Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection|
|Study Start Date:||September 1999|
Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.
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