ABSTRACT: Objective: To assess the safety, tolerability and antiviral activity of the protease inhibitor ABT-378/ritonavir (ABT-378/r) 200/100 mg BID, 400/100 mg BID, and 400/200 mg BID with stavudine and lamivudine.
Methods: Two groups of antiretroviral-naive patients were randomly as-signed to a blinded ABT-378/r dose: Group I (200/100 mg or 400/100 mg BID); Group II (400/100 mg or 400/200 mg BID) and treated for 24 weeks.
Results: Median baseline HIV RNA and CD4 cell count for Group I were 5.0 log10 copies/mL and 424 cells/mm3, and for Group II, 4.8 log10 copies/mL and 313 cells/mm3, respectively. After 24 weeks, the median HIV RNA decrease from baseline was 2.4 log10 copies/mL, and 27/29 (93%) patients in Group I had HIV RNA
Conclusions: All ABT-378/r doses were demonstrated to have excellent tolerability and antiretroviral activity with >93% of antiretroviral-naive patients with HIV RNA.
