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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Dideoxynucleosides; Fosamprenavir; Lamivudine; Nelfinavir; Ritonavir

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.