Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
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)
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
HIV Infection
Intervention
atazanavir arm, efavirenz
Location
International Medical Center of Japan
Shinjuku
Tokyo
Japan
162-8655
Status
Active, not recruiting
Source
International Medical Center of Japan
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00280969
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Eye Infections, Fungal
Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.
Mycobacterium Avium-intracellulare Infection
A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.
Pelvic Infection
Infection involving the tissues or organs in the PELVIS.
Zygomycosis
Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.
Cross Infection
Any infection which a patient contracts in a health-care institution.
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