Virologic success rates in both arms were similar at week 48 [efavirenz arm 28/36 (77.8%); atazanavir arm 27/35 (77.1%)], but were decreased at week 96 to 55.6% in the efavirenz arm and 68.8% in the atazanavir arm (p=0.33). At the 96-week follow-up, 52.8% of the EFV arm and 34.3% of the ATV/r arm reached total cholesterol more than 220 mg/dL and required treatment. None of the patients developed cardiovascular complications in this study by week 96. 

<Conclusion> 
There was no significant difference in the efficacy of efavirenz and ritonavir-boosted atazanavir combined with lamivudine plus abacavir at 48 weeks. The evaluation of safety was extended to 96 weeks, which also showed no significant difference in both arms. 
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
2005 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 20 Day
Last modified on
2011 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000306

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.