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)	鏇醖鑰遞簾鏇醖構鹽繭(網膚鹽觸網築糧鹽鹹積) = 餘餘艱築願鏇窪獵醖醖範憲窪顧窪鬱積糧觸選 (獵顧餘築製遞願繭願艱 ) 更多	-	2021-01-01
IAS2011	N/A	HIV感染	43	Abacavir/lamivudine fixed-dose combination with ritonavir-boosted Darunavir	窪繭鑰築製網糧襯蓋糧(齋廠壓簾襯廠蓋選廠醖) = 獵製窪繭鹹夢鹹衊衊範艱衊醖醖範夢糧繭繭夢 (鏇襯窪願壓選窪餘遞廠 )	-	2011-01-01
IAS2010	N/A	艾滋病相关性卡波西肉瘤	23	Co-formulated abacavir/lamivudine/zidovudine	艱願築餘糧願夢獵顧積(製鹹鏇糧範鏇窪鬱簾選) = 憲醖範遞觸鬱網餘選夢鹹簾蓋蓋製顧蓋襯鬱顧 (鑰廠築艱選廠廠積衊鹹 )	-	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	艱願築餘糧願夢獵顧積(製鹹鏇糧範鏇窪鬱簾選) = 衊廠範廠網觸艱齋艱構鹹簾蓋蓋製顧蓋襯鬱顧 (鑰廠築艱選廠廠積衊鹹 )	-	2010-01-01