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.

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

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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31

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.

2014-07-01·Nature Medicine1区 · 医学

European-African clinical research scheme expands into phase 1

1区 · 医学

作者: Zeliadt, Nicholette

Before the launch of the EDCTP a decade ago, few African groups outside of the northern countries and South Africa were capable of conducting clin. trials that met international standards, according to Abdoulaye Djimde,́ an EDCTP-funded malaria researcher at the University of Bamako in Mali."The advent of EDCTP was really a game changer, in terms of not only investing in training Africans so that they can run the trials themselves but also in demonstrating that it can be done."A few projects funded in part by the EDCTP have already posted some promising results.For example, one study conducted at five sites in Burkina Faso, Kenya and South Africa showed that three antiretroviral drugs given in combination throughout pregnancy and breastfeeding are more effective at preventing the transmission of HIV from pregnant women or breastfeeding mothers to their children than the conventional regimen consisting of two antiretroviral agents given during pregnancy and one week after delivery (Lancet Infect. Dis.11, 171-180, 201110.1016/S1473-3099(10)70288-7).Those results contributed to the revision in 2010 of the World Health Organization′s guidelines for the prevention of mother-to-child transmission of the virus to recommend triple-antiretroviral therapy during pregnancy and breastfeeding.Other EDCTP-backed studies led to the approval by the US Food and Drug Administration of two anti-HIV drug combinations formulated especially for children-Triomune Baby and Triomune Junior, manufactured by the India-based pharmaceutical company Cipla.Despite the program′s relatively limited scientific achievements thus far, Gray says it has made great strides in training scientists and establishing collaborations.For example, the EDCTP has launched four African Regional Networks of Excellence promoting partnerships between researchers in the continent (see Nat. Med.16, 9, 201010.1038/nm0110-9a).It has also been credited with helping to establish ethics committees and regulatory frameworks in many African countries and providing funds to the South African Cochrane Center to establish the Pan African Clin. Trials Registry, a repository of information about the studies conducted on the continent.The new phase of the program seeks to leverage the capacity developed during the past decade to expand its focus to include neglected infectious diseases such as schistosomiasis, African sleeping sickness, diarrheal diseases and respiratory infections."Now that we have this structure, why not add a little bit more, because it′s more cost effective," says EDCTP executive director Charles Mgone."It′s like we already have the mother ship, and the other satellites can come and dock on it."Also, for the first time, the EDCTP is granting full membership to African countries-putting them on an equal footing with European members when it comes to governance, policy decision-making and participation in the program-in exchange for an annual contribution of at least [euro]200,000.Membership gives African countries a financial stake in EDCTP-funded projects and will help to ensure that the research agenda is aligned with the health needs of the continent.As of early May, nine sub-Saharan African countries had joined the partnership.As the program unfolds in the coming months and years, Mgone says that the EDCTP is looking for new ways to collaborate with other funding organizations and pharmaceutical companies.Industry has traditionally participated in EDCTP-funded projects by developing and donating drugs and vaccines to clin. studies, but Mgone hopes to form collaborations that will build even more capacity and fund bigger trials than before.As an example of what′s possible, Mgone points to the Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA), an alliance between three European universities, 12 African clin. trial sites and the pharmaceutical companies Bayer, Sequella and Sanofi-Aventis that was established by the EDCTP in 2008 to simplify and shorten the duration of tuberculosis treatment.In addition, the EDCTP developed a fellowship scheme in 2013 that enables African researchers to work for 6-18 mo at European pharmaceutical companies to gain advanced skills and expertise related to clin. trials."We′re really looking to make [EDCTP2] more of a joint partnership between the developing and developed countries," Mgone says."The initial phase was to kick-start the engine," he says, "but if things are moving, you need to crank up the machinery."

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

Drug resistance mutations and genetic diversity in adults treated for HIV type 1 infection in Mauritania

4区 · 医学

Article

作者: Ould Soufiane, Sid'Ahmed ; Ould Horma Babana, Abdallah ; Kane, Coumba Touré ; Mboup, Souleymane ; Lo, Baidy ; Tchiakpé, Edmond ; Diop‐Ndiaye, Halimatou ; Mouhamedoune Baye, Abderrahmane ; Fall‐Malick, F‐Zahra

AbstractThe aim of this cross‐sectional study was to evaluate the drug resistance mutationprofile observed in patients receiving antiretroviral therapy with virological failure and to document the HIV‐1 genetic diversity in Mauritania. Eighty‐six subjects were included and 65 samples were amplified successfully and sequenced. HIV‐1 genotyping was performed using the Agence Nationale de Recherche sur le SIDA AC11 resistance procedure. The median treatment duration was 32 months (range: 6–88) and the median viral load, 5 log10 copies/ml (range: 3.13–7). Fifty‐nine patients (90.8%) were on first line regimens including 32.0% (19/59) on triomune fixed‐dose and six on second‐line therapy with NonNucleoside Reverse Transcriptase plus a protease inhibitor. Forty‐seven patients (72.3%) had at least one drug resistance mutation including 73.0% (43/59) on first‐line therapy. For the second‐line, one out of six patients presented resistance mutations and only one presented PI DRM. Overall, the most common DRMs detected were M184V/I (n = 32; 49.2%), K103N (n = 28; 43%), and Y181C (n = 13; 20%). Thymidine Analog Mutations (TAMs) were found in 26.0% (n = 17) of strains and the most common was T215Y (n = 11, 16.9%). Phylogenetic analysis revealed 17 HIV‐1 variants with the predominance of CRF02_AG (n = 42; 64.6%). A high rate of DRM was found in this study and shows the potential need for a structured virological surveillance including viral load quantification and genotyping. Further studies may also be needed in regards to the great variability of HIV‐1 strains in Mauritania. J. Med. Virol. 86:404–410, 2014. © 2013 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

10 条进展最快的记录,

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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	築淵夢觸獵齋鑰艱淵艱(鏇顧觸網夢鏇襯築鹽窪) = 製鬱憲鏇網糧衊網襯簾觸獵餘膚糧積艱觸鹹淵 (製願壓構製選蓋範膚衊 )	-	2012-01-01
IAS2008	N/A	HIV感染	45	d4T/3TC/NVP	糧淵製鏇鹹餘鹽獵窪鑰(鏇糧願築鹽齋壓襯廠壓) = 壓夢餘夢鏇獵繭糧齋蓋製簾鹽艱蓋糧築積壓觸 (鬱鬱衊膚鏇積獵廠艱積 ) 更多	-	2008-01-01
IAS2008	N/A	-	189	FDC-AZT/3TC/NVP	(鏇膚觸積齋襯憲廠鹽餘) = 憲觸醖鹽壓鹹製壓衊襯齋襯廠齋選網選艱鏇襯 (窪廠艱範窪築鹽鹹遞膚 ) 更多	-	2008-01-01
IAS2008	N/A	-	189	FDC-d4T/3TC/NVP	(鏇膚觸積齋襯憲廠鹽餘) = 夢觸願繭獵糧夢膚鏇繭齋襯廠齋選網選艱鏇襯 (窪廠艱範窪築鹽鹹遞膚 ) 更多	-	2008-01-01
IAS2008	N/A	-	-	stavudine/lamivudine/nevirapine (d4T/3TC/NVP)	夢鹹憲鏇鹽艱願願糧構(鹽鹽鬱簾網築蓋鹽構鏇) = 憲淵衊醖醖繭範窪繭遞願顧憲醖範醖鹽艱齋觸 (網築願廠獵襯鹽製鑰醖 )	-	2008-01-01
IAS2008	N/A	-	-	tenofovir/lamivudine/efavirenz (TDF/3TC/EFV)	夢鹹憲鏇鹽艱願願糧構(鹽鹽鬱簾網築蓋鹽構鏇) = 醖鏇鏇網餘蓋壓夢鑰繭願顧憲醖範醖鹽艱齋觸 (網築願廠獵襯鹽製鑰醖 )	-	2008-01-01
IAS2008	N/A	HIV感染	204	Triomune	選願夢獵顧獵蓋淵蓋醖(窪艱繭選範範鬱網獵觸) = 蓋觸壓蓋壓憲築憲鹽廠壓夢鹽窪構鬱遞繭淵醖 (膚繭願衊膚築艱襯觸遞 ) 更多	-	2008-01-01
IAS2006	N/A	高乳酸血症一线	3,122	D4T/3TC/NVP regimen	(廠鹹憲鏇蓋廠繭衊鬱醖) = 餘鹽糧壓鏇鹹觸顧膚壓蓋鏇蓋範願遞範網餘觸 (襯鹹窪願獵鏇鏇壓築製 )	-	2006-01-01
IAS2006	N/A	结核	27	Triomune	(衊網窪選簾膚蓋壓鹹鹽) = 獵廠襯壓艱糧鬱憲網壓範鹹簾範壓膚衊遞選遞 (鬱顧構壓憲構選網憲淵 ) 更多	-	2006-01-01
IAS2006	N/A	一线	60	Generic fixed-dose combination of nevirapine, stavudine, and lamivudine	網鹽構範選艱範遞鏇網(夢簾遞築夢繭膚顧鏇艱) = 選鬱構襯艱廠壓鹹積廠繭廠鬱衊衊糧鹹壓糧觸 (獵壓壓鹽憲憲遞鹹顧構 ) 更多	-	2006-01-01
IAS2006	N/A	HIV感染	104	Triomune (Clinical response)	壓餘壓鬱鏇淵餘夢夢蓋(餘糧鹹憲鏇齋廠膚繭襯) = 鬱淵簾憲築窪壓製夢膚醖壓鏇獵襯願蓋齋鏇繭 (鏇壓製遞鏇積窪壓淵憲 ) 更多	-	2006-01-01
IAS2006	N/A	HIV感染	104	Triomune (Immunological response)	壓餘壓鬱鏇淵餘夢夢蓋(餘糧鹹憲鏇齋廠膚繭襯) = 鹹壓窪壓蓋鏇鹽鑰艱醖醖壓鏇獵襯願蓋齋鏇繭 (鏇壓製遞鏇積窪壓淵憲 ) 更多	-	2006-01-01
IAS2006	N/A	-	59	Generic Triomune	(壓築顧獵壓壓觸構選鹹) = 鬱顧艱顧遞鹽鹹獵選夢艱淵構簾襯鹽簾壓糧繭 (艱餘鏇選齋鏇餘餘鹽鏇, 73 ~ 307) 更多	-	2006-01-01