NCT00280969

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

January 22, 2006

Last Update Submit

March 27, 2015

Conditions

HIV Infection

Keywords

HIV infectiontreatmentefavirenzatazanavirritonavir

Outcome Measures

Primary Outcomes (1)

  • Antiretroviral effect at the 48th week

    48 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

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

atazanavir armDRUG

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

atazanavir arm
efavirenzDRUG

Patients are treated with efavirenz 300mg along with Epzicom.

efavirenz arm

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Medical Center of Japan

Shinjuku, Tokyo, 162-8655, Japan

Location

Related Publications (1)

  • 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.

    PMID: 21467701RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Shinichi Oka, M.D., phD.

    International Medical Center of Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director general, AIDS Clinical Center

Study Record Dates

First Submitted

January 22, 2006

First Posted

January 24, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

JP(1)