Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments ritonavir, abacavir sulfate, nelfinavir mesylate, lamivudine, gw433908
Phase phase 3
Sponsor Glaxo Wellcome
Start date November 2000
Trial size 624 participants
Trial identifier NCT00009061, 316B, APV30002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 13 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.