Antiretroviral therapy in Thai adults and children with HIV-1 infection - Chapter 2: Pharmacokinetic study of saquinavir hard gel caps/ritonavir in HIV-1-infected patients: 1600/100 mg once-daily compared with 2000/1

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(1)UvA-DARE (Digital Academic Repository). Antiretroviral therapy in Thai adults and children with HIV-1 infection Ananworanich, J. Publication date 2008. Link to publication Citation for published version (APA): Ananworanich, J. (2008). Antiretroviral therapy in Thai adults and children with HIV-1 infection.. General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.. UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl) Download date:21 Jun 2021.

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(127)

(128) <6 CF824308;H 0??40A43 C> 14 B;>F4A C70= C74 01B>A?C8>= >5

(129)

(130) <6 >=24308;H >A

(131) <6 >=24308;H 86DA4

(132) ><?0A8=6 C74 B0@D8=0E8A ?70A<02>:8=4C82 ?0A0<4C4AB >5

(133)

(134) <6 CF824308;H F8C7 C7>B4 >5

(135)

(136) <6 >=24308;H C74A4 F0B 0 ;0A64 8=2A40B4 8= <8= F74= 3>B43 0B

(137)

(138) <6 CF824308;H 338C8>=0;;H C74 <40= B0@D8=0E8A - 8=2A40B43 1H F74= 3>B43 0B

(139)

(140) <6 CF824308;H ,74 E0;D4B 5>A <40= B0@D8=0E8A <0G >5 1>C7 A468<4=B F4A4 B8<8;0A ,74 8=C4A?0C84=C E0A8018;8CH 5>A B0@D8=0E8A <8= F0B 8= 0 B8<8 ;0A A0=64 E4ABDB 4G?A4BB43 0B 2>45J284=C >5 E0A8 0C8>= ,74 B0@D8=0E8A <0G 0=3 - >5

(141)

(142) <6 CF824308;H 3>B4 F4A4 0BB>280C43 F8C7 0= 8=2A40B4 8= 8=C4A?0C84=C E0A8018;8CH ,74 C>C0; 308;H 3>B4 >5 A8C>=0E8A 8= C74

(143)

(144) CF824308;H 0A< 0A< F0B 3>D1;4 C74 3>B4 >5 C74 >=24308;H A468<4= B 4G?42C43 <40= <0G <8= 0=3 - 5>A A8C>=0E8A B7>F43 8=2A40B4B F74= 3>B43 0C

(145)

(146) <6 CF824308;H ,01;4B 0=3 ,7A44 ?0C84=CB >=

(147)

(148) <6 >=24308;H 703 0 B0@D8=0 E8A CA>D67 ;4E4; ;>F4A C70= C74 A42><<4=343 CA>D67 ;4E4; >5

(149) <6 $ >5 B0@D8=0E8A

(150) ;; C7A44 ;4E4;B 8=2A40B43 01>E4 C74 A42><<4=343 CA>D67 ;4E4; >= 30H . '0!200',+ ,74 ?70A<02>:8=4C82B >5 1>C7 B0@D8=0E8A A8C>=0E8A

(151)

(152) <6 CF824308;H 0=3 B0@D8=0E8A A8C>=0E8A

(153)

(154) <6 >=24308;H 8= !.

(155) 8=542C43 ?0C84=CB 70E4 144= 34B2A8143 145>A4

(156)

(157) != C78B BCD3H C74 ?70A<02>:8=4C82B >5 CF> 3>B4B B0@D8=0E8A A8C>=0E8A

(158) <6 >=24308;H 0=3

(159)

(160) <6 CF824308;H F4A4 2><?0A43 F8C7 C74 ?70A<02>:8=4C82B >5

(161)

(162) <6 >=24308;H +0@D8=0E8A A8C>=0E8A F74= 3>B43 0B

(163) <6 >=24308;H >A

(164)

(165) <6 CF824308;H B7>F43 8=2A40B43 - 0=3 <8= 2><?0A43 F8C7 F74= 3>B43 0B

(166)

(167) <6 >=24308;H '=;H C74 B0@D8=0E8A <0G 8=2A40B43 8= C74

(168) <6 >=24308;H 0A< 0A<

(169) F74A40B C74A4 F0B => 270=64 8= B0@D8=0E8A <0G 8= C74

(170)

(171) <6 CF824308;H 0A< 0A< 'E4A0;; ?70A<02>:8=4C82 ?0A0<4C4AB 8<?A>E43 F8C7 C74

(172) <6 >=24308;H 3>B4 F74A40B C74 <8= 8<?A>E43 <0A:43;H F8C7 C74

(173)

(174) <6 CF824308;H 3>B4 !=2A40B8=6 C74 3>B4 >5 B0@D8=0E8A 5A><

(175)

(176) <6 >=24 308;H C>

(177) <6 CF824308;H 60E4 0 78674A B0@D8=0E8A 4G?>BDA4 ,F> >1B4AE0C8>=B 20= 14 <034 5A>< C74B4 J=38=6B 8ABC C74 8=2A40B4 8= B0@D8=0E8A 4G?>BDA4 8B <>A4 C70= 3>B4 ?A>?>AC8>=0; C74A41H BD664BC8=6 =>=;8=40A :8=4C82B >5 B0@D8=0E8A F74= 2><18=43 F8C7 ;>F 3>B4B >5 A8C>=0E8A ,74 8=2A40B4 20= 14 4G?;08=43 0B C74 A4BD;C >5 >=6>8=6 ?A>24BB4B C74 2>=C8=D0C8>= >5 B0@D8=0E8A 01B>A?C8>= C74 8=7818C8>= >5 ( 4=IH<4B 8= C74 6DC 0=3 ;8E4A ;4038=6 C> 342A40B43 JABC?0BB <4C01>;8B< 0=3 ?4A 70?B 8=7818C8>= >5 (6;H2>?A>C48=

(178)

(179) +42>=3 C74 01B>A?C8>= >5 B0@D8=0E8A 8B =>C <0G8<0; F74= 3>B43 0B

(180) <6 >=24308;H ,78B >1B4AE0C8>= 8B 8= 2>=CA0BC C> 740;C7H E>;D=C44A 30C0 5>A B0@D8=0E8A A8C>=0E8A >B8=6 >5 B0@D8=0E8A A8C>=0E8A 0B

(181)

(182) <6 >=24308;H ;43 C> ;>F4A B0@D8=0E8A ?;0B<0 4G?>BDA4

(183) >F4E4A C74A4 F4A4 ;8<8C0C8>=B 8= C74 740;C7H E>;D=C44A BCD3H 0 A4;0C8E4;H B<0;; =D<14A >5 ?0C84=CB 0 ;02: >5 8=CA0?0C84=C 2><?0A8B>= 0=3 0 38554A4=C 384C 0AH 2><?>B8C8>= 5A>< C70C >5 C78B BCD3H != C74

(184)

(185) <6 CF824308;H 0A< 1>C7 C74 B0@D8=0E8A 0=3 A8C>=0E8A 308;H 3>B064B F4A4 78674A C70= F8C7 C74

(186)

(187) <6.

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(189)

(190) <6 '. A<

(191) 1

(192) <0G <6 $ <8= <6 $ - L <6M7 $ <0G 7 6

(193) 7 " :6 $ :6. 0H +). *,.

(194) <6 '. +).. *,.. +).. O O O O

(195) O

(196) O

(197) O .

(198) O O

(199) O

(200) O O

(201)

(202)

(203)

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(205) . O O O

(206) O O O

(207) O . 0H +). *,.

(208)

(209) <6 '. A< 1

(210) <0G <6 $ <8= <6 $ - L <6M7 $ <0G 7 6

(211) 7 " :6 $ :6. *,.

(212) O O

(213) O O

(214) O O

(215)

(216) O . 0H +). *,.

(217)

(218) <6 . +).. *,.. +).. *,.. O

(219) O

(220) O

(221) O

(222) O O O .

(223) O O

(224) O O O

(225)

(226) O

(227)

(228)

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(230) O O $ O

(231) O

(232) O

(233) O .

(234) O

(235) O O

(236) $ O

(237)

(238) O

(239)

(240) O

(241) O

(242) . <0G <0G8<D< >1B4AE43 2>=24=CA0C8>= <8= <8=8<D< >1B4AE43 2>=24=CA0C8>= - 0A40 D=34A C74 2DAE4 " E>;D<4 >5 38BCA81DC8>= $ 2;40A0=24 +). B0@D8=0E8A *,. A8C>=0E8A ' >=24308;H CF824308;H $ - L

(243) . <0G. C8<4 C> A4027 <0G 6

(244) C4A<8=0; 70;5;854. )# 70=64 8= ?70A<02>:8=4C82 ?0A0<4C4AB %* F8C7 ! +). *,.

(245)

(246) <6 '

(247) <6 '. +). <0G +). <8= +). - L . %*. !.

(248)

(249)

(250)

(251).

(252) L

(253)

(254) L

(255) L . *,. <0G *,. <8= *,. - L . %*. !.

(256)

(257)

(258)

(259)

(260) .

(261) L

(262) L

(263)

(264) L

(265) . %*. !.

(266)

(267)

(268) .

(269)

(270) L

(271)

(272) L

(273)

(274)

(275) L . +). *,.

(276)

(277) <6 '

(278)

(279) <6 . +). <0G +). <8= +). - L . %*. !.

(280) . L

(281) L

(282) L

(283) . *,. <0G *,. <8= *,. - L . %* 64><4CA82 <40= A0C8> ! 2>=J34=24 8=C4AE0; <0G <0G8<D< >1B4AE43 2>=24=CA0C8>= <8= <8=8<D< >1B4AE43 2>=24=CA0C8>= - 0A40 D=34A C74 2DAE4 <0G C8<4 C> A4027 <0G +). B0@D8=0E8A *,. A8C>=0E8A ' >=24308;H CF824308;H. >=24308;H 3>B8=6 B <867C 14 4G?42C43 C74 4G?>BDA4 >5 B0@D8 =0E8A F0B 78674A ,74 <0A:43 8=2A40B4 8= <8= 8B BCA8:8=6 <>BC ;8:4;H 1420DB4 >5 8=2A40B43 A8C>=0E8A 4G?>BDA4 F7827 4=70=24B C74 8=7818C8=6 45542C >5 ( 8= C74 6DC 0=3 C74 ;8E4A 608= C74 A>;4 >5 (6;H2>?A>C48= 20==>C 14 4G2;D343 ,74 ;02: >5 38554A 4=24 14CF44= C74 <0G E0;D4B >5 C74

(284)

(285) <6 >=24308;H 0=3 C74

(286)

(287) <6 CF824308;H 3>B8=6 BD664BCB C70C C74 01B>A? C8>= >5 B0@D8=0E8A 8B ;>F4A 5>A

(288)

(289) <6 CF824308;H 3>B8=6 AD6 ;4E4;B 8= C78B BCD3H F4A4 78674A C70= A4?>AC43 ;4E4;B 5>A 0D20B80= ?0C84=CB

(290) ,78B 20= 14 ?0AC;H 4G?;08=43 1H C74 7867. =D<14A >5 54<0;4B 8= C78B BCD3H

(291)

(292) A424=C BCD3H B7>F43 C70C 54<0;4 !.8=542C43 ?0C84=CB 703 0 78674A B0@D8=0E8A ;4E4; 2><?0A43 F8C7 <0;4 !.8=542C43 ?0C84=CB

(293) 'C74A ?>C4=C80; 502 C>AB C70C <867C 14 >5 8=KD4=24 0A4 C74 270A02C4A8BC82B >5 C74 ?0C84=CB BD27 0B 1>3H 2><?>B8C8>= ;854BCH;4 64=4C82 102:6A>D=3 0=3 4=E8A>=<4=C0; 502C>AB %>A4 BCD384B 0A4 =44343 C> 4G0<8=4 C74 45542C >5 C74B4 38554A4=24B >= C74 2;8=820; ?70A<02>:8=4C82B >5 38E4AB4 ?0C84=C ?>?D;0C8>=B $8<8C0C8>=B 8= C78B BCD3H F4A4 => 8=CA0?0C84=C 2><?0A8B>= 14CF44=

(294) <6 >=24308;H 0=3

(295)

(296) <6 CF824308;H. ÓÎ.

(297) Ó{. >«ÌiÀÊÓ\Ê* >À>ViÌVÃÊvÊÃ>µÕ>ÛÀÊ. '%2/# %4380= 2>=24=CA0C8>=B >5 A8C>=0E8A *,.

(298)

(299) <6 >= 30H >5 0A<

(300) A8C>=0E8A

(301) <6 >= 30H >5 0A<

(302) A8C>=0E8A

(303)

(304) <6 >= 30H >5 0A< 0=3 A8C>=0E8A

(305)

(306) <6 >= 30H >5 0A< 80<>=3B 0A<

(307) *,.

(308) <6 >=24308;H >= 30H CA80=6;4B 0A<

(309) *,.

(310) <6 >=24308;H >= 30H B@D0A4B 0A< *,.

(311) <6 >=24308;H >= 30H 2A>BB4B 0A< *,.

(312) <6 CF824308;H >= 30H . 3>B8=6 >=2;DB8>=B A460A38=6 2><?0A8B>= >5 C74B4 CF> A468<4=B B7>D;3 14 3A0F= F8C7 20DC8>= 4B?8C4 A0=3><8I0C8>= 38554A4=C 10B4;8=4 E0;D4B 5>A F4867C F4A4 B44= 14CF44= C74 JABC 0=3 C74 B42>=3 0A< >F4E4A F4 20= 0BBD<4 C70C C74 2>=CA81DC8>= C> C74 38554A4=24B 14CF44= C74 ?70A<02>:8=4C82B >= 30H 0=3 30H 8B ;>F 1420DB4 >5 8=CA0?0C84=C 2><?0A8B>= 867 B0@D8=0E8A ;4E4;B F4A4 B44= 8= 1>C7 0A<B >= 30H $>F 1>3H F4867CB 0C 10B4;8=4 8= 0A<

(313) <867C 2>=CA81DC4 C> C78B 45542C ,74 A4;0C8>=B78? 14CF44= 1>3H F4867C 0=3 B0@D8=0E8A 8B =>C 2;40A H4C >F4E4A 0= 8=E4AB4 2>AA4;0C8>= 14CF44= 1>3H F4867C 0=3 B0@D8=0E8A - F0B >1B4AE43 8= 0 ?A4E8>DB BCD3H 8= ,708 !. ?0C84=CB

(314) ,74 A42><<4=343

(315)

(316) <6 CF824308;H 3>B4 20= 14 DB43 8= ?;024 >5 C74 <6 CF824308;H 3>B8=6 A468<4= B> 0B C> <8=8<8I4 B834 45542CB 20DB43 1H 78674A 3>B4B >5 A8C>=0E8A

(317)

(318)

(319) != >DA BCD3H => B834 45542CB F4A4 B44= 8= C74 >=24308;H 0A< 0A<

(320) '=4 ?0C84=C 703 380AA7>40 >= 1>C7 ?70A<02>:8=4C82 30HB 1DC C78B 383 =>C B44< C> 14 A4;0C43 C> C74 BCD3H 064=CB &> >C74A B834 45542CB F4A4 A4?>AC43 >F4E4A ?0C84=CB F4A4 C>;4A0C8=6 B0@D8=0 E8A A8C>=0E8A 5>A 0 <8=8<D< >5 F44:B 0=3 0 <40= >5 F44:B 145>A4 C78B ?70A<02>:8=4C82 BCD3H &4E4AC74;4BB 0B 0 A4BD;C >5 78674A 3>B4B >5 B0@D8=0E8A >A A8C>=0E8A 0338C8>=0; B834 45542CB <867C 70E4 0??40A43 F8C7 8=C0:4 5>A ;>=64A C70=

(321) F44: 7867 ?8;; 1DA34= 8B 0 ?>C4=C80; 38B03E0=C064 >5 ?A>C40B4 8=7818C>AB 8= 64=4A0; 70=68=6 C74 B0@D8=0E8A 3>B4 5A>< 0 CF824308;H C> >=24308;H A468<4= 8=2A40B4B C74 =D<14A >5 B0@D8 =0E8A 20?BD;4B C> 14 C0:4= 0C C74 B0<4 C8<4 5A>< JE4 8= C74 CF824308;H A468<4= C> 14CF44= 4867C 0=3

(322) 8= C74 >=24308;H A468<4= =4F <6 5>A<D;0C8>= >5 B0@D8=0E8A 8B 2DAA4=C;H 148=6 34E4;>?43 /8C7 C74 =4F 5>A<D;0C8>= 0 A43D2C8>= 8= 308;H ?8;; 2>D=C 20= 14 02784E43 ,74 A4BD;CB 5A>< >DA BCD3H 70E4 B7>F= C70C

(323) <6 >=24308;H >A

(324)

(325) <6 CF824308;H F>D;3 A4BD;C 8= <>A4 50E>DA01;4 ?70A<02>:8=4C82 ?0A0<4C4AB C70= C74

(326)

(327) <6 >=24308;H 3>B064 0=3 ?A4BD<01;H C74 =4F 5>A<D ;0C8>= 0;C4A=0C8E4 3>B064 >5

(328)

(329) <6 >=24308;H 0B F4;; ,74 2A8C820; ?70A<02>:8=4C82 ?0A0<4C4A C70C 14BC ?A4382CB ,1 8,82 0=C8E8A0; 45J202H >5 1>>BC43 B0@D8=0E8A 70B =>C 144= 34C4A<8=43 ,74 2;8=820; 45J202H >5 C74 B0@D8=0E8A A8C>=0E8A

(330)

(331) <6 CF824308;H A468<4= 70B 144= 34<>=BCA0C43 8= C74 %0G<8= CA80;B

(332) ,74A4 8B 0 2>=24A= C70C C74

(333)

(334) <6 >=24308;H 3>B4 8B C>> ;>F 2><?0A43 F8C7 C74 A42><<4=343

(335)

(336) <6 CF824308;H A468<4= A4BD;C8=6 8= 0 ;>F4A CA>D67. ;4E4; 0=3 2>=B4@D4=C;H 0= 8=2A40B43 ;8:4;87>>3 >5 B4;42C8=6 3AD6A4B8BC0=C !. BCA08=B != >DA BCD3H C7A44 ?0C84=CB >=

(337)

(338) <6 >=24308;H 703 CA>D67 ;4E4;B ;>F4A C70= C74 A42><<4=343 C0A64C CA>D67 ;4E4; 5>A CA40C<4=C=08E4 ?0C84=CB F8C7 F8;3CH?4 E8ADB

(339) 4B?8C4 C74B4 ;>F ;4E4;B C74 ?0C84=CB 703 E8A>;>6820; BD??A4BB8>= D? C> F44:B != 0 ?A4E8>DB BCD3H F8C78= C74 !.&,

(340) CA80; B4A84B ;>F CA>D67 ;4E4;B F4A4 0;B> B44= F8C7 B0@D8=0E8A

(341)

(342) <6 >F 4E4A ?0C84=CB B054;H BF8C2743 5A><

(343)

(344) <6 >=24308;H B0@D8=0E8A B>5C 64; 20?B C>

(345)

(346) <6 >=24308;H B0@D8=0E8A 70A3 64; 20?B 0=3 <08=C08=43 C748A 8<<D=>;>6820; 0=3 E8A>;>68 20; A4B?>=B4 F8C7>DC 0338C8>=0; B834 45542CB /74C74A C78B <40=B C70C 0 ;>F4A CA>D67 ;4E4; 8B 0224?C01;4 C70C C74 2>=2><8C0=C &*,!B 0A4 >5 <>A4 8<?>AC0=24 >A ?4A70?B C70C 8=CA024;;D;0A B0@D8=0E8A 2>=24=CA0C8>= 8B C74 :4H ?0A0<4C4A 5>A ?A4382C8=6 0=C8 E8A0; 45J202H 8B 385J2D;C C> B0H %>A4>E4A 8= 1>C7 C74 ?A4 E8>DB;H <4=C8>=43 BF8C27 BCD3H 0=3 >DA ?A4B4=C BCD3H C74 45542CB >5 B4;42C8>= 180B 20==>C 14 AD;43 >DC 1420DB4 ?0C84=CB F4A4 DB8=6 B0@D8=0E8A 70A3 64; 20?B

(347)

(348) <6 >=24308;H ;>=6 C4A< != 2>=2;DB8>= 3>B8=6 >5 B0@D8=0E8A A8C>=0E8A 0B

(349) <6 >=24308;H >A

(350)

(351) <6 CF824308;H A4BD;C43 8= 8=2A40B43 B0@D8=0E8A - 0=3 <8= F74A40B C74 B0@D8=0E8A <0G >=;H 8=2A40B43 F74= 3>B43 0B <6 >C7 3>B4A468<4=B 20= 14 DB43 8= 2;8=820; ?A02C824 >B8=6 0B

(352) <6 8B 0= 0CCA02C8E4 >?C8>= 1420DB4 >5 C74 2>=E4= 84=24 >5 >=24308;H 3>B8=6 >F4E4A 8C 20= 14 7H?>C74B8I43 C70C 8= ?0C84=CB F8C7 E8A0; A4B8BC0=24 C74 CF824308;H A468<4= F>D;3 A4BD;C 8= 14CC4A >DC2><4B 1420DB4 >5 7867 B0@D8=0E8A ;4E4;B 3DA8=6 C74 4=C8A4 3>B8=6 8=C4AE0; /74C74A >=4 >5 C74B4 A468<4=B 70B 14CC4A 2;8=820; 45J202H =443B C> 14 8=E4BC860C43 8= 0 ;0A64A 2;8=820; CA80; DAC74A<>A4 BCD384B 0A4 A4@D8A43 C> 4BC01;8B7 F74C74A - <8= >A ?4A70?B 0=>C74A ?70A<02>:8=4C82 ?0A0<4C4A B7>D;3 14 C74 ?A8<0AH 2>= B834A0C8>= F74= 4E0;D0C8=6 ?70A<02>:8=4C82 E0;D4B 0BB>280C43 F8C7 38554A4=C B0@D8=0E8A A8C>=0E8A 3>B8=6 A468<4=B. !(+,4)#"%#*#+10 4A38=0=3 /8C !, +C0220C> ;8=820; ,A80; C40< !.&, 0=3 ,708 *43 A>BB 83B *4B40A27 4=CA4 *>274 (70A<024DC8 20;B (70A<0224BB 0=3 !,. #$#/#+!#0 #AK>7 35=

(353). &D;@5;B>7E 3@6 BD35F;57 A8 , BDAF73E7 ;@:;4;FAD B:3D?35A7@:3@57?7@F !!$ N . !GDAIE=; # )F7D@87>6 * )3IK7D * "

(354). &:3D?35A =;@7F;5 3@6 FA>7D34;>;FK BDAM>7 A8 FI;5763;>K E3CG;@3H;D :3D6 97>3F;@ 53BEG>7E 3@6 E3CG;@3H;D EA8F 97>3F;@ 53BEG>7E 4AAEF76 I;F: D;FA@3H;D ;@ :73>F:K HA>G@F77DE !!$

(355) N . 3D6;7>>A & #A@:3B:A> * #3:3@A@F:3D;F * "

(356). &:3D?35A=;@7F;5E A8 A@5763;>K E3CG;@3H;D :3D697>3F;@ 53BEG>7E 3@6 E3CG;@3H;D EA8F97>3F;@ 53BEG>7E 4AAEF76 I;F: D;FA@3H;D ;@ , ;@875F76 EG4<75FE %+($" % '+!( ##+$

(357) .!$- -$(%#) N

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