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

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Drug: atazanavir arm; Drug: efavirenz

• Registration Number: NCT00280969
• Lead Sponsor: International Medical Center of Japan

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)

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-22
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-24
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atazanavir arm	atazanavir arm	Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
efavirenz arm	efavirenz	Patients are treated with efavirenz 300mg along with Epzicom.

Primary Outcome Measures

Name	Time	Method
Antiretroviral effect at the 48th week	48 weeks

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of immunological effect and safety in 48 weeks.	48 weeks
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.	96 weeks

Trial Locations

Locations (1)

International Medical Center of Japan; 🇯🇵 Shinjuku, Tokyo, Japan