Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
This study has been completed.
Sponsor:
International Medical Center of Japan
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Shinichi Oka, M.D., International Medical Center of Japan
ClinicalTrials.gov Identifier:
NCT00280969
First received: January 22, 2006
Last updated: March 27, 2015
Last verified: March 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: atazanavir arm Drug: efavirenz |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz |
Resource links provided by NLM:
Further study details as provided by International Medical Center of Japan:
Primary Outcome Measures:
- Antiretroviral effect at the 48th week [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 71 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Genders 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280969
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
| 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 |
| Study First Received: | January 22, 2006 |
| Last Updated: | March 27, 2015 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 27, 2016