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CompletedNCT00280969Updated Mar 30, 2015

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

A Phase 3 interventional study of atazanavir arm and efavirenz in HIV Infection, sponsored by International Medical Center of Japan. Completed at 1 site in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-30.

Sponsored by International Medical Center of Japan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
20 Years and older
Sex
Male
01

Study 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)

Read the 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.

02

Conditions studied

  • HIV Infection

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Keywords

  • HIV infection
  • treatment
  • efavirenz
  • atazanavir
  • ritonavir
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 71 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

International Medical Center of Japan is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    atazanavir arm

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

    Drug: atazanavir arm

  • Active comparator
    efavirenz arm

    Patients are treated with efavirenz 300mg along with Epzicom.

    Drug: efavirenz

Interventions

  • Drugatazanavir arm

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

  • Drugefavirenz

    Patients are treated with efavirenz 300mg along with Epzicom.

06

What researchers measure

Primary outcomes

  1. Antiretroviral effect at the 48th week

    Time frame: 48 weeks

Secondary outcomes

  1. 1. Evaluation of immunological effect and safety in 48 weeks.

    Time frame: 48 weeks

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

    Time frame: 96 weeks

07

Study locations

1 site
  • International Medical Center of Japan
    Shinjuku, Tokyo 162-8655, Japan
08

References and documents

Publications

  • 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. PubMed 21467701 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00280969
Lead sponsor
International Medical Center of Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
Responsible party
Shinichi Oka, M.D. (Director general, AIDS Clinical Center, International Medical Center of Japan) — Principal investigator
First posted
Jan 24, 2006
Start date
Sep 2005
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Mar 30, 2015

Study contacts

Shinichi Oka, M.D., phD.
study chair · International Medical Center of Japan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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