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.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Pacific Oaks Med Ctr
Beverly Hills, California, United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
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Infectious Diseases Physicians Inc
Annandale, Virginia, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States
San Juan AIDS Program
Santurce, Puerto Rico