A Study of Two Anti-HIV Drug Combinations

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00002203
Study type	Interventional
Source	NIH AIDS Clinical Trials Information Service
Contact
Status	Completed
Phase	N/A

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