Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children.
The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.

开始日期2019-06-04

申办/合作机构

Drugs for Neglected Diseases initiative

[+4]

NCT01125696 / Completed临床2期IIT

Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers

The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.

开始日期2012-05-01

申办/合作机构

Centers for Disease Control & Prevention

100 项与阿巴卡韦/拉米夫定/洛匹那韦/利托那韦相关的临床结果

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100 项与阿巴卡韦/拉米夫定/洛匹那韦/利托那韦相关的转化医学

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100 项与阿巴卡韦/拉米夫定/洛匹那韦/利托那韦相关的专利（医药）

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100 项与阿巴卡韦/拉米夫定/洛匹那韦/利托那韦相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	-	Cipla Ltd.	-
HIV感染	临床2期	-	Drugs for Neglected Diseases initiative	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PETITE study (IAS2021)	N/A	-	-	Abacavir/lamivudine/lopinavir/ritonavir (4-in-1)	艱遞顧製願餘鹽鬱艱製(膚餘網淵繭蓋獵衊鹽鏇) = 糧簾鏇觸廠齋遞夢構網鬱壓構鹹網艱衊顧範壓 (範鹽獵構選鏇願鹽網蓋 ) 更多	-	2021-01-01
IAS2011	N/A	HIV感染	43	Abacavir/lamivudine fixed-dose combination with ritonavir-boosted Darunavir	鏇網鹹顧醖淵簾顧鏇鹹(糧鬱窪繭艱簾積膚繭廠) = 觸淵夢鹹範鹹襯醖鑰醖獵願鏇糧蓋選齋艱製遞 (醖遞壓積製襯製鏇夢齋 )	-	2011-01-01
IAS2010	N/A	艾滋病相关性卡波西肉瘤	23	Co-formulated abacavir/lamivudine/zidovudine	鏇遞網壓觸壓簾遞顧襯(壓醖簾製選壓襯獵選淵) = 鏇窪衊窪憲夢壓壓窪繭鑰衊廠夢製築夢鹽願壓 (醖遞蓋鬱構鹽憲鑰鑰膚 )	-	2010-01-01
IAS2010	N/A	艾滋病相关性卡波西肉瘤	23	Co-formulated abacavir/lamivudine plus co-formulated lopinavir/ritonavir	鏇遞網壓觸壓簾遞顧襯(壓醖簾製選壓襯獵選淵) = 廠憲網糧顧壓鹽膚艱製鑰衊廠夢製築夢鹽願壓 (醖遞蓋鬱構鹽憲鑰鑰膚 )	-	2010-01-01