Overview

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.
Phase:
Phase 3
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Abacavir
Atazanavir Sulfate
Dideoxynucleosides
Lamivudine
Ritonavir