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

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ClinicalTrials.gov Identifier: NCT00280969
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : March 30, 2015
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Shinichi Oka, M.D., International Medical Center of Japan

Study Description
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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)

Condition or disease Intervention/treatment Phase
HIV Infection Drug: atazanavir arm Drug: efavirenz Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz
Study Start Date : September 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: atazanavir arm
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
 Drug: atazanavir arm
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
Active Comparator: efavirenz arm
Patients are treated with efavirenz 300mg along with Epzicom.
 Drug: efavirenz
Patients are treated with efavirenz 300mg along with Epzicom.


Outcome Measures
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Primary Outcome Measures :
  1. Antiretroviral effect at the 48th week [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280969


Locations
Japan
International Medical Center of Japan
Shinjuku, Tokyo, Japan, 162-8655
Sponsors and Collaborators
International Medical Center of Japan
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Shinichi Oka, M.D., phD. International Medical Center of Japan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Shinichi Oka, M.D., Director general, AIDS Clinical Center, International Medical Center of Japan
ClinicalTrials.gov Identifier: NCT00280969     History of Changes
Other Study ID Numbers: QD001
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Shinichi Oka, M.D., International Medical Center of Japan:
HIV infection
treatment
efavirenz
atazanavir
ritonavir

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers