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Hiv and pharmacokinetics

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https://www.readbyqxmd.com/read/28099408/multiphenotype-association-study-of-patients-randomized-to-initiate-antiretroviral-regimens-in-aids-clinical-trials-group-protocol-a5202
#1
Anurag Verma, Yuki Bradford, Shefali S Verma, Sarah A Pendergrass, Eric S Daar, Charles Venuto, Gene D Morse, Marylyn D Ritchie, David W Haas
BACKGROUND: High-throughput approaches are increasingly being used to identify genetic associations across multiple phenotypes simultaneously. Here, we describe a pilot analysis that considered multiple on-treatment laboratory phenotypes from antiretroviral therapy-naive patients who were randomized to initiate antiretroviral regimens in a prospective clinical trial, AIDS Clinical Trials Group protocol A5202. PARTICIPANTS AND METHODS: From among 5 9545 294 polymorphisms imputed genome-wide, we analyzed 2544, including 2124 annotated in the PharmGKB, and 420 previously associated with traits in the GWAS Catalog...
January 5, 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/28092857/universal-efavirenz-determination-in-transport-study-rat-placenta-perfusion-and-placenta-lysate-by-hplc-uv
#2
Lucie Zelena, Josef Reznicek, Martina Ceckova, Hana Sklenarova
Efavirenz is an antiretroviral drug used in the treatment of HIV-positive patients. A simple, fast and sensitive high-performance liquid chromatography (HPLC) method was developed in order to determine efavirenz in three types of samples provided from pharmacokinetic studies. The analysis took 5min and was performed using a C18 analytical column (Discovery HS C18, 150×4.6mm, particle size of 5μm) in isocratic mode with a mobile phase containing acetonitrile and water (65:35, v/v), a flow rate of 1.6mLmin(-1), a sample volume of 10μL and UV detection at 245nm...
January 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28087972/lack-of-effect-of-oral-cabotegravir-on-the-pharmacokinetics-of-a-levonorgestrel-ethinyl-estradiol-containing-oral-contraceptive-in-healthy-adult-females
#3
C Trezza, S L Ford, E Gould, Y Lou, C Huang, J M Ritter, A M Buchanan, W Spreen, P Patel
AIM(S): This study aimed to investigate whether cabotegravir (CAB), an integrase inhibitor in development for treatment and prevention of HIV-1, influences the pharmacokinetics (PK) of a levonorgestrel (LNG) and ethinyl estradiol (EE)-containing oral contraceptive (OC) in healthy women. METHODS: In this open-label, fixed-sequence crossover study, healthy female subjects received LNG 0.15 mg/EE 0.03 mg tablet once daily Days 1-10 alone and with oral CAB 30 mg once daily Days 11-21...
January 14, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28087069/safety-tolerability-and-antiviral-effect-of-rg-101-in-patients-with-chronic-hepatitis-c-a-phase-1b-double-blind-randomised-controlled-trial
#4
Meike H van der Ree, J Marleen de Vree, Femke Stelma, Sophie Willemse, Marc van der Valk, Svend Rietdijk, Richard Molenkamp, Janke Schinkel, Ad C van Nuenen, Ulrich Beuers, Salah Hadi, Marten Harbers, Eva van der Veer, Kai Liu, John Grundy, Amy K Patick, Adam Pavlicek, Jacqueline Blem, Michael Huang, Paul Grint, Steven Neben, Neil W Gibson, Neeltje A Kootstra, Hendrik W Reesink
BACKGROUND: miR-122 is an important host factor for hepatitis C virus (HCV) replication. The aim of this study was to assess the safety and tolerability, pharmacokinetics, and antiviral effect of a single dose of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated oligonucleotide that antagonises miR-122, in patients with chronic HCV infection with various genotypes. METHODS: In this randomised, double-blind, placebo-controlled, multicentre, phase 1B study, patients were randomly assigned to RG-101 or placebo (7:1)...
January 10, 2017: Lancet
https://www.readbyqxmd.com/read/28081342/exploring-cyp2b6-activity-by-measuring-the-presence-ofnevirapine-hydroxy-metabolites-in-plasma
#5
Suzana Mustafa, Norul Badriah Hassan, Soo Choon Tan, Ahmad Kashfi Ab Rahman, Lee Lee Low, Wan Nazirah Wan Yusuf
BACKGROUND/AIM: Nevirapine is a reverse-transcriptase inhibitor widely used in combination therapy to treat HIV infection. Nevirapine is extensively metabolized in the liver and CYP2B6 is mainly responsible for oxidation of 3-hydroxynevirapine (3-OH NVP). This study aims to explore CYP2B6 activity by measuring 2-hydroxynevirapine (2-OH NVP) and 3-OH NVP in plasma and to identify factors associated with nevirapine pharmacokinetic parameters. MATERIALS AND METHODS: A total of 112 patients were recruited and treated with nevirapine-based antiretroviral therapy...
December 20, 2016: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/28079918/dose-evaluation-of-lamivudine-in-hiv-infected-children-aged-5%C3%A2-months-18%C3%A2-years-based-on-a-population-pharmacokinetic-analysis
#6
Esther J H Janssen, Diane E T Bastiaans, Pyry A J Välitalo, Annemarie M C van Rossum, Evelyne Jacqz-Aigrain, Hermione Lyall, Catherijne A J Knibbe, David M Burger
AIM: The objectives of this study were to characterise age-related changes in lamivudine pharmacokinetics in children and evaluate lamivudine exposure, followed by dose recommendations for subgroups in which target steady state AUC0-24h is not reached. METHODS: Population pharmacokinetic modelling was performed in NONMEM using data from two model building datasets and two external datasets (n = 180 (age 0.4-18 years, bodyweight 3.4-60.5 kg); 2,061 samples (median 12 per child); daily oral dose 60-300 mg (3...
January 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28073964/single-dose-pharmacokinetics-and-pharmacodynamics-of-oral-tenofovir-and-emtricitabine-in-blood-saliva-and-rectal-tissue-a-sub-study-of-the-anrs-ipergay-trial
#7
Julien Fonsart, Sentob Saragosti, Milad Taouk, Gilles Peytavin, Lane Bushman, Isabelle Charreau, Allan Hance, Lauriane Goldwirt, Stéphane Morel, Fabrizio Mammano, Bénédicte Loze, Catherine Capitant, François Clavel, Nadia Mahjoub, Laurence Meyer, Peter L Anderson, Constance Delaugerre, Jean-Michel Molina
OBJECTIVES: In the ANRS IPERGAY pre-exposure prophylaxis (PrEP) trial, a single dose of tenofovir disoproxil fumarate and emtricitabine was taken orally 2-24 h before sexual intercourse. A sub-study was conducted to assess the pharmacokinetics of tenofovir and emtricitabine in blood, saliva and rectal tissue following this initial oral intake. METHODS: Plasma, PBMC, saliva and rectal tissue sampling was performed over 24 h in 12 seronegative men before enrolment in the ANRS IPERGAY trial, following a single dose of 600 mg tenofovir disoproxil fumarate/400 mg emtricitabine...
September 28, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28073073/development-and-validation-of-a-liquid-chromatography-ms-ms-method-for-simultaneous-quantification-of-tenofovir-and-efavirenz-in-biological-tissues-and-fluids
#8
Luisa Barreiros, Cassilda Cunha-Reis, Eduarda M P Silva, Joana R B Carvalho, José das Neves, Bruno Sarmento, Marcela A Segundo
Millions of people worldwide live with human immunodeficiency virus (HIV) infection thus justifying the continuous search for new prevention and treatment strategies, including topical microbicide products combining antiretroviral drugs (ARVs) such as tenofovir (TFV) and efavirenz (EFV). Therefore, the aim of this work was to develop and validate a high performance liquid chromatography method coupled to triple quadrupole-tandem mass spectrometry (HPLC-MS/MS) for the quantification of TFV and EFV in biological matrices (mouse vaginal tissue, vaginal lavage and blood plasma)...
December 27, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28065890/impact-of-obesity-on-antiretroviral-pharmacokinetics-and-immuno-virological-response-in-hiv-infected-patients-a-case-control-study
#9
Vincent Madelain, Minh P Le, Karen Champenois, Charlotte Charpentier, Roland Landman, Veronique Joly, Patrick Yeni, Diane Descamps, Yazdan Yazdanpanah, Gilles Peytavin
BACKGROUND: Obesity has high prevalence among HIV-infected patients. Increased adipose tissue mass affects the pharmacokinetics of numerous drugs, but few data are available for antiretroviral drugs. OBJECTIVES: In this study we aimed to explore the pharmacokinetics of antiretroviral drugs and the immuno-virological response in obese patients with HIV infection. PATIENTS AND METHODS: We examined data from 2009 to 2012 in our hospital's database for HIV-1-infected patients who received an antiretroviral drug (abacavir, emtricitabine, lamivudine, tenofovir, efavirenz, etravirine, nevirapine, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir or raltegravir)...
January 8, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28064418/novel-antiretroviral-drugs-in-patients-with-renal-impairment-clinical-and-pharmacokinetic-considerations
#10
Dario Cattaneo, Cristina Gervasoni
Highly active antiretroviral therapy (HAART) has dramatically increased the survival of HIV-infected patients from Western countries reducing the incidence of opportunistic infections and AIDS-related malignancies, and improving the patients' quality of life compared with the pre-HAART era. HIV is thus now considered in the West as a chronic disease, with the majority of HIV-infected patients successfully reaching an optimal immune and virological outcome a few months after starting HAART. However, this switch from acute to chronic disease has been accompanied by an increased incidence of chronic kidney disease (CKD), reported in up to 60% of HIV-infected patients...
January 7, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28060011/topical-tenofovir-protects-against-vaginal-shiv-infection-in-macaques-co-infected-with-chlamydia-trachomatis-and-trichomonas-vaginalis
#11
Natalia Makarova, Tara Henning, Andrew Taylor, Chuong Dinh, Jonathan Lipscomb, Rachael Aubert, Debra Hanson, Christi Phillips, John Papp, James Mitchell, Janet Mcnicholl, Gerardo J Garcia-Lerma, Walid Heneine, Ellen Kersh, Charles Dobard
BACKGROUND: Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV), two prevalent sexual transmitted infections, are known to increase HIV risk in women and could potentially diminish pre-exposure prophylaxis (PrEP) efficacy, particularly for topical interventions that rely on local protection. We investigated in macaques whether co-infection with CT/TV reduces protection by vaginal TFV gel. METHODS: Vaginal TFV gel dosing previously shown to provide 100% or 74% protection when applied either 30 minutes or 3 days before SHIV challenge was assessed in pigtailed macaques co-infected with CT/TV and challenged twice-weekly with SHIV162p3 for up to 10 weeks (2 menstrual cycles)...
January 4, 2017: AIDS
https://www.readbyqxmd.com/read/28051809/pregnancy-related-changes-of-antiretroviral-pharmacokinetics-an-argument-for-tdm
#12
Francesco R Simonetti, Dario Cattaneo, Nadia Zanchetta, Vania Giacomet, Valeria Micheli, Nadia Ciminera, Cristina Gervasoni
Here we describe a case of an HIV-infected young woman with extensive drug-resistant virus, who was successfully switched from a raltegravir-based regimen to a dolutegravir-based intensified antiretroviral regimen a few days before scheduled caesarean section because of the still detectable viral load. The trough concentrations of all antiretroviral drugs before and after delivery are also described.Our case underlines both the difficult management of young women, HIV-infected at young age with very limited treatment options and the great variability in the pregnancy-related physiologic changes affecting the pharmacokinetics of antiretrovirals...
January 4, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28043170/impact-of-disease-drug-and-patient-adherence-on-the-effectiveness-of-antiviral-therapy-in-pediatric-hiv
#13
Chiara Piana, Meindert Danhof, Oscar Della Pasqua
Maintaining effective antiretroviral treatment for life is a major problem, in both resource-limited and resource-rich countries. Despite the progress observed in paediatric antiretroviral therapy, approximately 12% of children still experience treatment failure due to drug resistance, inadequate dosing and poor adherence. We explore the current status of antiretroviral therapy in children with focus on the interaction between disease, drug pharmacokinetics and patient behavior, all of which are strongly interconnected and determine treatment outcome...
January 3, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28042101/efavirenz-dissolution-enhancement-iii-colloid-milling-pharmacokinetics-and-electronic-tongue-evaluation
#14
Cristiane R D Hoffmeister, Cinira Fandaruff, Maíra A da Costa, Lucio M Cabral, Luciana R Pitta, Stanley E R Bilatto, Livia D Prado, Daniel S Corrêa, Leandro Tasso, Marcos Antônio S Silva, Helvécio V A Rocha
Efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), is part of first-line therapy for the treatment of human immunodeficiency virus type 1 infection (HIV-1/AIDS). This drug shows relatively low oral absorption and bioavailability, as well as high intra- and inter-subject variability. Several studies have shown that treatment failure and adverse effects are associated with low and high EFV plasma concentrations, respectively. Some studies suggest different EFV formulations to minimize inter-patient variability and improve its solubility and dissolution; however, all of these formulations are complex, using for instance, cyclodextrins, dendrimers and polymeric nanoparticles, rendering them inviable industrially...
December 29, 2016: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28038962/confirming-model-predicted-pharmacokinetic-interactions-between-bedaquiline-and-lopinavir-ritonavir-or-nevirapine-in-patients-with-hiv-and-drug-resistant-tuberculosis
#15
Margreke J E Brill, Elin M Svensson, Mishal Pandie, Gary Maartens, Mats O Karlsson
Bedaquiline and its metabolite M2 are metabolised by CYP3A4. The antiretrovirals ritonavir-boosted lopinavir (LPV/r) and nevirapine inhibit and induce CYP3A4, respectively. Here we aimed to quantify nevirapine and LPV/r drug-drug interaction effects on bedaquiline and M2 in patients co-infected with HIV and multidrug-resistant tuberculosis (MDR-TB) using population pharmacokinetic (PK) analysis and compare these with model-based predictions from single-dose studies in subjects without TB. An observational PK study was performed in three groups of MDR-TB patients during bedaquiline maintenance dosing: HIV-seronegative patients (n = 17); and HIV-infected patients using antiretroviral therapy including nevirapine (n = 17) or LPV/r (n = 14)...
December 14, 2016: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28032946/population-pharmacokinetics-modeling-of-unbound-efavirenz-atazanavir-and-ritonavir-in-hiv-infected-subjects-with-aging-biomarkers
#16
J B Dumond, J Chen, M Cottrell, C R Trezza, Hma Prince, C Sykes, C Torrice, N White, S Malone, R Wang, K B Patterson, N E Sharpless, A Forrest
Unbound drug is the pharmacodynamically relevant concentration. This study aimed to determine if chronologic age or markers of biologic aging, such as the frailty phenotype and p16(INK4a) gene expression, altered unbound pharmacokinetics (PKs) of efavirenz (EFV) and atazanavir/ritonavir (ATV/RTV). Sixty human immunodeficiency virus (HIV)-infected participants receiving EFV and 31 receiving ATV/RTV provided 1 to 11 samples to quantify total and unbound plasma concentrations. Population PK models with total and unbound concentrations simultaneously described are developed for each drug...
December 29, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28028768/meal-effects-confound-attempts-to-counteract-rabeprazole-induced-hypochlorhydria-decreases-in-atazanavir-absorption
#17
Kathleen Panter Faber, Hsin-Fang Wu, Marc R Yago, Xiaohui Xu, Pathanjali Kadiyala, Lynda A Frassetto, Leslie Z Benet
PURPOSE: Clinically relevant pharmacokinetic interactions exist between gastric acid-reducing agents and certain weakly basic drugs that rely on acidic environments for optimal oral absorption. In this study, we examine whether the administration of betaine hydrochloride under fed conditions can enhance the absorption of atazanavir, an HIV-1 protease inhibitor, during pharmacologically-induced hypochlorhydria. METHODS: In this randomized, single-dose, 3 period, crossover study healthy volunteers received ritonavir-boosted atazanavir (atazanavir/ritonavir 300/100 mg) alone, following pretreatment with the proton pump inhibitor rabeprazole (20 mg twice daily), and with 1500 mg of betaine HCl after rabeprazole pretreatment...
December 27, 2016: Pharmaceutical Research
https://www.readbyqxmd.com/read/28026013/moderate-hepatic-impairment-does-not-affect-doravirine-pharmacokinetics
#18
Sauzanne Khalilieh, Ka Lai Yee, Rachael Liu, Li Fan, Rosa I Sanchez, Patrice Auger, Ilias Triantafyllou, Daria Stypinski, Kenneth C Lasseter, Thomas Marbury, Marian Iwamoto
Doravirine is a novel, potent, nonnucleoside reverse-transcriptase inhibitor currently in development for HIV-1 infection treatment. As a substrate for CYP3A-mediated metabolism, doravirine could potentially be affected by liver-function changes. As a portion of the HIV-1-infected population has varying degrees of liver impairment, we investigated the effect of moderate hepatic impairment on the pharmacokinetic profile and tolerability of single-dose doravirine 100 mg in otherwise healthy subjects. A total of 16 subjects aged 44-64 years took part in the open-label, single-dose trial: 8 with moderate hepatic impairment (Child-Pugh score, 7-9; 6 men, 2 women) and 8 healthy individuals (mean age and height matched with the impairment group; 6 men, 2 women)...
December 27, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28019088/p16-ink4a-a-senescence-marker-influences-tenofovir-emtricitabine-metabolite-disposition-in-hiv-infected-subjects
#19
J B Dumond, J W Collins, M L Cottrell, C R Trezza, Hma Prince, C Sykes, C Torrice, N White, S Malone, R Wang, K B Patterson, N E Sharpless, A Forrest
The goal of this study was to explore the relationships between tenofovir (TFV) and emtricitabine (FTC) disposition and markers of biologic aging, such as the frailty phenotype and p16(INK4a) gene expression. Chronologic age is often explored in population pharmacokinetic (PK) analyses, and can be uninformative in capturing the impact of aging on physiology, particularly in human immunodeficiency virus (HIV)-infected patients. Ninety-one HIV-infected participants provided samples to quantify plasma concentrations of TFV/FTC, as well as peripheral blood mononuclear cell (PBMC) samples for intracellular metabolite concentrations; 12 participants provided 11 samples, and 79 participants provided 4 samples, over a dosing interval...
December 26, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28018925/parasite-clearance-and-artemether-pharmacokinetics-parameters-over-the-course-of-artemether-lumefantrine-treatment-for-malaria-in-human-immunodeficiency-virus-hiv-infected-and-hiv-uninfected-ugandan-children
#20
Richard Kajubi, Liusheng Huang, Moses Were, Sylvia Kiconco, Fangyong Li, Florence Marzan, David Gingrich, Myaing M Nyunt, Joshua Ssebuliba, Norah Mwebaza, Francesca T Aweeka, Sunil Parikh
BACKGROUND: Artemisinins are primarily responsible for initial parasite clearance. Antimalarial pharmacokinetics (PK), human immunodeficiency virus (HIV) infection, and antiretroviral therapy have been shown to impact treatment outcomes, although their impact on early parasite clearance in children has not been well characterized. METHODS: Parasite clearance parameters were generated from twice-daily blood smears in HIV-infected and HIV-uninfected Ugandan children treated with artemether-lumefantrine (AL)...
October 2016: Open Forum Infectious Diseases
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