Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
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ClinicalTrials.gov Identifier: NCT00009061
Recruitment Status : Unknown
Verified March 2002 by NIH AIDS Clinical Trials Information Service. 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.
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.
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 :
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Ages Eligible for Study:
13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.