NCT00004852

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Efavirenz
DRUG	Lamivudine
DRUG	Zidovudine

Timeline

• Start date: 1999-09-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

66 sites across 5 countries: United States, Argentina, Brazil, Canada, Puerto Rico