A Study of Two Anti-HIV Drug Combinations
|ClinicalTrials.gov Identifier: NCT00002203|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Lamivudine/Zidovudine Drug: Lamivudine Drug: Zidovudine||Not Applicable|
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 (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|