Conditions: Infection, Human Immunodeficiency Virus
Keywords: HIV-1 HIV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 297
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Subjects will change to ATV 400mg administered as two 200mg capsules orally, once daily and to the fixed-dose combination tablet of ABC 600mg/3TC 300mg (EPZICOM) administered as one tablet orally, once daily for 48 weeks. The subject's pre-study RTV will be discontinued. arm 2: Subjects will continue their pre-study therapy, un-modified, of ATV 300mg administered as one capsule orally, once daily plus RTV 100mg administered orally, once daily plus fixed dose combination tablet tenofovir 300mg/emtricitabine 200mg administered as one tablet orally, once daily for 48 weeks.

Interventions: intervention 1: Reyataz + Norvir + Truvada intervention 2: Reyataz + Epzicom
Intervention descriptions: intervention 1: atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg intervention 2: atazanavir 400mg + abacavir 600mg/lamivudine 300mg

Protocol document: