Comparing the Effectiveness Between Ritonavir Boosted Ata... | NCT00280969

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

NCT00280969

Sponsor

International Medical Center of Japan

Status

Completed

Last Update Posted

Mar 30, 2015Estimated

Enrollment

71Actual

Phase

Phase 3

Conditions

HIV Infection

Interventions

atazanavir arm
efavirenz

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jan 22, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2015

Last Update Posted Date

Mar 30, 2015Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atazanavir arm	Experimental	Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.	Drug: atazanavir arm
efavirenz arm	Active Comparator	Patients are treated with efavirenz 300mg along with Epzicom.	Drug: efavirenz

Interventions

Name	Type	Description	Arm Group Labels	Other Names
atazanavir arm	Drug	Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.	atazanavir arm

Measure	Description	Time Frame
Antiretroviral effect at the 48th week		48 weeks

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Shinichi Oka, M.D., phD.	International Medical Center of Japan	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
International Medical Center of Japan		Shinjuku	Tokyo	162-8655	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21467701	Result	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral