Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
Recruitment status was Active, not recruiting
The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Drug: Abacavir sulfate
Drug: Nelfinavir mesylate
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects|
|Study Start Date:||November 2000|
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
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