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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by International Medical Center of Japan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
International Medical Center of Japan
ClinicalTrials.gov Identifier:
NCT00280969
First received: January 22, 2006
Last updated: June 22, 2008
Last verified: June 2008

January 22, 2006
June 22, 2008
September 2005
July 2008   (final data collection date for primary outcome measure)
Antiretroviral effect at the 48th week [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Antiretroviral effect at the 48th week
Complete list of historical versions of study NCT00280969 on ClinicalTrials.gov Archive Site
  • 1. Evaluation of immunological effect and safety in 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • 1. Evaluation of immunological effect and safety in 48 weeks.
  • 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
Not Provided
Not Provided
 
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
Open-Label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz

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)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: atazanavir arm
    Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
  • Drug: efavirenz
    Patients are treated with efavirenz 300mg along with Epzicom.
  • Experimental: atazanavir arm
    Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
    Intervention: Drug: atazanavir arm
  • Active Comparator: efavirenz arm
    Patients are treated with efavirenz 300mg along with Epzicom.
    Intervention: Drug: efavirenz
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. Epub 2011 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
71
September 2008
July 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00280969
QD001
Yes
Shinichi Oka, Director general, AIDS Clinical Center, International Medical Center of Japan
International Medical Center of Japan
Ministry of Health, Labour and Welfare, Japan
Study Chair: Shinichi Oka, M.D., phD. International Medical Center of Japan
International Medical Center of Japan
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP