Simultaneous quantification of Lamivudine and Zidovudine in tablets by HPTLC method was developed and validated.The chromatograms were developed using a mobile phase of toluene:ethyl acetate:methanol (4:4:2,v/v/v) on ...Simultaneous quantification of Lamivudine and Zidovudine in tablets by HPTLC method was developed and validated.The chromatograms were developed using a mobile phase of toluene:ethyl acetate:methanol (4:4:2,v/v/v) on pre-coated plate of silica gel GF aluminum TLC plate and quantified by densitometric absorbance mode at 276 nm.The R f values were 0.4170.03 and 0.6070.04 for Lamivudine and Zidovudine,respectively.The linearity of the method was found to be within the concentration range of 50 250 ng/spot for Lamivudine and for Zidovudine,it was 100 500 ng/spot.The lower limits of detection and quantification were 2.23 ng/spot and 7.90 ng/spot for Lamivudine and 2.90 ng/spot and 8.85 ng/spot for Zidovudine.The method was also validated for precision,specificity and recovery.This developed method was used to analyze fixed-dose tablets (Duovir,Cipla Ltd) samples of Lamivudine and Zidovudine.展开更多
Objective: The purpose of this study was to investigate whether switching HIV-infected patients stabilized on Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) plus lopinavir/ritonavir 400 mg/100mg twice ...Objective: The purpose of this study was to investigate whether switching HIV-infected patients stabilized on Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) plus lopinavir/ritonavir 400 mg/100mg twice daily to Trizivir alone affects clinical efficacy and tolerability. Methods: This phase 4, open-label, pilot study was conducted over 96 weeks in 23 antiretroviral-na?ve, HIV-infected patients. Initially, these patients received induction therapy with Trizivir plus lopinavir/ritonavir 400 mg/100mg twice daily. Patients who achieved a viral load 3. Nineteen patients completed induction;of the four who did not, three were lost to follow-up and one withdrew due to gastrointestinal adverse events. In 14 induction completers who had viral load measurements taken at week 48, intent-to-treat: observed analysis showed a week 48 viral load 3 higher than the baseline count. Twelve patients completed the subsequent 48-week Trizivir-alone maintenance phase, of whom 11 (92%) achieved viral loads of both 3 above baseline. Trizivir-only maintenance was associated with fewer adverse events than the Trizivir-lopinavir/ritonavir induction phase and with improvement in total cholesterol, LDL-cholesterol, and triglycerides. Conclusions: Trizivir-alone maintenance after Trizivir-lopinavir/ritonavir induction maintained virologic and CD4+ cell response, and was associated with an improved adverse event and lipid profile.展开更多
A rapid and sensitive LC-MS/MS method for the simultaneous quantitation of lamivudine,zidovudine and nevirapine in human plasma using abacavir as internal standard has been developed and validated.The analytes and IS ...A rapid and sensitive LC-MS/MS method for the simultaneous quantitation of lamivudine,zidovudine and nevirapine in human plasma using abacavir as internal standard has been developed and validated.The analytes and IS were extracted from plasma by solid phase extraction using Oasis HLB cartridges and separated on a Hypurity Advance C18 column using a mixture of acetonitrile:0.1% formic acid(76:24,v/v)at a flow rate of 0.8 mL/min.Detection involved an API-4000 LC MS/MS with electrospray ionization in the positive ion mode and multiple-reaction monitoring for analysis.The method was validated according to FDA guidelines and shown to provide intra-and inter-day precision and accuracy within acceptable limits in a run time of only 3.5 min.The method was sucessfully applied to a pharmacokinetic study involving a single oral administration of a combination tablet to human male volunteers.展开更多
目的系统评价齐多夫定(zidovudine,ZDV)与拉米夫定(lamivudine,3TC)联用阻断HIV母婴传播的有效性和安全性。方法计算机检索Cochrane图书馆(2007第2期)、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo...目的系统评价齐多夫定(zidovudine,ZDV)与拉米夫定(lamivudine,3TC)联用阻断HIV母婴传播的有效性和安全性。方法计算机检索Cochrane图书馆(2007第2期)、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo、CRD(center of review and dissemination)、CBMdisc,VIP和CNKI等数据库,以及全球或地区性AIDS相关的会议论文集、政府或非政府组织的相关文件等,全面收集ZDV+3TC联用预防HIV母婴传播的随机对照试验。检索日期从1980年1月1日到2007年5月31日。由两名评价员独立筛查文献、评价质量和提取资料,然后交叉核对,若遇分歧则征求第三方意见讨论解决。Meta分析采用RevMan软件。结果共纳入4篇全文和7篇摘要,涉及3个RCT。1个大样本RCT(PETRA,1797例)比较了母乳喂养人群ZDV+3TC长疗程(从孕36周到产后1周)、短疗程(产时到产后1周)和超短疗程(仅产时)与安慰剂预防HIV母婴传播的效果,结果显示:在15个月内,长程和短程ZDV+3TC预防效果均优于安慰剂,能降低HIV母婴传播风险的35%～65%;但超短疗程与安慰剂比较,差异无统计学意义。在6周到3月内,长程和短程ZDV+3TC均优于超短程,能降低HIV母婴传播风险的41%～63%。各组死产、婴儿6周和18个月内死亡、出生缺陷和不良反应发生率均相似(P>0.05)。1个大样本RCT(SAINT,1317例)比较了短程ZDV+3TC(产时到产后1周)与奈韦拉平(NVP,母婴均单剂)预防HIV母婴传播的效果,结果显示:两组婴儿8周时HIV感染率和死产率、母婴死亡率、母婴不良反应发生率差异均无统计学意义(P>0.05)。1个小样本RCT(Moodley,20例)显示:3TC单用和ZDV+3TC联用(均从孕38周开始治疗至产后1周),在产后1～2周两组婴儿均无HIV感染,12个月时仅1例感染,且两组药物耐受性均较好。结论与安慰剂比较,在母乳喂养人群中长程(孕36周至产后1周)和短程(产时至产后1周)ZDV+3TC预防HIV母婴传播更有效,而且安全性相似。短程ZDV+3TC预防效果和安全性与母婴单剂NVP相似。长程ZDV+3TC预防效果与3TC相似。展开更多
文摘Simultaneous quantification of Lamivudine and Zidovudine in tablets by HPTLC method was developed and validated.The chromatograms were developed using a mobile phase of toluene:ethyl acetate:methanol (4:4:2,v/v/v) on pre-coated plate of silica gel GF aluminum TLC plate and quantified by densitometric absorbance mode at 276 nm.The R f values were 0.4170.03 and 0.6070.04 for Lamivudine and Zidovudine,respectively.The linearity of the method was found to be within the concentration range of 50 250 ng/spot for Lamivudine and for Zidovudine,it was 100 500 ng/spot.The lower limits of detection and quantification were 2.23 ng/spot and 7.90 ng/spot for Lamivudine and 2.90 ng/spot and 8.85 ng/spot for Zidovudine.The method was also validated for precision,specificity and recovery.This developed method was used to analyze fixed-dose tablets (Duovir,Cipla Ltd) samples of Lamivudine and Zidovudine.
文摘Objective: The purpose of this study was to investigate whether switching HIV-infected patients stabilized on Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) plus lopinavir/ritonavir 400 mg/100mg twice daily to Trizivir alone affects clinical efficacy and tolerability. Methods: This phase 4, open-label, pilot study was conducted over 96 weeks in 23 antiretroviral-na?ve, HIV-infected patients. Initially, these patients received induction therapy with Trizivir plus lopinavir/ritonavir 400 mg/100mg twice daily. Patients who achieved a viral load 3. Nineteen patients completed induction;of the four who did not, three were lost to follow-up and one withdrew due to gastrointestinal adverse events. In 14 induction completers who had viral load measurements taken at week 48, intent-to-treat: observed analysis showed a week 48 viral load 3 higher than the baseline count. Twelve patients completed the subsequent 48-week Trizivir-alone maintenance phase, of whom 11 (92%) achieved viral loads of both 3 above baseline. Trizivir-only maintenance was associated with fewer adverse events than the Trizivir-lopinavir/ritonavir induction phase and with improvement in total cholesterol, LDL-cholesterol, and triglycerides. Conclusions: Trizivir-alone maintenance after Trizivir-lopinavir/ritonavir induction maintained virologic and CD4+ cell response, and was associated with an improved adverse event and lipid profile.
文摘A rapid and sensitive LC-MS/MS method for the simultaneous quantitation of lamivudine,zidovudine and nevirapine in human plasma using abacavir as internal standard has been developed and validated.The analytes and IS were extracted from plasma by solid phase extraction using Oasis HLB cartridges and separated on a Hypurity Advance C18 column using a mixture of acetonitrile:0.1% formic acid(76:24,v/v)at a flow rate of 0.8 mL/min.Detection involved an API-4000 LC MS/MS with electrospray ionization in the positive ion mode and multiple-reaction monitoring for analysis.The method was validated according to FDA guidelines and shown to provide intra-and inter-day precision and accuracy within acceptable limits in a run time of only 3.5 min.The method was sucessfully applied to a pharmacokinetic study involving a single oral administration of a combination tablet to human male volunteers.
文摘目的系统评价齐多夫定(zidovudine,ZDV)与拉米夫定(lamivudine,3TC)联用阻断HIV母婴传播的有效性和安全性。方法计算机检索Cochrane图书馆(2007第2期)、PubMed、EMbase、CINAHL、AIDSearch、AIDSLINE、AIDSTRIALS、AIDSDRUGS、AIDSinfo、CRD(center of review and dissemination)、CBMdisc,VIP和CNKI等数据库,以及全球或地区性AIDS相关的会议论文集、政府或非政府组织的相关文件等,全面收集ZDV+3TC联用预防HIV母婴传播的随机对照试验。检索日期从1980年1月1日到2007年5月31日。由两名评价员独立筛查文献、评价质量和提取资料,然后交叉核对,若遇分歧则征求第三方意见讨论解决。Meta分析采用RevMan软件。结果共纳入4篇全文和7篇摘要,涉及3个RCT。1个大样本RCT(PETRA,1797例)比较了母乳喂养人群ZDV+3TC长疗程(从孕36周到产后1周)、短疗程(产时到产后1周)和超短疗程(仅产时)与安慰剂预防HIV母婴传播的效果,结果显示:在15个月内,长程和短程ZDV+3TC预防效果均优于安慰剂,能降低HIV母婴传播风险的35%～65%;但超短疗程与安慰剂比较,差异无统计学意义。在6周到3月内,长程和短程ZDV+3TC均优于超短程,能降低HIV母婴传播风险的41%～63%。各组死产、婴儿6周和18个月内死亡、出生缺陷和不良反应发生率均相似(P>0.05)。1个大样本RCT(SAINT,1317例)比较了短程ZDV+3TC(产时到产后1周)与奈韦拉平(NVP,母婴均单剂)预防HIV母婴传播的效果,结果显示:两组婴儿8周时HIV感染率和死产率、母婴死亡率、母婴不良反应发生率差异均无统计学意义(P>0.05)。1个小样本RCT(Moodley,20例)显示:3TC单用和ZDV+3TC联用(均从孕38周开始治疗至产后1周),在产后1～2周两组婴儿均无HIV感染,12个月时仅1例感染,且两组药物耐受性均较好。结论与安慰剂比较,在母乳喂养人群中长程(孕36周至产后1周)和短程(产时至产后1周)ZDV+3TC预防HIV母婴传播更有效,而且安全性相似。短程ZDV+3TC预防效果和安全性与母婴单剂NVP相似。长程ZDV+3TC预防效果与3TC相似。
