Open-label randomized multicenter study of once daily antiretroviral treatment regimen comparing ritonavir boosted atazanavir to efavirenz

UMIN ID: C000000243

Registered date:21/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: HIV infectioin
• Date of first enrollment: 2005/09/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Epzicom(lamivudine 300mg/abacavir 600mg)1tablet plus Stocrin(efavirenz 200mg) 3 capsles once daily for 48 weeks
Epzicom(lamivudine 300mg/abacavir 600mg)1tablet plus Stocrin(efavirenz 200mg) 3 capsles once daily for 48 weeks

Outcome(s)

• Primary Outcome: Antiretroviral effect at the 48th week
• Secondary Outcome: 1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1)Patients who are considered unable to complete 48 weeks of study by their physician. 2)Patients who have gastrointestinal symptom which may interefare the absorption of antiretrovirals, or have swallowing problems. 3)Patients who have the history of hypersensitivity with lamivudine. 4)Hepatitis B carrier. 5)Blood test results within 4 weeks prior to the randomizaiton; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutorphils 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. 6)Patients who have had radiatioin or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study . 7)Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteriod is the exception. 8)Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition. 9)Patients with AIDS defining illness. 10)Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study. 11)Patients with acute retroviral syndrome. 12)Patients with psychiatric disorder. 13)Patients whose phycian consider the study enrollment inappropreate.

Related Information

• Primary Sponsor: QD Study Group
• Source(s) of Monetary Support: Japan Foundation for the Promotion of International Medical Research Cooporation