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Hiv and pharmacokinetics

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https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#1
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135651/comparison-of-the-pharmacokinetics-and-pharmacodynamics-of-single-dose-tenofovir-vaginal-film-and-gel-formulation-fame-05
#2
Jennifer A Robinson, Mark A Marzinke, Edward J Fuchs, Rahul P Bakshi, Hans M L Spiegel, Jenell S Coleman, Lisa C Rohan, Craig W Hendrix
OBJECTIVE: While pre-exposure prophylaxis with oral tenofovir (TFV) disoproxil fumarate/emtricitabine reduces HIV acquisition rates, poor adherence to and acceptability of daily vaginal gels has led to development of vaginal film formulations to improve adherence and, potentially, enable episodic use. STUDY DESIGN: In this two-arm, cross-over study of a fast-dissolving tenofovir film (40 mg) compared to a previously studied semisolid tenofovir 1% gel (40 mg), 10 healthy women received a single vaginal dose of each study product...
November 7, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29135584/concomitant-medication-polypharmacy-interactions-and-imperfect-adherence-are-common-in-australian-adults-on-suppressive-art
#3
Krista J Siefried, Limin Mao, Lucette A Cysique, John Rule, Michelle L Giles, Don E Smith, James Mcmahon, Tim R Read, Catriona Ooi, Ban K Tee, Mark Bloch, John de Wit, Andrew Carr
OBJECTIVES: We quantified concomitant medication (CM) polypharmacy, pharmacokinetic (PK) and pharmacodynamic (PD) interactions, adverse effects and adherence in Australian adults on effective ART. DESIGN: Cross-sectional. METHODS: Patients recruited into a nation-wide cohort and assessed for prevalence and type of CM (including polypharmacy, defined as ≥5 CMs), PK or PD interactions, potential CM adverse effects and CM adherence. Factors associated with CM polypharmacy and with imperfect adherence were identified using multivariable logistic regression...
November 10, 2017: AIDS
https://www.readbyqxmd.com/read/29133560/levofloxacin-population-pharmacokinetics-in-south-african-children-treated-for-multidrug-resistant-tuberculosis
#4
Paolo Denti, Anthony J Garcia-Prats, Heather R Draper, Lubbe Wiesner, Jana Winckler, Stephanie Thee, Kelly E Dooley, Rada M Savic, Helen M McIlleron, H Simon Schaaf, Anneke C Hesseling
Background: Levofloxacin is increasingly used in the treatment of multidrug-resistant tuberculosis (MDR-TB). There are limited paediatric pharmacokinetic data to inform dose selection for children.Methods: Children routinely receiving levofloxacin (250 mg adult tablets) for MDR-TB prophylaxis or disease in Cape Town, South Africa, underwent pharmacokinetic sampling following a 15 or 20 mg/kg dose, given as whole tablet(s) or crushed, orally, or by nasogastric tube. Pharmacokinetic parameters were estimated using non-linear mixed effects modelling...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29133558/pharmacokinetics-and-drug-drug-interactions-of-lopinavir-ritonavir-administered-with-first-and-second-line-antituberculosis-drugs-in-hiv-infected-children-treated-for-multidrug-resistant-tuberculosis
#5
Louvina E van der Laan, Anthony J Garcia-Prats, H Simon Schaaf, Tjokosela Tikiso, Lubbe Wiesner, Mine de Kock, Jana Winckler, Jennifer Norman, Helen McIlleron, Paolo Denti, Anneke C Hesseling
Background Lopinavir/ritonavir forms the backbone of current first-line antiretroviral regimens in young HIV-infected children. As multidrug-resistant (MDR) tuberculosis (TB) frequently occurs in young children in high-burden TB settings, it is important to identify potential interactions between MDR-TB treatment and lopinavir/ritonavir. We describe the pharmacokinetics of and potential drug-drug interactions between lopinavir/ritonavir and routine drugs used for MDR-TB treatment in HIV-infected children.Methods A combined population pharmacokinetic model was developed to jointly describe the pharmacokinetics of lopinavir and ritonavir in 32 HIV-infected children (16 on MDR-TB treatment with combinations of high-dose isoniazid, pyrazinamide, ethambutol, ethionamide, terizidone, a fluoroquinolone, and amikacin: and 16 without TB), who were established on a lopinavir/ritonavir-containing antiretroviral regimen...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29113503/effects-of-crystalline-state-and-self-nanoemulsifying-drug-delivery-system-snedds-on-oral-bioavailability-of-the-novel-anti-hiv-compound-6-benzyl-1-benzyloxymethyl-5-iodouracil-in-rats
#6
Ying-Yuan Lu, Wen-Bing Dai, Xin Wang, Xiao-Wei Wang, Jun-Yi Liu, Pu Li, Ya-Qing Lou, Chuang Lu, Qiang Zhang, Guo-Liang Zhang
The objective of this study was to investigate the effect of crystalline state and a formulation of self-nanoemulsifying drug delivery system (SNEDDS) on oral bioavailability of 6-benzyl-1-benzyloxymethyl-5-iodouracil (W-1), a novel non-nucleoside reverse transcriptase inhibitor, in rats. The crystalline states of W-1 were characterized by scanning electron microscope (SEM), differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD). The SNEDDS was formulated by medium-chain lipids, characterized by droplet particle size...
November 8, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29112064/placental-transfer-of-elvitegravir-and-cobicistat-in-an-ex-vivo-human-cotyledon-double-perfusion-model
#7
Valentine Faure Bardon, Laurent Mandelbrot, Dominique Duro, Chloé Dussaux, Minh Le, Gilles Peytavin
OBJECTIVE: To determine the transplacental pharmacokinetics of the HIV integrase strand transfer inhibitor elvitegravir and of cobicistat, a cytochrome P450 inhibitor used as a pharmacoenhancer in antiretroviral therapy. DESIGN AND METHODS: Maternal-to-fetal transfer across the term human placenta was investigated with the ex-vivo dually perfused cotyledon model, in 7 open-circuit experiments and 10 closed-circuit (recirculating) experiments. Elvitegravir and cobicistat were added to a maternal perfusate containing 2 g/L of human serum albumin and antipyrine, as a marker to validate the cotyledon's viability...
November 2, 2017: AIDS
https://www.readbyqxmd.com/read/29105160/strength-in-amalgamation-newer-combination-agents-for-hiv-and-implications-for-practice
#8
Christopher McCoy, Melissa Badowski, Elizabeth Sherman, Rustin Crutchley, Ethan Smith, Daniel B Chastain
Antiretroviral (ART) therapy for treatment of human immunodeficiency virus (HIV) infection has undergone significant changes over the past 30 years. Many single tablet regimens (STR), including newer fixed dose combination (FDC) tablets, are available, offering patients several options for choosing a treatment regimen that works best for them. Given these changes, patients are more likely to adhere to treatment, achieve better clinical outcomes, and experience both fewer side effects and drug-drug interactions...
November 3, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/29103079/effectiveness-of-kidney-transplantation-in-hiv-infected-recipients-under-combination-antiretroviral-therapy-a-single-cohort-experience-brescia-northern-italy
#9
Ilaria Izzo, Salvatore Casari, Nicola Bossini, Maria Antonia Forleo, Silvio Sandrini, Emanuele Focà, Nigritella Brianese, Giulia Zambolin, Claudia Chirico, Giovanni Cancarini, Francesco Castelli
PURPOSE: Kidney transplantation was recently introduced for the treatment of end stage renal disease (ESRD) in HIV-infected patients. We report the results of the first 28 procedures at our centre. METHODS: A retrospective study was conducted on HIV-infected patients evaluated for kidney transplantation between January 2005 and October 2016. Patients were selected and monitored by the kidney transplantation and infectious diseases teams, according to the national protocol...
November 4, 2017: Infection
https://www.readbyqxmd.com/read/29100346/inhibition-of-hiv-1-infection-in-humanized-mice-and-metabolic-stability-of-protein-phosphatase-1-targeting-small-molecule-1e7-03
#10
Xionghao Lin, Namita Kumari, Catherine DeMarino, Yasemin Saygideğer Kont, Tatiana Ammosova, Amol Kulkarni, Marina Jerebtsova, Guelaguetza Vazquez-Meves, Andrey Ivanov, Kovalskyy Dmytro, Aykut Üren, Fatah Kashanchi, Sergei Nekhai
We recently identified the protein phosphatase-1 - targeting compound, 1E7-03 which inhibited HIV-1 in vitro. Here, we investigated the effect of 1E7-03 on HIV-1 infection in vivo by analyzing its metabolic stability and antiviral activity of 1E7-03 and its metabolites in HIV-1 infected NSG-humanized mice. 1E7-03 was degraded in serum and formed two major degradation products, DP1 and DP3, which bound protein phosphatase-1 in vitro. However, their anti-viral activities were significantly reduced due to inefficient cell permeability...
September 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/29096670/hiv-treatment-simplification-to-elvitegravir-cobicistat-emtricitabine-tenofovir-disproxil-fumarate-e-c-f-tdf-plus-darunavir-a-pharmacokinetic-study
#11
Marianne Harris, Bruce Ganase, Birgit Watson, P Richard Harrigan, Julio S G Montaner, Mark W Hull
BACKGROUND: As a simplification strategy for treatment-experienced HIV-infected patients who have achieved virologic suppression on a multi-drug, multi-class antiretroviral regimen, the aim of this study was to evaluate the safety, efficacy, and pharmacokinetics of once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disproxil fumarate (E/C/F/TDF) with darunavir. METHODS: A single arm, open-label 48-week study was conducted of regimen simplification to E/C/F/TDF plus darunavir 800 mg daily from stable therapy including two nucleoside/nucleotide reverse transcriptase inhibitors, a ritonavir-boosted protease inhibitor, and an integrase inhibitor...
November 2, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/29095954/pyrazinamide-clearance-is-impaired-among-hiv-tuberculosis-patients-with-high-levels-of-systemic-immune-activation
#12
Christopher Vinnard, Shruthi Ravimohan, Neo Tamuhla, Jotam Pasipanodya, Shashikant Srivastava, Chawangwa Modongo, Nicola M Zetola, Drew Weissman, Tawanda Gumbo, Gregory P Bisson
Pyrazinamide is the main driver of sterilizing effect in the standard regimen in adults and older children, and this effect is concentration-dependent. Tuberculosis patients co-infected with human immunodeficiency virus (HIV) have an increased risk for poor tuberculosis treatment outcomes and adverse drug events. We sought to determine whether measures of systemic immune activation were related to pyrazinamide pharmacokinetics among HIV/tuberculosis patients. We conducted a prospective cohort study of pyrazinamide pharmacokinetics in HIV/tuberculosis patients in Gaborone, Botswana...
2017: PloS One
https://www.readbyqxmd.com/read/29091230/2017-hiv-medicine-association-of-infectious-diseases-society-of-america-clinical-practice-guideline-for-the-management-of-chronic-pain-in-patients-living-with-human-immunodeficiency-virus
#13
R Douglas Bruce, Jessica Merlin, Paula J Lum, Ebtesam Ahmed, Carla Alexander, Amanda H Corbett, Kathleen Foley, Kate Leonard, Glenn Jordan Treisman, Peter Selwyn
Pain has always been an important part of human immunodeficiency virus (HIV) disease and its experience for patients. In this guideline, we review the types of chronic pain commonly seen among persons living with HIV (PLWH) and review the limited evidence base for treatment of chronic noncancer pain in this population. We also review the management of chronic pain in special populations of PLWH, including persons with substance use and mental health disorders. Finally, a general review of possible pharmacokinetic interactions is included to assist the HIV clinician in the treatment of chronic pain in this population...
October 30, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29079381/bariatric-surgery-in-hiv-patients-experience-of-an-obesity-reference-center-in-france
#14
Guillaume Pourcher, Gilles Peytavin, Luminita Schneider, Sébastien Gallien, Gilles Force, Valérie Pourcher
BACKGROUND: Few data on bariatric surgery are available regarding obese human immunodeficiency virus (HIV)-infected patients. SETTINGS: Antoine Beclere hospital, Clamart, Paris-sud University, France METHODS: Prospective observational follow-up study recruited HIV-infected patients who underwent bariatric surgery from 2009 to 2015. Baseline demographic characteristics, surgery characteristics, perioperative outcomes, changes in weight loss, HIV markers, antiretroviral drug plasma levels are described...
September 14, 2017: Surgery for Obesity and related Diseases: Official Journal of the American Society for Bariatric Surgery
https://www.readbyqxmd.com/read/29077230/risk-factors-contributing-to-a-low-darunavir-plasma-concentration
#15
A Daskapan, Y Stienstra, J G W Kosterink, W F W Bierman, T S van der Werf, D J Touw, J W C Alffenaar
Darunavir is an efficacious drug, however pharmacokinetic variability has been reported. The objective of this study was to find predisposing factors for low darunavir plasma concentrations in patients starting the once- or twice-daily dosage. Darunavir plasma concentrations from January 2010 till December 2014 of HIV-infected individuals treated in the outpatient clinic of the University Medical Center Groningen were retrospectively reviewed. The first darunavir plasma concentration of patients within 8 weeks after initiation of darunavir therapy was selected...
October 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29067253/evidence-based-review-of-statin-use-in-patients-with-hiv-on-antiretroviral-therapy
#16
REVIEW
Daniel B Chastain, Kayla R Stover, Daniel M Riche
INTRODUCTION: As a result of improved safe and effective therapeutic options for human immunodeficiency virus (HIV), life expectancy of those living with HIV is increasing leading to new challenges (e.g., management of chronic diseases). Some chronic diseases (e.g., cardiovascular disease [CVD]), are up to two times more prevalent in patients with HIV. Statins are a mainstay of therapy for prevention of CVD; but, clinicians should be aware that not all statins are appropriate for use in the HIV population, especially those receiving antiretroviral therapy (ART)...
June 2017: Journal of Clinical & Translational Endocrinology
https://www.readbyqxmd.com/read/29065172/concomitant-nevirapine-impacts-pharmacokinetic-exposure-to-the-antimalarial-artemether-lumefantrine-in-african-children
#17
Liusheng Huang, Vincent Carey, Jane C Lindsey, Florence Marzan, David Gingrich, Bobbie Graham, Linda Barlow-Mosha, Phionah K Ssemambo, Portia Kamthunzi, Sharon Nachman, Sunil Parikh, Francesca T Aweeka
BACKGROUND: The antiretroviral drug nevirapine and the antimalarial artemisinin-based combination therapy artemether-lumefantrine are commonly co-administered to treat malaria in the context of HIV. Nevirapine is a known inhibitor of cytochrome P450 3A4, which metabolizes artemether and lumefantrine. To address the concern that the antiretroviral nevirapine impacts the antimalarial artemether-lumefantrine pharmacokinetics, a prospective non-randomized controlled study in children presenting with uncomplicated malaria and HIV in sub-Saharan Africa was carried out...
2017: PloS One
https://www.readbyqxmd.com/read/29061131/proguanil-and-cycloguanil-are-organic-cation-transporter-and-multidrug-and-toxin-extrusion-substrates
#18
Maarten van der Velden, Albert Bilos, Jeroen J M W van den Heuvel, Sanna R Rijpma, Evelien G E Hurkmans, Robert W Sauerwein, Frans G M Russel, Jan B Koenderink
BACKGROUND: Malaria, HIV/AIDS, and tuberculosis endemic areas show considerable geographical overlap, leading to incidence of co-infections. This requires treatment with multiple drugs, potentially causing adverse drug-drug interactions (DDIs). As anti-malarials are generally positively charged at physiological pH, they are likely to interact with human organic cation transporters 1 and 2 (OCT1 and OCT2). These transporters are involved in the uptake of drugs into hepatocytes and proximal tubule cells for subsequent metabolic conversion or elimination...
October 23, 2017: Malaria Journal
https://www.readbyqxmd.com/read/29061086/pharmacogenetics-based-population-pharmacokinetic-analysis-of-tenofovir-in-thai-hiv-infected-patients
#19
Kanokrat Rungtivasuwan, Anchalee Avihingsanon, Narukjaporn Thammajaruk, Siwaporn Mitruk, David M Burger, Kiat Ruxrungtham, Chonlaphat Sukasem, Baralee Punyawudho
AIM: To develop a population pharmacokinetic model and identify sources of variability, genetic and nongenetic factors, of tenofovir. METHODS: The ABCC2 and ABCC4 polymorphisms were genotyped in 342 patients. A nonlinear mixed effects model was used to develop the population pharmacokinetic model and investigate the influence of these polymorphisms and other patient specific covariates on the pharmacokinetics of tenofovir. RESULTS: The estimated glomerular filtration rate calculated by the Cockcroft and Gault equation, concomitant use of lopinavir/ritonavir and ABCC4 3463A>G polymorphism were associated with tenofovir apparent oral clearance (CL/F)...
October 24, 2017: Pharmacogenomics
https://www.readbyqxmd.com/read/29059541/creation-of-a-nanoformulated-cabotegravir-prodrug-with-improved-antiretroviral-profiles
#20
Tian Zhou, Hang Su, Prasanta Dash, Zhiyi Lin, Bhagya Laxmi Dyavar Shetty, Ted Kocher, Adam Szlachetka, Benjamin Lamberty, Howard S Fox, Larisa Poluektova, Santhi Gorantla, JoEllyn McMillan, Nagsen Gautam, R Lee Mosley, Yazen Alnouti, Benson Edagwa, Howard E Gendelman
Long-acting parenteral (LAP) antiretroviral drugs have generated considerable interest for treatment and prevention of HIV-1 infection. One new LAP is cabotegravir (CAB), a highly potent integrase inhibitor, with a half-life of up to 54 days, allowing for every other month parenteral administrations. Despite this excellent profile, high volume dosing, injection site reactions and low body fluid drug concentrations affect broad use for virus infected and susceptible people. To improve the drug delivery profile, we created a myristoylated CAB prodrug (MCAB)...
October 15, 2017: Biomaterials
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