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Raltegravir in childrens

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https://www.readbyqxmd.com/read/27615375/decreased-pd-1-expression-on-cd8-lymphocyte-subsets-and-increase-in-cd8%C3%A2-tscm-cells-in-children-with-hiv-receiving-raltegravir
#1
Florin Tuluc, Sergei Spitsin, Nancy B Tustin, Jennifer B Murray, Richard Tustin, Laura A Schankel, Andrew Wiznia, Sharon Nachman, Steven D Douglas
We investigated the effect of combination antiretroviral therapy (cART) on immune recovery, particularly on the percentages of PD-1-positive cells within the major leukocyte subsets. Cryopreserved peripheral blood mononuclear cells and plasma samples collected longitudinally from a subset of 13 children and adolescents (between 9.7 and 18.2 years old) who were enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1066 were used for this study. Immunophenotyping by flow cytometry was performed to determine the effect of raltegravir-containing cART regimen on the distribution of leukocyte populations, on the expression of PD-1 on T cell subpopulations, and on the expression of well-established markers of T cell activation (CD38 and HLA-DR) on CD8 T cells...
October 18, 2016: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/26999770/genotype-guided-antiretroviral-regimens-in-children-with-multidrug-resistant-hiv-1-infection
#2
Gloria Huerta-García, José G Vazquez-Rosales, José A Mata-Marín, Leoncio Peregrino-Bejarano, Eric Flores-Ruiz, Fortino Solórzano-Santos
BACKGROUND: Genotyping tests were developed to attenuate the impact of viral resistance. Information about the efficacy in genotype base antiretroviral therapy in children is rare and even more in low- and middle-income countries. METHODS: Sixteen children with antiretroviral therapy (ART) failure and triple-class drug-resistant viruses were included in this study. Protease and retrotranscriptase genotypes were available for all patients. Switch of ART regimen was guided by genotyping data...
July 2016: Pediatric Research
https://www.readbyqxmd.com/read/26582887/pharmacokinetics-and-48-week-safety-and-efficacy-of-raltegravir-for-oral-suspension-in-human-immunodeficiency-virus-type-1-infected-children-4-weeks-to-2-years-of-age
#3
Sharon Nachman, Carmelita Alvero, Edward P Acosta, Hedy Teppler, Brenda Homony, Bobbie Graham, Terence Fenton, Xia Xu, Matthew L Rizk, Stephen A Spector, Lisa M Frenkel, Carol Worrell, Edward Handelsman, Andrew Wiznia
BACKGROUND: IMPAACT P1066 is a Phase I/II open-label multicenter trial to evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of multiple raltegravir (RAL) formulations in human immunodeficiency virus (HIV)-infected youth. METHODS: Dose selection of the oral suspension formulation for each cohort (IV: 6 months to <2 years and V: 4 weeks to <6 months) was based on review of short-term safety (4 weeks) and intensive PK evaluation. Safety data through Weeks 24 and 48 and Grade ≥3 or serious adverse events (AEs) were assessed...
December 2015: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/26291460/medicine-patent-pool-pharma-philanthropy-or-pr
#4
EDITORIAL
Carmela De Luca
Merck recently signed an agreement with The Medicines Patent Pool (MPP) to license intellectual property relating to pediatric formulations of its integrase HIV drug, raltegravir (Ral) (the 'Agreement'). The Agreement is alleged to clear the way for cheaper formulations for use in developing and some middle income countries and allows for the development of novel pediatric formulations of Ral as well as novel combinations. Merck's license is royalty free and under the terms of the Agreement, manufacturers anywhere in the world who meet the quality assurance criteria, can manufacture and sell pediatric versions of the drug in the licensed countries under the agreed conditions without paying a royalty to Merck...
2015: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/26242765/use-of-integrase-inhibitors-in-hiv-infected-children-and-adolescents
#5
REVIEW
Walter Dehority, Jacobo Abadi, Andrew Wiznia, Rolando M Viani
Resistance to antiretroviral drugs is an increasingly prevalent challenge affecting both the adult and pediatric HIV-infected populations. Though data on the safety, pharmacokinetics, and efficacy of newer antiretroviral agents in children typically lags behind adult data, newer agents are becoming available for use in HIV-infected children who are failing to respond to or are experiencing toxicities with traditional antiretroviral regimens. Integrase strand transfer inhibitors are one such new class of antiretrovirals...
September 2015: Drugs
https://www.readbyqxmd.com/read/26235538/medicine-patent-pool-pharma-philanthropy-or-pr
#6
Carmela De Luca
Merck recently signed an agreement with The Medicines Patent Pool (MPP) to license intellectual property relating to pediatric formulations of its integrase HIV drug, raltegravir (Ral) (the 'Agreement'). The Agreement is alleged to clear the way for cheaper formulations for use in developing and some middle income countries and allows for the development of novel pediatric formulations of Ral as well as novel combinations. Merck's license is royalty free and under the terms of the Agreement, manufacturers anywhere in the world who meet the quality assurance criteria, can manufacture and sell pediatric versions of the drug in the licensed countries under the agreed conditions without paying a royalty to Merck...
August 3, 2015: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/25944344/raltegravir-in-hiv-1-infected-pregnant-women-pharmacokinetics-safety-and-efficacy
#7
MULTICENTER STUDY
Maren I Blonk, Angela P H Colbers, Carmen Hidalgo-Tenorio, Kabamba Kabeya, Katharina Weizsäcker, Annette E Haberl, José Moltó, David A Hawkins, Marchina E van der Ende, Andrea Gingelmaier, Graham P Taylor, Jelena Ivanovic, Carlo Giaquinto, David M Burger
BACKGROUND: The use of raltegravir in human immunodeficiency virus (HIV)-infected pregnant women is important in the prevention of mother-to-child HIV transmission, especially in circumstances when a rapid decline of HIV RNA load is warranted or when preferred antiretroviral agents cannot be used. Physiological changes during pregnancy can reduce antiretroviral drug exposure. We studied the effect of pregnancy on the pharmacokinetics of raltegravir and its safety and efficacy in HIV-infected pregnant women...
September 1, 2015: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/25850607/comparative-safety-and-neuropsychiatric-adverse-events-associated-with-efavirenz-use-in-first-line-antiretroviral-therapy-a-systematic-review-and-meta-analysis-of-randomized-trials
#8
REVIEW
Nathan Ford, Zara Shubber, Anton Pozniak, Marco Vitoria, Meg Doherty, Catherine Kirby, Alexandra Calmy
INTRODUCTION: Efavirenz (EFV) is widely used for the treatment of antiretroviral-naive HIV-positive individuals, but there are concerns about the risk of adverse neuropsychiatric events. We systematically reviewed the safety of EFV in first-line therapy. METHODS: Four databases were searched until October 2014 for randomized trials comparing EFV against non-EFV-based regimens for the treatment of antiretroviral-naive HIV-positive adults and children. The primary outcome was drug discontinuation as a result of any adverse event...
August 1, 2015: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/25753401/population-pharmacokinetic-analysis-of-raltegravir-pediatric-formulations-in-hiv-infected-children-4-weeks-to-18-years-of-age
#9
COMPARATIVE STUDY
Matthew L Rizk, Lihong Du, Chantelle Bennetto-Hood, Larissa Wenning, Hedy Teppler, Brenda Homony, Bobbie Graham, Carrie Fry, Sharon Nachman, Andrew Wiznia, Carol Worrell, Betsy Smith, Edward P Acosta
P1066 is an open-label study of raltegravir in HIV positive youth, ages 4 weeks-18 years. Here we summarize P1066 pharmacokinetic (PK) data and a population PK model for the pediatric chewable tablet and oral granules. Raltegravir PK parameters were calculated using noncompartmental analysis. A 2-compartment model was developed using data from P1066 and an adult study of the pediatric formulations. Interindividual variability was described by an exponential error model, and residual variability was captured by an additive/proportional error model...
July 2015: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/25325117/raltegravir-in-hiv-infected-in-children-at-least-2-years-of-age-only-after-prior-treatment-failure
#10
(no author information available yet)
The first integrase inhibitor to be approved for children; antiretroviral effect similar to that observed in adults in treatment failure; no first-line evaluation.
September 2014: Prescrire International
https://www.readbyqxmd.com/read/24608069/a-pharmacokinetic-comparison-of-adult-and-paediatric-formulations-of-raltegravir-in-healthy-adults
#11
RANDOMIZED CONTROLLED TRIAL
Elizabeth G Rhee, Matthew L Rizk, Diana M Brainard, Isaias N Gendrano, Bo Jin, Larissa A Wenning, John A Wagner, Marian Iwamoto
BACKGROUND: Raltegravir is an HIV-1 integrase inhibitor approved for use in adults, children and infants ≥4 weeks of age. As alternatives to the original film-coated tablet, a chewable ethylcellulose (EC) tablet and oral granules for suspension (GFS) have been developed for use in children. The purpose of this study was to evaluate these formulations in adults prior to use in paediatric studies. METHODS: This open-label, 4-period, randomized, crossover study investigated the safety, tolerability and pharmacokinetics of raltegravir paediatric formulations and the effect of a high-fat meal on EC tablet pharmacokinetics in healthy adults...
2014: Antiviral Therapy
https://www.readbyqxmd.com/read/24600298/raltegravir-for-hiv-1-infected-children-and-adolescents-efficacy-safety-and-pharmacokinetics
#12
REVIEW
Kajal B Larson, Jennifer R King, Edward P Acosta
Raltegravir was the first HIV integrase strand-transfer inhibitor to be approved by the US FDA, in October 2007, for the treatment of HIV-1 infection in combination with other antiretroviral agents. Raltegravir can be used in treatment-naïve and -experienced patients, as well as for the treatment of multidrug-resistant infection. Raltegravir exists in two formulations: a film-coated tablet administered orally at 400 mg twice daily, and a chewable tablet administered orally at 300 mg twice daily. In 2011, raltegravir was also approved for the treatment of children and adolescents, ages 2-18 years...
2013: Adolescent Health, Medicine and Therapeutics
https://www.readbyqxmd.com/read/24450269/-integrase-inhibitors-new-challenges-for-the-treatment-of-hiv-1-infections
#13
REVIEW
Ingo Stock
Integrase inhibitors are a promising new group of antiretroviral drugs that suppress the integrase yielded by human immunodeficiency viruses (HIV) via inhibiting the ,,integration" of the viral deoxyribonucleic acid (DNA) into the hosts' DNA genome. In 2007, raltegravir was the first integrase inhibitor that has been approved for the treatment of HIV-1 infections in antiretroviral-pretreated (-experienced) and antiretroviral-naive patients. Recently, elvitegravir, as a fixed coformulation with cobicistat, tenofovir und emtricitabine, has been approved for the treatment of HIV-1-infected antiretroviral-naive patients...
December 2013: Medizinische Monatsschrift Für Pharmazeuten
https://www.readbyqxmd.com/read/24277175/raltegravir-a-review-of-its-use-in-the-management-of-hiv-1-infection-in-children-and-adolescents
#14
REVIEW
Caroline M Perry
Raltegravir (ISENTRESS(®)) is an HIV-1 integrase strand transfer inhibitor that is well established as a component of highly active antiretroviral therapy regimens for the treatment of adults with HIV-1 infection, and has recently been approved for the treatment of HIV-1-infected children and adolescents aged 2-18 years. A new chewable formulation has been introduced and results of a pharmacokinetic study have led to the establishment of dosages for this formulation for children. In a phase I/II, open-label, multicentre, clinical trial, raltegravir (administered as the chewable or the film-coated tablet) in combination with optimized background antiretroviral therapy was an effective treatment for treatment-experienced children and adolescents with HIV-1 infection, in terms of virologic measures of efficacy (i...
February 2014: Paediatric Drugs
https://www.readbyqxmd.com/read/24259658/dolutegravir-a-second-generation-integrase-inhibitor-for-the-treatment-of-hiv-1-infection
#15
REVIEW
R Chris Rathbun, Staci M Lockhart, Misty M Miller, Michelle D Liedtke
OBJECTIVE: To review the pharmacology, safety, and efficacy of dolutegravir, an integrase strand-transfer inhibitor (INSTI), and to discuss its role in the treatment of HIV-1-infected patients. DATA SOURCES: PubMed articles indexed through August 2013 were identified using the search terms S/GSK1349572, dolutegravir, and integrase inhibitor. Information was also identified from the package insert, cited publication references, professional meeting abstracts, and the ClinicalTrials...
March 2014: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/24145879/pharmacokinetics-safety-and-48-week-efficacy-of-oral-raltegravir-in-hiv-1-infected-children-aged-2-through-18-years
#16
MULTICENTER STUDY
Sharon Nachman, Nan Zheng, Edward P Acosta, Hedy Teppler, Brenda Homony, Bobbie Graham, Terence Fenton, Xia Xu, Larissa Wenning, Stephen A Spector, Lisa M Frenkel, Carmelita Alvero, Carol Worrell, Edward Handelsman, Andrew Wiznia
BACKGROUND: IMPAACT P1066 is a phase I/II open-label multicenter trial to evaluate pharmacokinetics, safety, tolerability, and efficacy of multiple raltegravir formulations in human immunodeficiency virus (HIV)-infected youth. METHODS: Dose selection for each cohort (I: 12 to <19 years; II: 6 to <12 years; and III: 2 to <6 years) was based on review of short-term safety (4 weeks) and intensive pharmacokinetic evaluation. Safety data through weeks 24 and 48, and grade ≥ 3 or serious adverse events (AEs) were assessed...
February 2014: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/23315674/early-outcomes-of-darunavir-and-or-raltegravir-based-antiretroviral-therapy-in-children-with-multidrug-resistant-hiv-at-a-pediatric-center-in-botswana
#17
Brianna L Kirk, Andres Gomila, Mogomotsi Matshaba, Marape Marape, Dipesalema R Joel, Gabriel Anabwani, Michael A Tolle
BACKGROUND: Data on the use of ritonavir-boosted darunavir (DRV/r) and/or raltegravir (RAL) in resource-limited settings are rare and there is currently no published data regarding their use among African children. Botswana has recently made DRV/r and RAL available for patients failing second-line antiretroviral therapy (ART). METHODS: Retrospective chart review of 4 multidrug-resistant pediatric patients on DRV/r- and/or RAL-based regimens. Viral load, CD4 count, adherence by pill count, and World Health Organization (WHO) clinical stage prior to and after switch to DRV/r- and/or RAL-based regimen were assessed...
March 2013: Journal of the International Association of Providers of AIDS Care
https://www.readbyqxmd.com/read/22330165/potent-and-sustained-antiviral-response-of-raltegravir-based-highly-active-antiretroviral-therapy-in-hiv-type-1-infected-children-and-adolescents
#18
MULTICENTER STUDY
Verónica Briz, Juan A León-Leal, Claudia Palladino, David Moreno-Perez, Santiago J de Ory, Ma Isabel De José, Ma Isabel González-Tomé, César Gavilán Martín, Itziar Pocheville, José T Ramos, Manuel Leal, Ma Ángeles Muñoz-Fernández
BACKGROUND: There are pediatric patients receiving many highly active antiretroviral therapy (HAART) regimens entailing drug resistance mutations that complicate HAART effective therapies. METHODS: This was a multicenter retrospective study of 19 multidrug-resistant children and adolescents enrolled from July 2007 to October 2009. Patients were nonresponders because no reduction in HIV type 1 (HIV-1) RNA to undetectable levels was observed during their previous antiretroviral treatment history...
March 2012: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/22326511/-characteristics-of-human-immunode%C3%AF-ciency-virus-1-infected-children-receiving-highly-active-antiretroviral-therapy-a-cross-sectional-study
#19
K Badillo, L Prieto, M Toledano, S Guillen, A Alvarez, I García Bermejo, J T Ramos Amador
INTRODUCTION: Since 1996, when HAART became available, there has been a change in the course of HIV-infection, leading it to become a chronic disease. Our aim was to describe the characteristics of the children followed up in our hospital. PATIENTS AND METHODS: A cross-sectional study was conducted on 32 HIV-infected children followed up until December-2010, at the University-Hospital de Getafe. Clinical and laboratory information from the last visit was collected for the evaluation of patients...
June 2012: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría (A.E.P.)
https://www.readbyqxmd.com/read/21888444/antiretroviral-therapy-for-children-in-resource-limited-settings-current-regimens-and-the-role-of-newer-agents
#20
REVIEW
Brian S Eley, Tammy Meyers
WHO antiretroviral treatment guidelines for HIV-infected children have influenced the design of treatment programmes in resource-limited settings. This review analyses the latest WHO first- and second-line regimen recommendations. The recommendation to use lopinavir/ritonavir-containing first-line regimens in young children with prior non-nucleoside reverse transcriptase inhibitor (NNRTI) exposure is based on good quality evidence. Recent research suggests that lopinavir/ritonavir-containing first-line regimens should be extended to all young children, irrespective of prior NNRTI exposure...
October 1, 2011: Paediatric Drugs
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