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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{?

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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.

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First received: January 22, 2010

Last updated: April 7, 2014

Last verified: April 2014

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HIV/AIDS Update - Tentative approval of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg

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.

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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)

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