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Original ArticleOpen Access
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
Chetchotisakd P 
,
Mootsikapun P ,
Anunnatsiri S ,
Boonyaprawit P ,
Wankun J
,
Mootsikapun P ,
Anunnatsiri S ,
Boonyaprawit P ,
Wankun J PIROON MOOTSIKAPUN, M.D.*,
PARICHART BOONYAPRAWIT,B.Sc.*,
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/mm
3
*
The mean log
10
HIV-1 RNA was 5.27 copies/mL. Using an on-treat-
ment analysis, the reduction in plasma log
10
HIV-1 RNA of BID and TID groups was not statisti-
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-naเธ—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.
Key word : Saquinavir-Soft Gel Capsule, BID Dose, Highly Active Antiretroviral Therapy,
Advanced AIDS
PARICHART BOONYAPRAWIT,B.Sc.*,
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/mm
3
*
The mean log
10
HIV-1 RNA was 5.27 copies/mL. Using an on-treat-
ment analysis, the reduction in plasma log
10
HIV-1 RNA of BID and TID groups was not statisti-
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-naเธ—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.
Key word : Saquinavir-Soft Gel Capsule, BID Dose, Highly Active Antiretroviral Therapy,
Advanced AIDS
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