A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects

GlaxoSmithKline41 sites in 1 country400 target enrollmentFebruary 2001

ConditionsHIV Infections

DrugsAbacavir sulfate, Lamivudine and Zidovudine Efavirenz

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: HIV Infections
Sponsor: GlaxoSmithKline
Enrollment: 400
Locations: 41
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Detailed Description

Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone. An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.

Registry

clinicaltrials.gov

Start Date

February 2001

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All