A Randomized, Open-Label, Comparative Trial of BID and TID Dosing of Saquinavir Enhanced Oral Formu lation as Part of a Triple Therapy for Advanced AIDS Patients
PLOENCHAN CHETCHOTISAKD, M.D.*, PIROON MOOTSIKAPUN, M.D.*, SIRILUCK ANUNNATSIRI, M.D.*, PARICHART BOONYAPRAWIT,B.Sc.*, JATURAPORN WANKUN,B.Sc.*
Affiliation : * Infectious Disease Unit, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.
Objective : To compare the efficacy and safety of 1,400 mg BID and 1,200 mg TID of saquinavir soft gel given with zidovudine and lamivudine in antiretroviral-na"ive, advanced AIDS patients.
Method : A randomized, open-label study conducted at a university hospital.
Results : Forty cases were enrolled in the study, 20 cases in each group. The mean CD4 cell count was 29 cells/mm3 The mean log HIV-1 RNA was 5.27 copies/mL. Using an on-treat * 10 ment analysis, the reduction in plasma log HIV-1 RNA of BID and TID groups was not statisti 10 cally significant at -2.44 vs -2.60 copies/mL (-0.16, 95% CI -0.63 to 0.30; p= 0.48). The mean increase in CD4 cell counts was not statistically significant at + 144 and + 159 cells/mm3 11, 95% CI ( -75 to 97; p=0.79).
Conclusion : The preliminary data suggests that in antiretroviral-na·ive, advanced AIDS patients, 1,400 mg BID of saquinavir soft gel given with two nucleoside analogues might be as effective as the standard 1,200 mg TID.
Keywords : Saquinavir-Soft Gel Capsule, BID Dose, Highly Active Antiretroviral Therapy, Advanced AIDS
