comparison of gw433908/ritonavir to nelfinavir when used with abacavir and lamivudine in patients that have not taken antiretroviral drugs

Conditions: HIV Infections

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.

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.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 13 years old (consent of parent or guardian needed if under 18). * agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children. * have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (nrti) and have never received any nonnucleoside reverse transcriptase inhibitor (nnrti) or protease inhibitor (pi). mothers who have previously received 1 dose of the nnrti nevirapine during pregnancy for prevention of mother-to-child hiv transmission are permitted to enter the study. * have a viral load (amount of hiv in the blood) of 1,000 copies/ml or more. exclusion criteria patients will not be eligible for this study if they: * abuse drugs or alcohol in a way that would interfere with study requirements. patients who are stable on methadone will be considered for the study. * have an active/acute cdc category c event. * are unable to absorb or take medicines by mouth. * are pregnant or breast-feeding. * have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient. * have had pancreatitis or hepatitis within the last 6 months. * have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study. * have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-hiv activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken. * have received an hiv vaccine within 3 months before the study drug will be taken. * have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study. * have received experimental treatments. * have allergies which might interfere with the study, in the opinion of the doctor.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors ritonavir lamivudine nelfinavir reverse transcriptase inhibitors anti-hiv agents abacavir