UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000243 |
|---|---|
| Receipt number | 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 16:47:57 |
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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
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
mihonda@imcj.acc.go.jp
Sponsor or person
Institute
QD Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000306
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