A Study of Two Anti-HIV Drug Combinations
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002203
|United States, California|
|Pacific Oaks Med Ctr|
|Beverly Hills, California, United States, 90211|
|Tower Infectious Diseases / Med Associates Inc|
|Los Angeles, California, United States, 90048|
|United States, North Carolina|
|Univ of North Carolina Hosps|
|Chapel Hill, North Carolina, United States, 27599|
|Carolinas Med Ctr|
|Charlotte, North Carolina, United States, 28232|
|United States, Virginia|
|Infectious Diseases Physicians Inc|
|Annandale, Virginia, United States, 22003|
|United States, Wisconsin|
|Univ of Wisconsin School of Medicine|
|Madison, Wisconsin, United States, 53792|
|San Juan AIDS Program|
|Santurce, Puerto Rico, 00907|