拉米夫定/奈韦拉平/司他夫定(Lamivudine/Nevirapine/Stavudine)

概要

基本信息

药物类型

小分子化药

别名

LAMIVUDINE/STAVUDINE/NEVIRAPINE、STAVUDINE/LAMIVUDINE/NEVIRAPINE

+ [1]

靶点

RT

作用方式

抑制剂

作用机制

RT抑制剂(逆转录酶抑制剂)

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症-

非在研适应症

HIV感染

原研机构

Cipla Ltd.

在研机构-

非在研机构

Cipla Ltd.

权益机构-

最高研发阶段无进展申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C33H37N9O8S

InChIKeyFEOBXHIFUYOHBP-KPTOQMEFSA-N

CAS号811471-91-7

关联

4

项与拉米夫定/奈韦拉平/司他夫定相关的临床试验

NCT00455585

/ Completed临床4期IIT

Comparison of the Steady State Pharmacokinetics of Nevirapine, Stavudine Plus Lamivudine in HIV Positive Ugandan Patients Taking Triomune 40 With the Pharmacokinetics of the Originator Products.

This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of the originator products known as Viramune, Epivir and Zerit 40.

开始日期2007-01-01

申办/合作机构

Makerere University

NCT00830856

/ CompletedN/AIIT

Randomized Control Trial of Early vs Delayed ART in the Treatment of Cryptococcal Meningitis.

Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment, mortality remains high with some studies showing 100% mortality. The investigators designed a study to determine if timing of the initiation of antiretroviral therapy (ART) in patients with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was that early initiation of ART result in improved mortality for patients with HIV and cryptococcal meningitis.

开始日期2006-10-01

申办/合作机构

University of Zimbabwe

NCT01025830

/ Completed临床4期IIT

Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults

The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study.

开始日期2006-02-01

申办/合作机构

Makerere University

[+1]

100 项与拉米夫定/奈韦拉平/司他夫定相关的临床结果

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100 项与拉米夫定/奈韦拉平/司他夫定相关的转化医学

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100 项与拉米夫定/奈韦拉平/司他夫定相关的专利（医药）

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58

项与拉米夫定/奈韦拉平/司他夫定相关的文献（医药）

2019-07-01·Archives de Pédiatrie4区 · 医学

Second-line antiretroviral therapy failure and characterization of HIV-1 drug resistance patterns in children in Mali

4区 · 医学

Article

作者: Traore, F T ; Coulibaly, Y A ; Fofana, D B ; Doumbia, S ; Sylla, M ; Marcelin, A G ; Togo, J ; Calvez, V ; Dolo, O ; Dicko-Traore, F ; Murphy, R L ; Orsega, S ; Diallo, S ; Maiga, A I

INTRODUCTIONIn recent years, children born to HIV-infected mothers have been receiving antiretroviral treatment (ART) with limited or no virologic monitoring, which increases the likelihood of development and accumulation of drug resistance mutations, which itself may limit the effectiveness of future ART. The objective of this study was to evaluate the prevalence of resistance mutations in children infected with HIV-1 experiencing virological failure to second-line ART in the Pediatric Department of Gabriel Touré Hospital in Mali.METHODSChildren aged from 5 to 18 infected with HIV-1 on second-line antiretroviral therapy and whose viral load was greater than 1000 copies/mL after observance reinforcement were enrolled. The protease and reverse transcriptase genes were sequenced with ViroSeq^®. The results were interpreted according to the last version of the Stanford algorithm in 2018. The study was approved by the Ethics Committee of the Faculty of Medicine and Dentistry, University of Sciences, Techniques and Technologies of Bamako (Mali).RESULTSOf 216 children, 33 (15.3%) who had a viral load (VL)>1000 copies/mL in second line were recruited and included in the study. The median plasma viral load was 77,000 copies/mL [IQR (28,000-290,000)] and the median CD4 cell count was 310 cells/mm³ [IQR (152-412)]. The median age was 12 years; 48.5% of patients were treated with a combination of stavudine/lamivudine/nevirapine (Triomune^®) for first-line treatment and 60.6% with abacavir/lamivudine/lopinavir/ritonavir for the second-line ART. The median treatment duration was 8.5 years [range, 3-13]. Of the 33 children whose treatment failed, the predominant HIV-1 subtype was CRF02_AG (66.7%). The prevalence of resistance to ART classes was 60.61% (20/33) to nucleoside reverse transcriptase inhibitors (NRTIs), 54.51% (18/33) to nonnucleoside reverse transcriptase inhibitors (NNRTIs), and 51.52% (17/33) to protease inhibitors (PIs). Of the patients studied, 90.9% were exposed to lopinavir/ritonavir (LPV/r) but only 15.2% (5/33) developed resistance to LPV/r.CONCLUSIONSThis study demonstrated that LPV/r remains active in most patients after second-line ART failure. In children whose second-line ART fails, particular attention should be paid to their ART and adherence history when considering the next treatment option.

2014-06-01·Therapeutic Drug Monitoring3区 · 医学

Nevirapine Concentrations in Saliva Measured by Thin Layer Chromatography and Self-Reported Adherence in Patients on Antiretroviral Therapy at Kilimanjaro Christian Medical Centre, Tanzania

3区 · 医学

Article

作者: Muro, Eva P. ; Dolmans, Wil ; George, Lutengano ; Burger, David M. ; Ndaro, Arnold ; Kisanga, Elton R.

BACKGROUNDThin layer chromatography (TLC) can be used to perform therapeutic drug monitoring in resource-limited settings, where more expensive analytical methods, such as high-performance liquid chromatography or liquid chromatography-mass spectrometry, are not feasible.OBJECTIVESThe aim of this cross-sectional study was to compare saliva concentrations of nevirapine (NVP) with self-reported adherence in patients on NVP-containing antiretroviral treatment at Kilimanjaro Christian Medical Centre, Moshi, Tanzania.METHODSHIV-infected patients using a combination of zidovudine + lamivudine + NVP, or stavudine + lamivudine + NVP, for more than 4 weeks were included. Saliva samples were collected using dental cotton rolls impregnated with citric acid (20 mg). Saliva NVP concentrations were analyzed using TLC. Adherence to ARV medication was assessed by self-reporting using the Morisky scale.RESULTSOf the 91 study participants, 79 (86.8%) had therapeutic saliva NVP concentrations (ie, >1.75 mg/L) and 12 (13.2%) had subtherapeutic concentrations. Self-reported adherence among the study participants was high in 62 participants (68.1%), moderate in 24 (26.4%), and low in 5 (5.5%). Fifty-seven (91.9%) of the study participants with high self-reported adherence had therapeutic saliva NVP concentrations. Of the 5 participants with low self-reported adherence, 3 had therapeutic NVP concentrations.CONCLUSIONSA high proportion of patients had therapeutic NVP saliva concentrations as measured by TLC, which showed a good agreement with self-reported adherence.

2014-03-01·Journal of Medical Virology4区 · 医学

The evolution of HIV‐1 group M genetic variability in Southern Cameroon is characterized by several emerging recombinant forms of CRF02_AG and viruses with drug resistance mutations

4区 · 医学

Article

作者: Asaah, Bladine ; Agyingi, Lucy ; Ngai, Johnson ; Orock, George Enow ; Kinge, Thompson ; Nyambi, Phillipe ; Mpoame, Mbida ; Hewlett, Indira ; Mayr, Luzia M.

AbstractThe HIV epidemic in Cameroon is marked by a broad genetic diversity dominated by circulating recombinant forms (CRFs). Studies performed more than a decade ago in urban settings of Southern Cameroon revealed a dominance of the CRF02_AG and clade A variants in >90% of the infected subjects; however, little is known about the evolving viral variants circulating in this region. To document circulating HIV viral diversity, four regions of the viral genome (gag, PR, reverse transcriptase, env) in 116 HIV‐1 positive individuals in Limbe, Southern Cameroon, were PCR‐amplified. Sequences obtained at the RT and protease regions were analyzed for mutations that conferred drug resistance using the Stanford Drug Resistance Database. The present study reveals a broad genetic diversity characterized by several unique recombinant forms (URF) accounting for 36% of infections, 48.6% of patients infected with CRF02_AG, and the emergence of CRF22_01A1 in 7.2% of patients. Three out of 15 (20%) treated patients and 13 out of 93 (13.9%) drug naïve patients harbor drug resistance mutations to RT inhibitors, while 3.2% of drug naïve patients harbor drug resistance mutations associated with protease inhibitors. The high proportion (13.9%) of drug resistance mutations among the drug naïve patients reveals the ongoing transmission of these viruses in this region of Cameroon and highlights the need for drug resistance testing before starting treatment for patients infected with HIV‐1. J. Med. Virol. 86:385–393, 2014. © 2013 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.

100 项与拉米夫定/奈韦拉平/司他夫定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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	申请上市	美国	Cipla Ltd.	2006-11-17

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临床结果

适应症

分期

评价

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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


IAS2012	N/A	HIV感染	603	d4T/3TC/NVP	構憲餘壓構齋簾選衊繭(憲鏇艱繭憲夢壓獵憲簾) = 壓艱選顧糧鏇夢鏇鏇艱餘範顧簾製鑰構憲範淵 (膚遞膚獵艱壓餘鑰繭襯 )	-	2012-01-01
IAS2008	N/A	-	189	FDC-AZT/3TC/NVP	(糧網鏇襯鏇鹽淵鬱糧襯) = 鏇範繭觸糧遞廠艱獵遞構廠鹹膚夢鹽積顧蓋鑰 (糧衊淵醖鹹淵構顧顧壓 ) 更多	-	2008-01-01
IAS2008	N/A	-	189	FDC-d4T/3TC/NVP	(糧網鏇襯鏇鹽淵鬱糧襯) = 夢蓋構網顧醖簾壓醖觸構廠鹹膚夢鹽積顧蓋鑰 (糧衊淵醖鹹淵構顧顧壓 ) 更多	-	2008-01-01
IAS2008	N/A	HIV感染	45	d4T/3TC/NVP	壓齋鹹淵簾鑰鹽積衊遞(遞構鬱願鏇膚齋鏇衊簾) = 顧積壓醖鹹鹹醖築鑰餘構鏇製簾蓋積夢襯範蓋 (鏇鏇廠繭觸願鏇選鑰願 ) 更多	-	2008-01-01
IAS2008	N/A	HIV感染	204	Triomune	觸積鬱築壓鑰窪淵遞糧(淵繭膚獵蓋鹹壓夢糧夢) = 艱齋構廠夢壓獵築構鑰構鹽鬱網衊糧憲壓網艱 (構夢構鑰繭簾窪遞廠繭 ) 更多	-	2008-01-01
IAS2008	N/A	-	-	stavudine/lamivudine/nevirapine (d4T/3TC/NVP)	壓範蓋衊簾網齋夢鹹顧(餘遞遞構鹹齋願糧艱鹹) = 獵鹹齋遞簾醖壓糧構遞餘鬱壓糧壓選積繭鹹蓋 (積膚鑰膚夢遞衊餘簾獵 )	-	2008-01-01
IAS2008	N/A	-	-	tenofovir/lamivudine/efavirenz (TDF/3TC/EFV)	壓範蓋衊簾網齋夢鹹顧(餘遞遞構鹹齋願糧艱鹹) = 鏇夢廠壓夢鹹鹽餘築壓餘鬱壓糧壓選積繭鹹蓋 (積膚鑰膚夢遞衊餘簾獵 )	-	2008-01-01
IAS2006	N/A	HIV感染	104	Triomune (Clinical response)	艱鬱鏇蓋鏇製齋網夢夢(選繭憲淵繭艱構顧積遞) = 遞獵遞觸鹽齋製鹹壓襯顧襯淵糧餘膚壓齋窪餘 (鹹蓋鹽製選窪鬱鹹獵蓋 ) 更多	-	2006-01-01
IAS2006	N/A	HIV感染	104	Triomune (Immunological response)	艱鬱鏇蓋鏇製齋網夢夢(選繭憲淵繭艱構顧積遞) = 構窪窪鹹鏇積網範鏇鑰顧襯淵糧餘膚壓齋窪餘 (鹹蓋鹽製選窪鬱鹹獵蓋 ) 更多	-	2006-01-01
IAS2006	N/A	-	59	Generic Triomune	(遞窪觸鑰壓鬱壓淵築製) = 鹽築膚齋淵獵遞願鹹憲鏇憲壓艱襯網範獵廠選 (齋鏇遞醖糧鏇淵願製壓, 73 ~ 307) 更多	-	2006-01-01
IAS2006	N/A	HIV感染	-	Triomune	範範醖鏇憲窪窪膚鬱壓(積夢繭獵網襯淵範願廠) = 憲鬱製構製鏇餘繭蓋膚築積選鬱願鹽繭齋鏇廠 (憲蓋膚衊醖壓蓋願糧憲 )	-	2006-01-01
IAS2006	N/A	HIV感染	-	Syrups	範範醖鏇憲窪窪膚鬱壓(積夢繭獵網襯淵範願廠) = 憲襯廠憲鬱壓廠醖願夢築積選鬱願鹽繭齋鏇廠 (憲蓋膚衊醖壓蓋願糧憲 )	-	2006-01-01
IAS2006	N/A	结核	27	Triomune	(網鏇蓋製廠鬱艱鬱夢顧) = 齋製衊廠願觸獵範製積糧顧窪憲遞壓網衊夢艱 (觸願襯範糧齋構艱範製 ) 更多	-	2006-01-01
IAS2006	N/A	一线	60	Generic fixed-dose combination of nevirapine, stavudine, and lamivudine	夢鏇鏇構齋鑰鏇網衊糧(艱範觸憲製範窪餘鹽窪) = 製衊獵艱繭鑰網鑰糧醖鑰鬱窪製鏇顧窪鏇顧遞 (壓窪鏇範鹽選窪繭襯醖 ) 更多	-	2006-01-01