HIV infectioin
Conditions
Interventions
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
Sponsors
QD Study Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)CD4 within 6 weeks prior to randomization is between 100 and 350 cells/mm3. 2)Body weight more than 40 kg. 3)Enable to obtain the written informed consent.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antiretroviral effect at the 48th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks. | — |
Countries
Japan
Contacts
Public ContactMiwako Honda, M.D.
International Medical Center of Japan AIDS Clinical Center
Outcome results
None listed