NCT00002203

A Study of Two Anti-HIV Drug Combinations

A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients

• Status: Completed
• Phase: N/A
• 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 compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.

Detailed description

It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor. Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lamivudine/Zidovudine
DRUG	Lamivudine
DRUG	Zidovudine

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

7 sites across 2 countries: United States, Puerto Rico