A randomized, open-label, comparative trial of BID and TID dosing of saquinavir enhanced oral formulation as part of a triple therapy for advanced AIDS patients.
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-naïve, advanced AIDS patients.


METHODS
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 log10 HIV-1 RNA was 5.27 copies/mL. Using an on-treatment analysis, the reduction in plasma log10HIV-1 RNA of BID and TID groups was not statistically 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).


CONCLUSIONS
The preliminary data suggests that in antiretroviral-naïve, 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.
Chetchotisakd
Ploenchan
P
Department of Medicine, Faculty of Medicine, Khon Kaen University, Thailand.
Anunnatsiri
Siriluck
S
Wankun
Jaturaporn
J
Mootsikapun
Piroon
P
Boonyaprawit
Parichart
P
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D012367:RNA, Viral / Q000032:analysis; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D019258:Saquinavir / Q000008:administration & dosage*; D015215:Zidovudine / Q000008:administration & dosage*
D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019258:Saquinavir