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

Arm | Intervention/treatment |
---|---|
Experimental: atazanavir arm
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
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Drug: atazanavir arm
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
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Active Comparator: efavirenz arm
Patients are treated with efavirenz 300mg along with Epzicom.
|
Drug: efavirenz
Patients are treated with efavirenz 300mg along with Epzicom.
|
- Antiretroviral effect at the 48th week [ Time Frame: 48 weeks ]
- 1. Evaluation of immunological effect and safety in 48 weeks. [ Time Frame: 48 weeks ]
- 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks. [ Time Frame: 96 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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.

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
Japan | |
International Medical Center of Japan | |
Shinjuku, Tokyo, Japan, 162-8655 |
Study Chair: | Shinichi Oka, M.D., phD. | International Medical Center of Japan |
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 |