Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be
administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that
both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to
demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing
fAPV/r, in ARV-naïve patients over a 96-week period.
This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV
therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3.
Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd)
and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston