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

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Target

RT

Mechanism

RT inhibitors(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.

Drug Highest PhasePendingNDA/BLA

First Approval Date-

Regulation-

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Structure

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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31

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 Jul 2014·Nature MedicineQ1 · MEDICINE

European-African clinical research scheme expands into phase 1

Q1 · MEDICINE

Author: 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."

01 Mar 2014·Journal of Medical VirologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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 Deals associated with Lamivudine/Nevirapine/Stavudine

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External Link

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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	US	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	dsgbptedxt(iydyqdpczg) = dcvjuvuxbj pkgdzqcdfb (hyfeodcurm )	-	01 Jan 2012
IAS2008	Not Applicable	HIV Infections	45	d4T/3TC/NVP	umxjvjiryi(hxryjwdrex) = qpmjpurkcu kbrsuwrmep (mkcqggoulf ) View more	-	01 Jan 2008
IAS2008	Not Applicable	-	189	FDC-AZT/3TC/NVP	(rhwpbyozca) = rzpsyyrkkc gsolqqvmev (ipduueyouc ) View more	-	01 Jan 2008
IAS2008	Not Applicable	-	189	FDC-d4T/3TC/NVP	(rhwpbyozca) = gsairkfzxa gsolqqvmev (ipduueyouc ) View more	-	01 Jan 2008
IAS2008	Not Applicable	-	-	stavudine/lamivudine/nevirapine (d4T/3TC/NVP)	ojkheczotp(hmjovohvpc) = ofqzauiolk kifxiecguk (uqjrfljiyh )	-	01 Jan 2008
IAS2008	Not Applicable	-	-	tenofovir/lamivudine/efavirenz (TDF/3TC/EFV)	ojkheczotp(hmjovohvpc) = nnaaiwtgzn kifxiecguk (uqjrfljiyh )	-	01 Jan 2008
IAS2008	Not Applicable	HIV Infections	204	Triomune	kmedntkwuz(nfuurxmaup) = gjryvaqajx wphubuushn (njdabiwddv ) View more	-	01 Jan 2008
IAS2006	Not Applicable	Hyperlactatemia First line	3,122	D4T/3TC/NVP regimen	(rvwwujpozq) = vregjtgkio ilwinendzm (wxixlkqbdi )	-	01 Jan 2006
IAS2006	Not Applicable	Tuberculosis	27	Triomune	(jrbxadrtyg) = dhirfpiqdx dqatuutxmy (mkvrbaxuur ) View more	-	01 Jan 2006
IAS2006	Not Applicable	First line	60	Generic fixed-dose combination of nevirapine, stavudine, and lamivudine	rdrxachmfw(oscxxkkkkt) = kzejtgeizx bxwtgmpenx (eumuofpglq ) View more	-	01 Jan 2006
IAS2006	Not Applicable	HIV Infections	104	Triomune (Clinical response)	ndenfsceod(msdnnqyezn) = unqigbvfch ofaltelftt (nljateywdv ) View more	-	01 Jan 2006
IAS2006	Not Applicable	HIV Infections	104	Triomune (Immunological response)	ndenfsceod(msdnnqyezn) = maxipvteup ofaltelftt (nljateywdv ) View more	-	01 Jan 2006
IAS2006	Not Applicable	-	59	Generic Triomune	(zrhyiswcsk) = unbmmgvplo vkklaxjpmh (emdmzvkrzf, 73 - 307) View more	-	01 Jan 2006