NCT00009061

Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 624 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Ritonavir
DRUG	Abacavir sulfate
DRUG	Nelfinavir mesylate
DRUG	Lamivudine
DRUG	GW433908

Timeline

• Start date: 2000-11-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

37 sites across 1 country: United States