A Study of Two Anti-HIV Drug Combinations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|