SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT04681820 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT01369199 (13) NCT00337467 (13) NCT00098293 (13) NCT01368497 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT02725567 (10) NCT01614470 (10) NCT01423812 (10) NCT00358917 (10) NCT04415268 (10) NCT00511381 (10) NCT03911713 (9) NCT02742519 (9) NCT03045523 (9) NCT00438152 (9) NCT01102972 (9) NCT02971839 (9) NCT00740064 (9) NCT02605954 (9) NCT00379405 (9) NCT01562847 (9) NCT02616783 (9) NCT04272242 (9) NCT02445053 (9) NCT00242840 (9) NCT02724527 (9) NCT04209465 (9) NCT04585737 (8) NCT02082977 (8) NCT00112775 (8) NCT00383318 (8) NCT03659214 (8) NCT03631732 (8) NCT00118898 (8) NCT01888562 (8) NCT02633189 (8) NCT03565692 (8) NCT03843775 (8) NCT01161576 (8) NCT02167165 (8) NCT00344461 (8) NCT04519398 (7) NCT02154490 (7) NCT03232892 (7) NCT00650832 (7) NCT04549025 (7) NCT00440947 (7) NCT02784639 (7) NCT03572140 (6) NCT01237444 (6) NCT00532168 (6) NCT01102569 (6) NCT04424368 (6) NCT01414985 (6) NCT00525733 (6) NCT02308332 (6) NCT01487265 (6) NCT00049933 (5) NCT02389920 (5) NCT03351699 (5) NCT04197934 (5) NCT02272998 (5) NCT00122590 (5) NCT04204330 (5) NCT02450591 (5) NCT01173029 (5) NCT02675829 (5) NCT02858921 (5) NCT01914484 (5) NCT00187733 (5) NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT04625647 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT03058094 (3) NCT01282151 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02684591 (2) NCT02282267 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT03333343 (2) NCT00525473 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00969137 (2) NCT00834665 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT04687241 (2) NCT00005541 (2) NCT01242813 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT04309019 (2) NCT03720665 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04622072 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT03239145 (2) NCT04511533 (2) NCT00226551 (2) NCT02191891 (2) NCT04586270 (2) NCT04669535 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03991013 (2) NCT02500927 (2) NCT04657991 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04646824 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT04657289 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT04429542 (2) NCT01841463 (2) NCT03865511 (2) NCT03205267 (2) NCT01218477 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT04645225 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT04644315 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT04675008 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT04687423 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT03586453 (2) NCT01998295 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT04636437 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) NCT00953706 (2) NCT03795688 (2) NCT02346955 (2) NCT02011945 (2) NCT00857675 (2) NCT00028262 (2) NCT02355431 (2) NCT04575415 (2) NCT02495233 (2) NCT03468985 (2) NCT00230087 (2) NCT02017600 (2) NCT04146298 (2) NCT02036359 (2) NCT04494789 (2) NCT00193947 (2) NCT02349633 (2) NCT02425397 (2) NCT04209816 (2) NCT00959504 (2) NCT03768908 (2) NCT04035486 (2) NCT04619004 (2) NCT00088803 (2) NCT00567359 (2) NCT04040829 (2) NCT02196181 (2) NCT04563871 (2) NCT02231775 (2) NCT03532698 (2) NCT03529084 (2) NCT03433469 (2) NCT02929693 (2) NCT04339829 (2) NCT03295396 (2) NCT03594916 (2) NCT03373760 (2) NCT01961830 (2) NCT02374645 (2) NCT03706287 (2) NCT04164901 (2) NCT03122717 (2) NCT04424966 (2) NCT02588261 (2) NCT01513174 (2) NCT03283826 (2) NCT02578004 (2) NCT00457821 (2) NCT02124044 (2) NCT02847377 (2) NCT03159117 (2) NCT03898908 (2) NCT03433833 (2) NCT02518802 (2) NCT01726738 (2) NCT00362687 (2) NCT03919474 (2) NCT02616393 (2) NCT02736513 (2) NCT02759614 (2) NCT02099058 (2) NCT01677741 (2) NCT02194881 (1) NCT03119831 (1) NCT01248936 (1) NCT03929458 (1) NCT03974022 (1) NCT03137264 (1) NCT01746277 (1) NCT01266369 (1) NCT03548064 (1) NCT01188785 (1) NCT01359436 (1) NCT02113878 (1) NCT03882281 (1) NCT03206372 (1) NCT01955681 (1) NCT03632317 (1) NCT01385722 (1) NCT03496766 (1) NCT02698748 (1) NCT03473665 (1) NCT01179828 (1) NCT01312337 (1) NCT03300414 (1) NCT02447939 (1) NCT04222283 (1) NCT02091999 (1) NCT01964131 (1) NCT03620318 (1) NCT01449461 (1) NCT04238624 (1) NCT04675710 (1) NCT01349660 (1) NCT02000726 (1) NCT00984360 (1) NCT01269424 (1) NCT00062907 (1) NCT04086680 (1) NCT00079326 (1) NCT02938520 (1) NCT02824952 (1) NCT01999270 (1) NCT01589302 (1) NCT00686270 (1) NCT00542841 (1) NCT00409175 (1) NCT01748019 (1) NCT03128749 (1) NCT04682431 (1) NCT02413736 (1) NCT01543113 (1) NCT00138684 (1) NCT02400437 (1) NCT04556305 (1) NCT02014909 (1) NCT03263364 (1) NCT04691375 (1) NCT03343197 (1) NCT03050437 (1) NCT01417442 (1) NCT03083769 (1) NCT00662688 (1) NCT02511340 (1) NCT03678506 (1) NCT02146365 (1) NCT04310943 (1) NCT02619955 (1) NCT02934139 (1) NCT00400387 (1) NCT00375219 (1) NCT00149305 (1) NCT03520946 (1) NCT02787447 (1) NCT04501614 (1) NCT03166631 (1) NCT04213313 (1) NCT02078531 (1) NCT02349048 (1) NCT02981784 (1) NCT04636593 (1) NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT04500717 (1) NCT01074398 (1) NCT03134131 (1) NCT02455167 (1) NCT01004497 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) NCT00867139 (1) NCT03363139 (1) NCT01936051 (1) NCT02341131 (1) NCT00037076 (1) NCT00582907 (1) NCT02169869 (1) NCT03284684 (1) NCT04204473 (1) NCT04678336 (1) NCT01074359 (1) NCT01400191 (1) NCT04530565 (1) NCT03530319 (1) NCT04146402 (1) NCT02658682 (1) NCT04241835 (1) NCT03133234 (1) NCT02251535 (1) NCT00085111 (1) NCT02305095 (1) NCT01645124 (1) NCT03414450 (1) NCT02716246 (1) NCT02308137 (1) NCT04449874 (1) NCT00045942 (1) NCT04604067 (1) NCT03204500 (1) NCT02951052 (1) NCT03236584 (1) NCT03428178 (1) NCT00634595 (1) NCT04677439 (1) NCT02098954 (1) NCT04619563 (1) NCT02463513 (1) NCT03634059 (1) NCT03363217 (1) NCT04381650 (1) NCT01838941 (1) NCT00887562 (1) NCT03934372 (1) NCT04485507 (1) NCT03674502 (1) NCT02075840 (1) NCT01134120 (1) NCT01550640 (1) NCT00737126 (1) NCT00005543 (1) NCT02508532 (1) NCT02722057 (1) NCT02103257 (1) NCT01146132 (1) NCT03365882 (1) NCT00312039 (1) NCT02293733 (1) NCT02906020 (1) NCT00669669 (1) NCT01262352 (1) NCT03268161 (1) NCT03648268 (1) NCT03970447 (1) NCT03594422 (1) NCT02607124 (1) NCT01147445 (1) NCT01260181 (1) NCT03314272 (1) NCT03639714 (1) NCT00152061 (1) NCT04609319 (1) NCT00260897 (1) NCT04551521 (1) NCT01338025 (1) NCT00830245 (1) NCT03593109 (1) NCT00908687 (1) NCT01928940 (1) NCT03045991 (1) NCT03381066 (1) NCT01882205 (1) NCT00405249 (1) NCT04442815 (1) NCT04116502 (1) NCT04079179 (1) NCT01489592 (1) NCT01436656 (1) NCT02130466 (1) NCT02157922 (1) NCT00570401 (1) NCT04622774 (1) NCT01297452 (1) NCT01086267 (1) NCT02928224 (1) NCT01455389 (1) NCT02476851 (1) NCT02961270 (1) NCT02518737 (1) NCT04585750 (1) NCT02359747 (1) NCT01663857 (1) NCT00579683 (1) NCT03602027 (1) NCT01524757 (1) NCT04371848 (1) NCT04436848 (1) NCT02518750 (1) NCT00092391 (1) NCT02070549 (1) NCT00702403 (1) NCT03946748 (1) NCT03654508 (1) NCT04044430 (1) NCT03293524 (1) NCT04133948 (1) NCT01543035 (1) NCT00769587 (1) NCT04448158 (1) NCT00336076 (1) NCT02405247 (1) NCT01453595 (1) NCT03857243 (1) NCT01784939 (1) NCT02806362 (1) NCT00096746 (1) NCT01441128 (1) NCT02652585 (1) NCT03054038 (1) NCT00086957 (1) NCT03336463 (1) NCT04012866 (1) NCT00001566 (1) NCT01482923 (1) NCT04462471 (1) NCT03580655 (1) NCT04173507 (1) NCT01703962 (1) NCT01528774 (1) NCT04485559 (1) NCT00201214 (1) NCT02997228 (1) NCT00395629 (1) NCT03499743 (1) NCT04560413 (1) NCT02460068 (1) NCT01801904 (1) NCT00708162 (1) NCT04418167 (1) NCT03414814 (1) NCT04560894 (1) NCT02666755 (1) NCT02580435 (1) NCT01353625 (1) NCT00233285 (1) NCT04688983 (1) NCT04684147 (1) NCT01225887 (1) NCT01827436 (1) NCT03780738 (1) NCT03559699 (1) NCT01901432 (1) NCT02968303 (1) NCT01328210 (1) NCT00410202 (1) NCT02435927 (1) NCT02931487 (1) NCT01968551 (1) NCT00831974 (1) NCT04201405 (1) NCT02194049 (1) NCT01976104 (1) NCT02695290 (1) NCT01164891 (1) NCT02500147 (1) NCT03721120 (1) NCT01381289 (1) NCT01408589 (1) NCT04012411 (1) NCT03696355 (1) NCT02595944 (1) NCT03670186 (1) NCT01456650 (1) NCT03893357 (1) NCT02606253 (1) NCT03464201 (1) NCT03486496 (1) NCT03883100 (1) NCT00906087 (1) NCT03267654 (1) NCT04427072 (1) NCT02066038 (1) NCT04077372 (1) NCT02400853 (1) NCT03909334 (1) NCT02070536 (1) NCT03562819 (1) NCT00373425 (1) NCT01107418 (1) NCT03502330 (1) NCT03514784 (1) NCT04192292 (1) NCT01709292 (1) NCT02071862 (1) NCT02511288 (1) NCT01570699 (1) NCT02774278 (1) NCT00653666 (1) NCT00618423 (1) NCT00090493 (1) NCT01304602 (1) NCT04316546 (1) NCT03439865 (1) NCT01815255 (1) NCT02023710 (1) NCT04510220 (1) NCT03020095 (1) NCT02707445 (1) NCT01989585 (1) NCT03769103 (1) NCT01531673 (1) NCT02316496 (1) NCT01784419 (1) NCT02089555 (1) NCT02387216 (1) NCT00900185 (1) NCT02547675 (1) NCT04533321 (1) NCT01631279 (1) NCT03621540 (1) NCT01417520 (1) NCT00401999 (1) NCT02326285 (1) NCT04613596 (1) NCT01589445 (1) NCT03686085 (1) NCT01705626 (1) NCT00462943 (1) NCT02133144 (1) NCT04239833 (1) NCT01982955 (1) NCT04537715 (1) NCT01644591 (1) NCT01920204 (1) NCT03678454 (1) NCT00925002 (1) NCT03620669 (1) NCT00708695 (1) NCT01543698 (1) NCT01579630 (1) NCT02385461 (1) NCT03040986 (1) NCT01555697 (1) NCT00090454 (1) NCT03410160 (1) NCT02134015 (1) NCT00274261 (1) NCT04319614 (1) NCT03244956 (1) NCT02961608 (1) NCT01336634 (1) NCT01588145 (1) NCT04603326 (1) NCT01233752 (1) NCT03577314 (1) NCT02086487 (1) NCT00676117 (1) NCT03299049 (1) NCT04226950 (1) NCT03849768 (1) NCT02202200 (1) NCT02956278 (1) NCT03938012 (1) NCT02080715 (1) NCT02364999 (1) NCT04105153 (1) NCT01131325 (1) NCT01116193 (1) NCT01887587 (1) NCT02299622 (1) NCT03803553 (1) NCT00341120 (1) NCT02327169 (1) NCT01738555 (1) NCT02627664 (1) NCT02959749 (1) NCT02032680 (1) NCT00106977 (1) NCT03727763 (1) NCT02296125 (1) NCT03656627 (1) NCT01474551 (1) NCT04142554 (1) NCT01830244 (1) NCT01503164 (1) NCT04077892 (1) NCT02942095 (1) NCT00056550 (1) NCT00503971 (1) NCT03300115 (1) NCT04547946 (1) NCT04581824 (1) NCT02873832 (1) NCT02835599 (1) NCT03064516 (1) NCT00660361 (1) NCT03341494 (1) NCT04220801 (1) NCT04623775 (1) NCT04190628 (1) NCT03840915 (1) NCT03090815 (1) NCT00888134 (1) NCT01019655 (1) NCT03219970 (1) NCT02824458 (1) NCT02170961 (1) NCT00903292 (1) NCT01121575 (1) NCT00040157 (1) NCT00542789 (1) NCT02036177 (1) NCT00470171 (1) NCT01120262 (1) NCT00000912 (1) NCT01550380 (1) NCT04239443 (1) NCT01009814 (1) NCT04001803 (1) NCT00931762 (1) NCT00840190 (1) NCT02330367 (1) NCT00788762 (1) NCT02274337 (1) NCT02720822 (1) NCT00471497 (1) NCT00381654 (1) NCT02169973 (1) NCT01207440 (1) NCT01528085 (1) NCT03982134 (1) NCT02088645 (1) NCT01573494 (1) NCT04644211 (1) NCT03085485 (1) NCT03457220 (1) NCT01928576 (1) NCT03135327 (1) NCT02134886 (1) NCT01497626 (1) NCT00797238 (1) NCT04042701 (1) NCT04006249 (1) NCT02293460 (1) NCT04260022 (1) NCT00160888 (1) NCT02343666 (1) NCT03821363 (1) NCT00378469 (1) NCT03879629 (1) NCT00135447 (1) NCT04297748 (1) NCT02264990 (1) NCT00453609 (1) NCT00068913 (1) NCT04142190 (1) NCT03922061 (1) NCT03356548 (1) NCT02575560 (1) NCT03226223 (1) NCT02531685 (1) NCT00260000 (1) NCT02365441 (1) NCT03762590 (1) NCT03553329 (1) NCT02972333 (1) NCT04056910 (1) NCT04689100 (1) NCT02296996 (1) NCT03151096 (1) NCT02416739 (1) NCT02987829 (1) NCT00565461 (1) NCT02484404 (1) NCT03399669 (1) NCT00730574 (1) NCT00342056 (1) NCT02342353 (1) NCT01259050 (1) NCT03153293 (1) NCT03870828 (1) NCT00041457 (1) NCT02250326 (1) NCT03732703 (1) NCT03396185 (1) NCT03707756 (1) NCT03179436 (1) NCT00737178 (1) NCT04602897 (1) NCT02427893 (1) NCT01648998 (1) NCT02208843 (1) NCT02263638 (1) NCT00299949 (1) NCT01795131 (1) NCT03328078 (1) NCT00625560 (1) NCT04364230 (1) NCT02930954 (1) NCT04425681 (1) NCT02218632 (1) NCT03262779 (1) NCT03855696 (1) NCT00897091 (1) NCT03690115 (1) NCT03186196 (1) NCT02230267 (1) NCT01121172 (1) NCT02115386 (1) NCT01682083 (1) NCT01975727 (1) NCT03113604 (1) NCT04292938 (1) NCT04669938 (1) NCT00866762 (1) NCT02140333 (1) NCT02642042 (1) NCT01854294 (1) NCT01541813 (1) NCT02179814 (1) NCT01730599 (1) NCT02888977 (1) NCT02454933 (1) NCT03693170 (1) NCT01227577 (1) NCT03990181 (1) NCT01134484 (1) NCT04061980 (1) NCT01998841 (1) NCT04413201 (1) NCT03051282 (1) NCT03785249 (1) NCT04619693 (1) NCT03363347 (1) NCT01560104 (1) NCT00222677 (1) NCT04617002 (1) NCT01549314 (1) NCT02601950 (1) NCT01592136 (1) NCT03292133 (1) NCT01723800 (1) NCT01274208 (1) NCT03223155 (1) NCT04677595 (1) NCT00405587 (1) NCT00110513 (1) NCT04044170 (1) NCT02448251 (1) NCT04088188 (1) NCT02601937 (1) NCT02991898 (1) NCT01357941 (1) NCT01848873 (1) NCT01922076 (1) NCT03284502 (1) NCT04117945 (1) NCT00592540 (1) NCT00879632 (1) NCT01353534 (1) NCT01437618 (1) NCT03631706 (1) NCT03595644 (1) NCT04276415 (1) NCT02640287 (1) NCT04546282 (1) NCT00260520 (1) NCT04685135 (1) NCT01439802 (1) NCT01503502 (1) NCT02266641 (1) NCT03943394 (1) NCT04000529 (1) NCT04011293 (1) NCT02484365 (1) NCT03282305 (1) NCT03558607 (1) NCT02555566 (1) NCT03660696 (1) NCT02642016 (1) NCT02416232 (1) NCT03178071 (1) NCT00335244 (1) NCT02888990 (1) NCT00907699 (1) NCT00171912 (1) NCT04646837 (1) NCT02079298 (1) NCT02095782 (1) NCT01387763 (1) NCT03921151 (1) NCT04333472 (1) NCT02520934 (1) NCT01631708 (1) NCT03942094 (1) NCT01697163 (1) NCT00972751 (1) NCT01860534 (1) NCT02504489 (1) NCT04438902 (1) NCT01719367 (1) NCT03132779 (1) NCT03859531 (1) NCT03831646 (1) NCT04487873 (1) NCT02214615 (1) NCT02078388 (1) NCT02690519 (1) NCT03705195 (1) NCT03455829 (1) NCT02260505 (1) NCT01352637 (1) NCT03169127 (1) NCT04322383 (1) NCT02639273 (1) NCT02763098 (1) NCT03551626 (1) NCT03106012 (1) NCT03092674 (1) NCT00154960 (1) NCT03653546 (1) NCT02553811 (1) NCT04098393 (1) NCT00070473 (1) NCT04606771 (1) NCT01618383 (1) NCT01351324 (1) NCT03711422 (1) NCT00129532 (1) NCT03885830 (1) NCT03731013 (1) NCT04507919 (1) NCT01956227 (1) NCT00362466 (1) NCT04534283 (1) NCT03227926 (1) NCT04233346 (1) NCT03991403 (1) NCT01594723 (1) NCT00772876 (1) NCT04138485 (1) NCT01105169 (1) NCT00593476 (1) NCT02576080 (1) NCT01699711 (1) NCT03916185 (1) NCT01877811 (1) NCT01949909 (1) NCT03140761 (1) NCT03492801 (1) NCT03475004 (1) NCT01875653 (1) NCT03977584 (1) NCT02979769 (1) NCT04324112 (1) NCT02398825 (1) NCT01523171 (1) NCT03235505 (1) NCT04140305 (1) NCT00827138 (1) NCT03943342 (1) NCT00632632 (1) NCT01349465 (1) NCT01641107 (1) NCT02815137 (1) NCT03405194 (1) NCT01888926 (1) NCT01108627 (1) NCT04525768 (1) NCT03787056 (1) NCT01275196 (1) NCT02633943 (1) NCT01513356 (1) NCT02350426 (1) NCT02143050 (1) NCT03198897 (1) NCT04541082 (1) NCT03975114 (1) NCT02786381 (1) NCT00896727 (1) NCT02707562 (1) NCT03349931 (1) NCT02842177 (1) NCT03482362 (1) NCT02469974 (1) NCT03721289 (1) NCT03812172 (1) NCT01730911 (1) NCT00752076 (1) NCT04467853 (1) NCT04603885 (1) NCT02468661 (1) NCT01105351 (1) NCT01599364 (1) NCT00126880 (1) NCT00986765 (1) NCT04553081 (1) NCT01259817 (1) NCT01859182 (1) NCT03444090 (1) NCT03190941 (1) NCT03804528 (1) NCT02145234 (1) NCT04006301 (1) NCT03312634 (1) NCT00001721 (1) NCT04120454 (1) NCT02652780 (1) NCT00559026 (1) NCT01955421 (1) NCT03423186 (1) NCT03783975 (1) NCT03207009 (1) NCT03275597 (1) NCT00757783 (1) NCT02672358 (1) NCT00948467 (1) NCT02331966 (1) NCT01738867 (1) NCT02652767 (1) NCT02303041 (1) NCT03874455 (1) NCT02855047 (1) NCT02419287 (1) NCT01667562 (1) NCT02766335 (1) NCT03349983 (1) NCT04278027 (1) NCT03941782 (1) NCT01189435 (1) NCT04242069 (1) NCT03727867 (1) NCT01639092 (1) NCT02146118 (1) NCT00003970 (1) NCT00190177 (1) NCT02025829 (1) NCT02052193 (1) NCT03126799 (1) NCT01949194 (1) NCT02847429 (1) NCT04425187 (1) NCT01121419 (1) NCT03227029 (1) NCT04438005 (1) NCT04329325 (1) NCT00570297 (1) NCT04624373 (1) NCT02043223 (1) NCT03348631 (1) NCT03861156 (1) NCT01660906 (1) NCT02455362 (1) NCT01326741 (1) NCT04338243 (1) NCT03206112 (1) NCT00606307 (1) NCT00586651 (1) NCT03217253 (1) NCT00700414 (1) NCT03325517 (1) NCT02247687 (1) NCT01141023 (1) NCT00603265 (1) NCT02099214 (1) NCT04655092 (1) NCT02949843 (1) NCT03853551 (1) NCT00130078 (1) NCT01043874 (1) NCT03647657 (1) NCT01377025 (1) NCT03581292 (1) NCT04487080 (1) NCT00867334 (1) NCT04285671 (1) NCT03422237 (1) NCT03415126 (1) NCT03136562 (1) NCT03770273 (1) NCT02953522 (1) NCT00879307 (1) NCT03217669 (1) NCT01413685 (1) NCT04487093 (1) NCT02311998 (1) NCT02146963 (1) NCT01534897 (1) NCT03466268 (1) NCT01181505 (1) NCT00562276 (1) NCT01941654 (1) NCT02877212 (1) NCT01136967 (1) NCT02064569 (1) NCT03760458 (1) NCT02651844 (1) NCT04585035 (1) NCT01942993 (1) NCT02284633 (1) NCT03608046 (1) NCT03420079 (1) NCT04330326 (1) NCT00802841 (1) NCT01470209 (1) NCT03457337 (1) NCT04483947 (1) NCT02097472 (1) NCT01411046 (1) NCT01992029 (1) NCT02391623 (1) NCT03594162 (1) NCT01096368 (1) NCT02227693 (1) NCT03122366 (1) NCT01345877 (1) NCT02451852 (1) NCT02886195 (1) NCT01720758 (1) NCT00493103 (1) NCT03585686 (1) NCT04084249 (1) NCT03962647 (1) NCT01734915 (1) NCT03272464 (1) NCT00813514 (1) NCT03787992 (1) NCT02101684 (1) NCT02206763 (1) NCT00553332 (1) NCT01040338 (1) NCT03459534 (1) NCT01950585 (1) NCT01540253 (1) NCT02596113 (1) NCT00880321 (1) NCT00028366 (1) NCT03309462 (1) NCT00540046 (1) NCT01881984 (1) NCT03016377 (1) NCT00000838 (1) NCT01173913 (1) NCT02625519 (1) NCT02649972 (1) NCT03854474 (1) NCT02600260 (1) NCT03472508 (1) NCT03023904 (1) NCT01368523 (1) NCT02960230 (1) NCT02122588 (1) NCT04250545 (1) NCT00262327 (1) NCT00335868 (1) NCT02357732 (1) NCT01717105 (1) NCT00533754 (1) NCT03285750 (1) NCT03377556 (1) NCT01584297 (1) NCT03227861 (1) NCT01583322 (1) NCT02106546 (1) NCT02114177 (1) NCT00285909 (1) NCT01740297 (1) NCT02323100 (1) NCT00280215 (1) NCT01089101 (1) NCT03435939 (1) NCT00957411 (1) NCT02370329 (1) NCT02489903 (1) NCT02956993 (1) NCT04539678 (1) NCT04146181 (1) NCT00875342 (1) NCT02161380 (1) NCT03765775 (1) NCT01283048 (1) NCT04590833 (1) NCT01276743 (1) NCT01402609 (1) NCT02052934 (1) NCT02428543 (1) NCT02311569 (1) NCT01283035 (1) NCT03720873 (1) NCT03189030 (1) NCT02252146 (1) NCT00623220 (1) NCT03176199 (1) NCT00878826 (1) NCT00740545 (1) NCT01871740 (1) NCT02037308 (1) NCT02819804 (1) NCT03455556 (1) NCT03203850 (1) NCT01400451 (1) NCT03718104 (1) NCT01719250 (1) NCT04634994 (1) NCT00216099 (1) NCT04229537 (1) NCT03794297 (1) NCT04271072 (1) NCT01524549 (1) NCT01769911 (1) NCT02454842 (1) NCT03213652 (1) NCT01762046 (1) NCT02569827 (1) NCT03406104 (1) NCT02906202 (1) NCT03877055 (1) NCT03117049 (1) NCT04527666 (1) NCT02989857 (1) NCT01586403 (1) NCT01659151 (1) NCT02504346 (1) NCT02725333 (1) NCT02323126 (1) NCT04426825 (1) NCT01069939 (1) NCT02514174 (1) NCT01227889 (1) NCT01699698 (1) NCT02906696 (1) NCT00878891 (1) NCT03647592 (1) NCT03615105 (1) NCT01013987 (1) NCT04549428 (1) NCT03865082 (1) NCT01670396 (1) NCT03568773 (1) NCT04620330 (1) NCT01352585 (1) NCT02865304 (1) NCT00957476 (1) NCT02186236 (1) NCT01594476 (1) NCT00684307 (1) NCT00005332 (1) NCT02428101 (1) NCT01045525 (1) NCT04609566 (1) NCT02311140 (1) NCT02322255 (1) NCT01744665 (1) NCT01951924 (1) NCT01893554 (1) NCT01390818 (1) NCT01816984 (1) NCT04452877 (1) NCT03225664 (1) NCT02339922 (1) NCT01067781 (1) NCT01858389 (1) NCT03381274 (1) NCT03007043 (1) NCT00874419 (1) NCT00405054 (1) NCT01466660 (1) NCT00873574 (1) NCT03754244 (1) NCT00255658 (1) NCT03845920 (1) NCT02200562 (1) NCT04391283 (1) NCT02722668 (1) NCT00966771 (1) NCT03549689 (1) NCT04489706 (1) NCT04120883 (1) NCT02151981 (1) NCT01002898 (1) NCT02857270 (1) NCT02109653 (1) NCT02960607 (1) NCT01707290 (1) NCT04499989 (1) NCT04043338 (1) NCT03020004 (1) NCT03523065 (1) NCT00723567 (1) NCT00899743 (1) NCT02060526 (1) NCT01362348 (1) NCT03944356 (1) NCT00694161 (1) NCT00522145 (1) NCT03224767 (1) NCT04194203 (1) NCT01669811 (1) NCT03788460 (1) NCT04388904 (1) NCT04075396 (1) NCT02151526 (1) NCT03595917 (1) NCT04092725 (1) NCT01264380 (1) NCT03698318 (1) NCT04104399 (1) NCT03158389 (1) NCT04526782 (1) NCT01254188 (1) NCT02870244 (1) NCT03745326 (1) NCT03911440 (1) NCT00003567 (1) NCT01504542 (1) NCT04480918 (1) NCT00747994 (1) NCT03621865 (1) NCT01281722 (1) NCT02410863 (1) NCT00463385 (1) NCT03243461 (1) NCT01665417 (1) NCT02779530 (1) NCT01837017 (1) NCT02789345 (1) NCT02488694 (1) NCT02924935 (1) NCT03612908 (1) NCT03736837 (1) NCT03110822 (1) NCT03130894 (1) NCT02380157 (1) NCT03818763 (1) NCT02480725 (1) NCT02534168 (1) NCT01259856 (1) NCT04151563 (1) NCT01745120 (1) NCT00595517 (1) NCT02463383 (1) NCT02425904 (1) NCT03965689 (1) NCT04258956 (1) NCT02953496 (1) NCT04034459 (1) NCT03778229 (1) NCT01750918 (1) NCT03386942 (1) NCT03862885 (1) NCT01038856 (1) NCT02631876 (1) NCT01233219 (1) NCT04643847 (1) NCT01597908 (1) NCT03859245 (1) NCT02609984 (1) NCT04592666 (1) NCT04442672 (1) NCT02885766 (1) NCT00854841 (1) NCT04034446 (1) NCT04206072 (1) NCT00607581 (1) NCT01956786 (1) NCT00893178 (1) NCT04640324 (1) NCT04196413 (1) NCT00806325 (1) NCT00364728 (1) NCT04439279 (1) NCT01705847 (1) NCT02561988 (1) NCT04123626 (1) NCT03417830 (1) NCT02922296 (1) NCT01243372 (1) NCT03453918 (1) NCT00513110 (1) NCT04165031 (1) NCT04225429 (1) NCT01006980 (1) NCT00352053 (1) NCT02338011 (1) NCT04360005 (1) NCT02777567 (1) NCT04591002 (1) NCT02367859 (1) NCT03647956 (1) NCT04293562 (1) NCT02628314 (1) NCT03303833 (1) NCT01460134 (1) NCT02929706 (1) NCT03342170 (1) NCT04042558 (1) NCT02626130 (1) NCT03232307 (1) NCT00435513 (1) NCT02317562 (1) NCT01391260 (1) NCT02561533 (1) NCT01980550 (1) NCT00092404 (1) NCT03758677 (1) NCT01001273 (1) NCT03438318 (1) NCT02422797 (1) NCT02318407 (1) NCT02538926 (1) NCT02615015 (1) NCT01284712 (1) NCT04316351 (1) NCT03091491 (1) NCT01740648 (1) NCT01866410 (1) NCT01175161 (1) NCT01602939 (1) NCT04330664 (1) NCT01701037 (1) NCT03612869 (1) NCT00753480 (1) NCT00090688 (1) NCT03590522 (1) NCT01717404 (1) NCT02937727 (1) NCT03899857 (1) NCT04133870 (1) NCT03790397 (1) NCT03024281 (1) NCT03389256 (1) NCT04681001 (1) NCT03426371 (1) NCT02926638 (1) NCT04193553 (1) NCT00997334 (1) NCT04544202 (1) NCT04201457 (1) NCT00618631 (1) NCT04455594 (1) NCT03439215 (1) NCT02164916 (1) NCT02000882 (1) NCT03264794 (1) NCT03810066 (1) NCT01897116 (1) NCT04372498 (1) NCT00125489 (1) NCT02788669 (1) NCT00367952 (1) NCT00977756 (1) NCT03387072 (1) NCT01586195 (1) NCT02611492 (1) NCT01220648 (1) NCT01967940 (1) NCT01708954 (1) NCT03758287 (1) NCT02392871 (1) NCT04401059 (1) NCT02869932 (1) NCT00716014 (1) NCT01526928 (1) NCT00930215 (1) NCT04631172 (1) NCT03228667 (1) NCT04273581 (1) NCT04557956 (1) NCT00980018 (1) NCT01898039 (1) NCT03883087 (1) NCT04364451 (1) NCT04216524 (1) NCT04204551 (1) NCT03672968 (1) NCT03924050 (1) NCT03983252 (1) NCT01639872 (1) NCT02747277 (1) NCT04116918 (1) NCT00669396 (1) NCT02153398 (1) NCT03543306 (1) NCT01377376 (1) NCT01603446 (1) NCT01534520 (1) NCT01972529 (1) NCT01731704 (1) NCT04186377 (1) NCT01424475 (1) NCT02066636 (1) NCT02467270 (1) NCT01748149 (1) NCT02092909 (1) NCT02864251 (1) NCT03846427 (1) NCT03779191 (1) NCT00055848 (1) NCT01217437 (1) NCT04088734 (1) NCT03191786 (1) NCT01450319 (1) NCT04689347 (1) NCT03652090 (1) NCT00995553 (1) NCT01833572 (1) NCT00432900 (1) NCT03553563 (1) NCT01878006 (1) NCT03357627 (1) NCT03668431 (1) NCT03832257 (1) NCT02739243 (1) NCT01193881 (1) NCT02427620 (1) NCT03784599 (1) NCT02055976 (1) NCT02147990 (1) NCT01400074 (1) NCT01551030 (1) NCT00617708 (1) NCT00050180 (1) NCT00283387 (1) NCT03310541 (1) NCT00931944 (1) NCT02730884 (1) NCT02717455 (1) NCT04666259 (1) NCT00532792 (1) NCT04099836 (1) NCT02375022 (1) NCT03709706 (1) NCT02074696 (1) NCT00020787 (1) NCT01739231 (1) NCT04634695 (1) NCT04399551 (1) NCT02590952 (1) NCT02063971 (1) NCT04254419 (1) NCT04654689 (1) NCT01683175 (1) NCT03373370 (1) NCT00814073 (1) NCT02417740 (1) NCT03374215 (1) NCT02783300 (1) NCT03053219 (1) NCT01595425 (1) NCT04128878 (1) NCT01101438 (1) NCT02580708 (1) NCT00769067 (1) NCT03764553 (1) NCT03344809 (1) NCT04009148 (1) NCT02094222 (1) NCT02178722 (1) NCT03452150 (1) NCT04390243 (1) NCT00751777 (1) NCT04676477 (1) NCT02404441 (1) NCT00173069 (1) NCT02311478 (1) NCT01339052 (1) NCT04059874 (1) NCT01833143 (1) NCT00270556 (1) NCT02746341 (1) NCT02977780 (1) NCT02770014 (1) NCT01728025 (1) NCT03866499 (1) NCT03107156 (1) NCT01172509 (1) NCT01822496 (1) NCT04171284 (1) NCT03856697 (1) NCT03648372 (1) NCT03020797 (1) NCT02705846 (1) NCT04552769 (1) NCT00428441 (1) NCT02690324 (1) NCT03521154 (1) NCT01453036 (1) NCT01937325 (1) NCT04206787 (1) NCT04230473 (1) NCT04528680 (1) NCT02383524 (1) NCT01663545 (1) NCT04083976 (1) NCT01754376 (1) NCT04655976 (1) NCT01262482 (1) NCT01074177 (1) NCT00634673 (1) NCT02141464 (1) NCT01999985 (1) NCT02670707 (1) NCT01363570 (1) NCT01586520 (1) NCT03067415 (1) NCT03173820 (1) NCT01487291 (1) NCT00155207 (1) NCT02630264 (1) NCT03257124 (1) NCT01744561 (1) NCT01872780 (1) NCT02762877 (1) NCT04262466 (1) NCT02655536 (1) NCT01139970 (1) NCT02785939 (1) NCT00588263 (1) NCT03919071 (1) NCT01435655 (1) NCT03236675 (1) NCT00668421 (1) NCT03224208 (1) NCT02429791 (1) NCT01711632 (1) NCT03521596 (1) NCT02274012 (1) NCT03101813 (1) NCT03701815 (1) NCT00029627 (1) NCT03001609 (1) NCT01141829 (1) NCT04148898 (1) NCT00443612 (1) NCT02081378 (1) NCT00612898 (1) NCT03972943 (1) NCT04667988 (1) NCT04644887 (1) NCT02785952 (1) NCT00708929 (1) NCT03615443 (1) NCT03548220 (1) NCT01756118 (1) NCT03807778 (1) NCT00671138 (1) NCT00749853 (1) NCT01582997 (1) NCT00815321 (1) NCT01398644 (1) NCT03236610 (1) NCT03053297 (1) NCT02590588 (1) NCT02125357 (1) NCT00245986 (1) NCT04505956 (1) NCT01341743 (1) NCT01339442 (1) NCT02833194 (1) NCT02403193 (1) NCT02630212 (1) NCT02408887 (1) NCT00647946 (1) NCT04396860 (1) NCT01237522 (1) NCT02474355 (1) NCT01761968 (1) NCT03731260 (1) NCT04311034 (1) NCT02091141 (1) NCT01063933 (1) NCT03890198 (1) NCT01789060 (1) NCT03168074 (1) NCT03215706 (1) NCT03588273 (1) NCT02387957 (1) NCT01299337 (1) NCT04148066 (1) NCT03046992 (1) NCT02422719 (1) NCT00173446 (1) NCT02754362 (1) NCT03160105 (1) NCT02782403 (1) NCT02838420 (1) NCT01159145 (1) NCT00794885 (1) NCT04410796 (1) NCT04358562 (1) NCT04143607 (1) NCT04306926 (1) NCT01810965 (1) NCT00433862 (1) NCT00949702 (1) NCT01744171 (1) NCT02314143 (1) NCT02713880 (1) NCT02199613 (1) NCT00687518 (1) NCT02923986 (1) NCT04325698 (1) NCT01014546 (1) NCT04568239 (1) NCT01700582 (1) NCT00672035 (1) NCT03115164 (1) NCT01068327 (1) NCT00464113 (1) NCT01933347 (1) NCT03452592 (1) NCT02186301 (1) NCT01120964 (1) NCT01791309 (1) NCT04629209 (1) NCT00644878 (1) NCT02550990 (1) NCT02965378 (1) NCT03842969 (1) NCT03952052 (1) NCT04484142 (1) NCT01396408 (1) NCT01274091 (1) NCT02412943 (1) NCT02117336 (1) NCT04673331 (1) NCT04607421 (1) NCT01861223 (1) NCT00089297 (1) NCT00570583 (1) NCT01245556 (1) NCT03087071 (1) NCT02292732 (1) NCT02034110 (1) NCT03716908 (1)

SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02881320

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

Cohort 1 and 2: The primary objectives of this study are: Part A: - To evaluate the steady state pharmacokinetics (PK) of bictegravir (BIC) and confirm the dose of the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age) Parts A and B: - To evaluate the safety and tolerability of the adult strength B/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents (12 to <18 years of age) and children (6 to <12 years of age) Cohort 3: The primary objectives of this study are: Part A: - To evaluate the steady state PK of BIC and confirm the dose of B/F/TAF 30/120/15 mg FDC in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg Parts A and B: - To evaluate the safety and tolerability of the low dose B/F/TAF FDC tablet through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg Cohort 4: Group 1: The primary objective of this study is: - To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg FDC TOS (administration of 2 B/F/TAF 15/60/7.5 mg FDC tablets for oral suspension (TOS)) through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets Group 2: The primary objectives of this study are: - To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 15/60/7.5 mg FDC TOS in HIV-1 infected children ≥ 1 month of age, on antiretroviral (ARV) treatment or treatment naive, weighing ≥ 10 to < 14 kg - To evaluate the safety and tolerability of the B/F/TAF 15/60/7.5 mg FDC TOS through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg Group 3: The primary objectives of this study are: - To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg - To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg FDC TOS (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg Group 4: The primary objectives of this study are: - To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg FDC TOS in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg - To evaluate the safety and tolerability of the B/F/TAF 3.75/15/1.88 mg FDC TOS through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

NCT02881320 HIV-1 Infection

6 Interventions

Name: B/F/TAF (Adult Strength)

Description: 50/200/25 mg FDC tablets administered orally once daily without regard to food
Type: Drug
Group Labels: 7

Cohort 1 (12 to Cohort 1 (12 to < Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg) Cohort 2 (6 to Cohort 2 (6 to < Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg) Open-Label Extension

Name: B/F/TAF (Low Dose)

Description: 30/120/15 mg FDC tablets administered orally once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 3 (≥ 2 years of age and weight ≥ 14 to Cohort 3 (≥ 2 years of age and weight ≥ 14 to < Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Open-Label Extension

Name: B/F/TAF (TOS)

Description: 2 x FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) (total dose 30/120/15 mg) administered orally as TOS, once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg) Open-Label Extension

Name: B/F/TAF (TOS)

Description: FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) administered orally as TOS, once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg) Open-Label Extension

Name: B/F/TAF (TOS)

Description: 2 x FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) (total dose 7.5/30/3.75 mg) administered orally as TOS, once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg) Open-Label Extension

Name: B/F/TAF (TOS)

Description: FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) administered orally as TOS, once daily without regard to food
Type: Drug
Group Labels: 4

Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg) Open-Label Extension


Primary Outcomes

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: AUCtau of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Ctau of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24

Time: Up to 24 weeks

Measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24

Time: Up to 24 weeks

Description: AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: AUClast of TAF (Cohort 4)

Time: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Cmax of TAF (Cohort 4)

Time: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Secondary Outcomes

Measure: Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm

Time: Week 24

Measure: Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

Time: Week 48

Measure: Change from Baseline in CD4+ Cell Counts at Week 24

Time: Week 24

Measure: Change from Baseline in CD4+ Cell Counts at Week 48

Time: Week 48

Measure: Change from Baseline in CD4+ Cell Count Percentages at Week 24

Time: Week 24

Measure: Change from Baseline in CD4+ Cell Count Percentages at Week 48

Time: Week 48

Description: Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Tmax of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Cmax of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: AUClast of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: T1/2 of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Apparent Clearance (CL) of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Apparent Vz of Bictegravir

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: AUCtau of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

Measure: PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3)

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose

Description: AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: AUClast of FTC (Cohorts 4)

Time: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.

Measure: PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3)

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose

Description: Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Cmax of FTC (Cohorts 4)

Time: Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Ctau of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Tmax of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: T1/2 of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Apparent CL of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Description: Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.

Measure: PK Parameter: Apparent Vz of TAF and FTC

Time: Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48

Time: Up to 48 weeks

Measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48

Time: Up to 48 weeks

Description: Participants or legal guardian will be asked: if study drug shape and size were acceptable (for Cohort 1 and Cohort 2) about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3) about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

Measure: Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)

Time: Day 1

Description: Participants or legal guardian will be asked about the study drug taste (All Cohorts)

Measure: Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)

Time: Day 1

Description: Participants or legal guardian will be asked: if study drug shape and size were acceptable (for Cohort 1 and Cohort 2) about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3). about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

Measure: Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts)

Time: Week 4

Description: Participants or legal guardian will be asked about the study drug taste (All Cohorts)

Measure: Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)

Time: Week 4

Description: Participants or legal guardian will be asked: about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3). about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

Measure: Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)

Time: Week 24

Description: Participants or legal guardian will be asked about the study drug taste

Measure: Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)

Time: Week 24

Description: Participants or legal guardian will be asked: about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3). about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)

Measure: Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)

Time: Week 48

Description: Participants or legal guardian will be asked about the study drug taste

Measure: Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)

Time: Week 48

Description: Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste

Measure: Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)

Time: Week 1

Description: Participants or legal guardian will be asked about the study drug taste

Measure: Palatability of B/F/TAF Formulation at Week 1 (Cohort 4)

Time: Week 1

Description: Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste

Measure: Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)

Time: Week 2

Description: Participants or legal guardian will be asked about the study drug taste

Measure: Palatability of B/F/TAF Formulation at Week 2 (Cohort 4)

Time: Week 2

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 K65R

m^2 according to the Schwartz Formula - No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening - Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age) - On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment) - For < 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula - 30 mL/min/1.73 --- K65R ---

m^2 using the Schwartz Formula - No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. --- K65R ---


2 M184V

m^2 according to the Schwartz Formula - No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening - Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age) - On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment) - For < 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula - 30 mL/min/1.73 --- K65R --- --- M184V ---

For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. --- M184V ---



HPO Nodes