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ibalizumab ¡A¤½¥q¤w»¡¹L¡A¨S¦³¥æ¤¬§@¥ÎªººÃ¼{¡AAIDSinfo ùرªº¸ê°T«Ü¤F¡A«Ü¦h¤w¹L®É¡A¨S¦³°Ñ¦Ò»ùÈ¡C
Ävª§·íµM¿E¯P¡A²¦³º³o¶ô»æ«Ü¤j¡A¦ý¥H FDA «ØÄ³ªº¥ÎÃÄ guideline(³Ì¤Ö¤GºØ¡A³Ì¦n¤TºØ)¤Î ibalizumab ª`®g¾¯«¬ªºÀuÂI¡A´N·|©ú¥Õ³o´ÚÃīܨãÄvª§¤O¡A²¦³º¤fªAÃĦY¤[¤F§ÜÃĩʷ|³vº¥¥X¨Ó¡A¤@¦ý§ÜÃĩʥX²{¡A¸ÓÃĪº¥«³õ·|º¥º¥µäÁY¡C
HIV ª`®g¾¯«¬³vº¥¿³°_¡A¤é«á¦³¾÷·|¸ò¤fªA¥°_¥§¤¡A²¦³º°Æ§@¥Î¤Ö¤Sªø®Ä¡C
µo²{ªvÀøHIV·sÃĪº¬ãµoÄvª§«D±`¿E¯P,§Æ±æ¤¤¸Îªº¹Î¶¤¦n¦n¥[ªo,¤£¶È¬°¥xÆWª§¥ú,¤]¬°HIV±wªÌ±a¨Ó¥Í¾÷,§ó¯à¬°¤£Â÷¤£±óªº¸Î¤Í̱a¨Ó¤p³¶©¯.
¤£¹L¤p§Ìµo²{¦b¦¹½g¤å³¹¤U¤è¼Ðµù:
Drug Interactions: Ibalizumab drug interactions are currently unknown.
¦Ó¨ä¥LÄvª§ªÌ©Î¦h©Î¤Ö¤]·|¦³©Ò´£¤Î.¦pªGIbalizumabªºDrug Interactions µLªk½T©wªº¸Ü,¬O§_·|³y¦¨FDA¼f®ÖªººÃ¼{?
...¥u¦n¦b³õ¥~¥ª¤â´«¥k¤â...¥Î¥H¬ü¤Æ¦~©³ªº³øªí.....©Ò¥H¤¤©Ê¬Ý«Ý
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http://clinicaltrials.gov/ct2/show/study/NCT01056393?term=Ibalizumab&rank=3
Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient¡¦s HIV treatment.
³oÓSTUDY ¬O±q1/22/2010¶}©l¨ì²{¦bÁÙ¦bÄ~Äò!!!
First received: January 22, 2010
Last updated: April 7, 2014
Last verified: April 2014
¡u¼í®õÂù¶¯¡v¤W¥b¦~°]³ø¬Q¤ÑÂùÂù¥XÄl¡A¶^¯}²³¤H²´Ãè¡C¼í®õ·s¤W¥b¦~À禬¹F63.76»õ¤¸¡A¸û¥h¦~¦P´Á¦~´î11.57¢H¡F¦ýÀò§Q¯à¤O«oÀu©ó¥h¦~¦P´Á¡Aµ|«e²b§Q¹F25.87»õ¤¸¡B¤ñ¥h¦~¦P´Áªº25.73»õ¤¸§e²{¤p´T¦¨ªø¡C¨ä¤¤²Ä¤G©u¥DnÀò§Q°^Äm¨Ó·½¥]¬A¡G¤¤°ê¤j¼íµoªº¥À¤½¥q»´ä°ªøÊ±±ªÑ¡]6808-HK¡^¡B¥H¤Î¼í¦¨±±ªÑ¤½¥qªº«n¤s¤H¹Ø¡B³B¤À¤¤¸Î¥H¤Î°â¥X¡uªQÀÜb¡v1¤áµ¥¡C
¤§«e¼í®õ¦bÁ|¤jºX½æªÑªº®ÉÔ¡A´N²q´ú¬O¼í®õ¦³¬}¦³¸É¡C»Ýnª½±µ»{¦C¤J¼í®õªº¤½¥q±b¡C
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On August 14, 2014, FDA granted tentative approval for a fixed-dose combination consisting of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg, for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents greater than 16 years of age and weighing at least 40 kg.
The application was filed by Macleods Pharmaceuticals Limited of Mumbai, India.
Phase of Development: Phase IIb. Expanded acces (use of a drug outside of a clinical trial) to ibalizumab may be available to patients who qualify for compassionate use treatment. (More details can be found on ClinicalTrials.gov [NCT02028819].)
1.Expanded Access-¡uªvÀø¥Î³~¤§¬ãµo¤¤ÃĪ«ªºÂX¤jµû¦ô(Expanded Access to Investigational Drugs for Treatment Use)¡v³o¶µ·s³W½d³W©w¡A¬ãµo¤¤ªºÃĪ«¥i¥H´£¨Ñµ¹Ó§O¯f±w¡A¥]¬A«æ¶E®É¨Ï¥Î¡F´£¨Ñµ¹¤¤µ¥¤H¼Æªº¯f±w¡F¦bªvÀø³W½d©ÎªvÀø¥Î¬ãµo·sÃĥӽФU´£¨Ñµ¹§ó¦h¤H¡C¬°¤FÂX¤jµû¦ô¨Ï¥Î¡AFDA¥²¶·½T»{¨S¦³¨ä¥L¥O¤Hº¡·N©Î´À¥NªºªvÀø¡A¬°¯f±wªº¥i¯àÀò¯q¶i¦æ·ÀIµû¦ô¡AÂX¤jµû¦ô¨Ã¤£·|¤zÂZ¼Ð·Çªº®Öã¹Lµ{¡C¥t¤@¶µ³W©w¡B¡u¬ãµo·sÃĥӽФU¨Ï¥Î¬ãµo¤¤ÃĪ«¤§¦¬¶O(Charging for Investigational Drugs Under an Investigational New Drug Application)¡v¡AÂç²M¯S©wªº¨Ï¥Îª¬ªp¥H¤Î¦¬¶OÃþ§O¡AÅýÃļt¦bÁ{§É¸ÕÅç½d³ò©Î«DÄÝÁ{§É¸ÕÅç®É¡A¥i¥H¦V¯f±w¦¬¨ú¬ãµo¤¤ªºÃĪ«¶O¥Î¡C¤]Âç²M¬ãµo»s¾¯À³²[»\þ¨Ç¶O¥Î¡C(http://www.24drs.com/professional/list/content.asp?x_idno=5827&x_classno=0&x_chkdelpoint=Y)
2.More details can be found on ClinicalTrials.gov [NCT02028819]-(http://www.clinicaltrials.gov/ct2/show/NCT02028819?term=NCT02028819&rank=1),(https://www.collectiveip.com/clinical-trials/NCT02028819)
3.¦¹¥~¦b¬ü°êU.S. National Institutes of Health(457´Á°]°T¤¶²Ðªº¬ü°ê°ê®a½Ã¥Í°|ºô¯¸)¬ÛÃöºô¶¬Ý¨ìTaiMed Biologics Inc.(¤¤¸Î)¬ÛÃö¸ê°T¨Ñ¦U¦ì¤j¤j°Ñ¦Ò(http://www.clinicaltrials.gov/ct2/results?term=TaiMed+Biologics+Inc.+&Search=Search)
http://www.otc.org.tw/web/emergingstock/single_historical/history.php?l=zh-tw
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