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Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
atazanavir arm
efavirenz
Sponsored by
International Medical Center of Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, treatment, efavirenz, atazanavir, ritonavir

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: serological diagnosis of HIV infection male aged over 20 years old CD4 at enrollment between 100 to 300 body weight over 40kg enable to obtain the written informed consent Exclusion Criteria: Patients who are considered unable to complete 48 weeks of study by their physician. Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems. Patients who have the history of hypersensitivity with lamivudine. Hepatitis B carrier. Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils 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. Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study . Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception. Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition. Patients with AIDS defining illness. Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study. Patients with acute retroviral syndrome. Patients with psychiatric disorder. Patients whose physician consider the study enrollment inappropriate.

Sites / Locations

  • International Medical Center of Japan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

atazanavir arm

efavirenz arm

Arm Description

Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.

Patients are treated with efavirenz 300mg along with Epzicom.

Outcomes

Primary Outcome Measures

Antiretroviral effect at the 48th week

Secondary Outcome Measures

1. Evaluation of immunological effect and safety in 48 weeks.
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Full Information

First Posted
January 22, 2006
Last Updated
March 27, 2015
Sponsor
International Medical Center of Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00280969
Brief Title
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
Official Title
Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Medical Center of Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens 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 efavirenz)
Detailed Description
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens 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 efavirenz) The primary endpoint is antiretroviral effect at the 48th week. The secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV infection, treatment, efavirenz, atazanavir, ritonavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atazanavir arm
Arm Type
Experimental
Arm Description
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
Arm Title
efavirenz arm
Arm Type
Active Comparator
Arm Description
Patients are treated with efavirenz 300mg along with Epzicom.
Intervention Type
Drug
Intervention Name(s)
atazanavir arm
Intervention Description
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
Intervention Type
Drug
Intervention Name(s)
efavirenz
Intervention Description
Patients are treated with efavirenz 300mg along with Epzicom.
Primary Outcome Measure Information:
Title
Antiretroviral effect at the 48th week
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
1. Evaluation of immunological effect and safety in 48 weeks.
Time Frame
48 weeks
Title
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
Time Frame
96 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: serological diagnosis of HIV infection male aged over 20 years old CD4 at enrollment between 100 to 300 body weight over 40kg enable to obtain the written informed consent Exclusion Criteria: Patients who are considered unable to complete 48 weeks of study by their physician. Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems. Patients who have the history of hypersensitivity with lamivudine. Hepatitis B carrier. Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils 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. Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study . Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception. Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition. Patients with AIDS defining illness. Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study. Patients with acute retroviral syndrome. Patients with psychiatric disorder. Patients whose physician consider the study enrollment inappropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Oka, M.D., phD.
Organizational Affiliation
International Medical Center of Japan
Official's Role
Study Chair
Facility Information:
Facility Name
International Medical Center of Japan
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21467701
Citation
Honda M, Ishisaka M, Ishizuka N, Kimura S, Oka S; Japanese Anti-HIV-1 QD Therapy Study Group. Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Intern Med. 2011;50(7):699-705. doi: 10.2169/internalmedicine.50.4572. Epub 2011 Apr 1.
Results Reference
result

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Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment

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