NCT00002320

A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Detailed description

Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks. PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lamivudine
DRUG	Zidovudine

Timeline

• First posted: 2001-08-31
• Last updated: 2005-12-12

Locations

22 sites across 3 countries: United States, Canada, Puerto Rico