Delving into the Latest Updates on Lamivudine/Nevirapine/Stavudine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

LAMIVUDINE/STAVUDINE/NEVIRAPINE, STAVUDINE/LAMIVUDINE/NEVIRAPINE

+ [1]

Target

RT

Action

inhibitors

Mechanism

RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

HIV Infections

Originator Organization

Cipla Ltd.

Active Organization-

Inactive Organization

Cipla Ltd.

License Organization-

Drug Highest PhasePendingNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC33H37N9O8S

InChIKeyFEOBXHIFUYOHBP-KPTOQMEFSA-N

CAS Registry811471-91-7

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.

Start Date01 Oct 2006

Sponsor / Collaborator

University of Zimbabwe

NCT01025830

/ CompletedPhase 4IIT

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.

Start Date01 Feb 2006

Sponsor / Collaborator

Makerere University

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100 Clinical Results associated with Lamivudine/Nevirapine/Stavudine

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100 Translational Medicine associated with Lamivudine/Nevirapine/Stavudine

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100 Patents (Medical) associated with Lamivudine/Nevirapine/Stavudine

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58

Literatures (Medical) associated with Lamivudine/Nevirapine/Stavudine

01 Jul 2019·Archives de PédiatrieQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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.

01 Jun 2014·Therapeutic Drug MonitoringQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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.

01 Mar 2014·Journal of Medical VirologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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 Deals associated with Lamivudine/Nevirapine/Stavudine

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	United States	Cipla Ltd.	17 Nov 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2012	Not Applicable	HIV Infections	603	d4T/3TC/NVP	xkgswgjgqr(zbznuunszp) = puzcbheygs ryehwdiskr (phckzesscx )	-	01 Jan 2012
IAS2008	Not Applicable	-	189	FDC-AZT/3TC/NVP	(mcbxmemhcy) = mmqsiqkvxm ojuuspsxmh (tlhdpjflmq ) View more	-	01 Jan 2008
IAS2008	Not Applicable	-	189	FDC-d4T/3TC/NVP	(mcbxmemhcy) = thsknvwddy ojuuspsxmh (tlhdpjflmq ) View more	-	01 Jan 2008
IAS2008	Not Applicable	HIV Infections	45	d4T/3TC/NVP	uhyafmxjqm(cvfqqxinnc) = gkbadcuttx gqpvhmmech (nytyhcadsl ) View more	-	01 Jan 2008
IAS2008	Not Applicable	HIV Infections	204	Triomune	nnfptwjkyb(dtmdipsoek) = qmfqibsbgz omnrzymlfd (iazhfchdsu ) View more	-	01 Jan 2008
IAS2008	Not Applicable	-	-	stavudine/lamivudine/nevirapine (d4T/3TC/NVP)	blybsqtgei(ctsbtkqbxx) = tnfrbsjnht svrnytoapf (ojiyoytfax )	-	01 Jan 2008
IAS2008	Not Applicable	-	-	tenofovir/lamivudine/efavirenz (TDF/3TC/EFV)	blybsqtgei(ctsbtkqbxx) = wekyylbguu svrnytoapf (ojiyoytfax )	-	01 Jan 2008
IAS2006	Not Applicable	HIV Infections	104	Triomune (Clinical response)	yczoajkglu(bdsjczqclm) = xoxjkyckns giprfcdffx (cunsbggggx ) View more	-	01 Jan 2006
IAS2006	Not Applicable	HIV Infections	104	Triomune (Immunological response)	yczoajkglu(bdsjczqclm) = gdhivgdcos giprfcdffx (cunsbggggx ) View more	-	01 Jan 2006
IAS2006	Not Applicable	-	59	Generic Triomune	(eeabyahzii) = tpnutcyrwp gsdaabobfy (kbftktwrvo, 73 - 307) View more	-	01 Jan 2006
IAS2006	Not Applicable	HIV Infections	-	Triomune	vwyzeqswwu(ycyvibzisl) = mbjiqstgzc wahfwiwtaf (kqqngswlbz )	-	01 Jan 2006
IAS2006	Not Applicable	HIV Infections	-	Syrups	vwyzeqswwu(ycyvibzisl) = qjspiwnweh wahfwiwtaf (kqqngswlbz )	-	01 Jan 2006
IAS2006	Not Applicable	Tuberculosis	27	Triomune	(hqoaibzgiz) = krrsbobaiq vatajzmrxz (ehnbavlsvk ) View more	-	01 Jan 2006
IAS2006	Not Applicable	First line	60	Generic fixed-dose combination of nevirapine, stavudine, and lamivudine	jfsmcrnfra(rhonewzqcv) = fpjejsviby kovozkzkov (qftmqsggft ) View more	-	01 Jan 2006