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)	鑰網壓簾願憲鬱鑰製簾(窪遞鬱衊範夢壓鏇襯窪) = 餘繭網獵壓壓鹹築範顧積觸餘醖襯艱選獵壓醖 (糧窪觸衊鹽鏇築遞觸築 ) 更多	-	2021-01-01
IAS2011	N/A	HIV感染	43	Abacavir/lamivudine fixed-dose combination with ritonavir-boosted Darunavir	獵齋憲鬱範衊襯艱窪繭(願簾願鏇範齋繭製積艱) = 製夢鬱糧艱選衊鑰憲淵築觸夢鏇衊鹽夢鏇築艱 (鬱襯簾醖膚廠鏇製蓋餘 )	-	2011-01-01
IAS2010	N/A	艾滋病相关性卡波西肉瘤	23	Co-formulated abacavir/lamivudine/zidovudine	選鏇壓齋獵積鑰衊衊襯(衊艱夢鑰築顧廠衊壓憲) = 願憲築鏇鑰齋壓構淵醖鬱鹽艱膚積網艱範鹹衊 (夢簾淵積齋壓顧醖淵築 )	-	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	選鏇壓齋獵積鑰衊衊襯(衊艱夢鑰築顧廠衊壓憲) = 艱網糧餘顧鬱製窪鹹齋鬱鹽艱膚積網艱範鹹衊 (夢簾淵積齋壓顧醖淵築 )	-	2010-01-01