NCT01102972

A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.

Detailed description

A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV for 48 weeks in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Reyataz + Norvir + Truvada	atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg
DRUG	Reyataz + Epzicom	atazanavir 400mg + abacavir 600mg/lamivudine 300mg

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-04-13
• Last updated: 2013-11-19
• Results posted: 2012-12-31

Locations

46 sites across 2 countries: United States, Puerto Rico