A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

Phase 4 Completed GlaxoSmithKline

RandomizedParallel-groupTreatment

Summary

The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

Timeline

Start: 2004-04-26
Primary completion: 2006-03-01
Completion: 2006-03-01

Outcome

Met primary endpoint

paper Non-inferiority of ABC/3TC/ZDV to ATV+3TC/ZDV was established with 62% vs. 59% of subjects achieving a VL < 50 c/mL at week 48 PMID 19358725 ↗

Publications

Kumar PN, Salvato P, LaMarca A, DeJesus E, Patel P, McClernon D, Florance A, Shaefer MS. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009 Apr 9;6:3. doi: 10.1186/1742-6405-6-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	300 mg	—
Subject	Atazanavir	Other / unclassified	400 mg	—
Subject	Lamivudine	Other / unclassified	150 mg	—
Subject	Zidovudine	Small molecule	300 mg	—