HIV Infection Clinical Trial
Official title:
See Detailed Description
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.
Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B*5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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