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Hiv and pharmacokinetics

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https://www.readbyqxmd.com/read/29784846/pharmacokinetics-of-piperaquine-and-safety-profile-of-dihydroartemisinin-piperaquine-co-administered-with-antiretroviral-therapy-in-malaria-uninfected-hiv-positive-malawian-adults
#1
Clifford G Banda, Fraction Dzinjalamala, Mavuto Mukaka, Jane Mallewa, Victor Maiden, Dianne J Terlouw, David G Lalloo, Saye H Khoo, Victor Mwapasa
There are limited data on the pharmacokinetic and safety profiles of dihydroartemisinin-piperaquine (DHA-PQ) among human immunodeficiency virus infected (HIV+) individuals taking antiretroviral therapy (ART). In a two step (parallel-group) pharmacokinetic trial with intensive blood sampling, we compared area under the concentration-time curve (AUC0-28 days ) and safety outcomes of piperaquine among malaria-uninfected HIV+ adults. In step 1, half the adult dose of DHA-PQ was administered for three days as an intitial safety check in four groups (n=6/group) of HIV+ adults (age≥18 years): (i) antiretroviral-naïve, (ii) on nevirapine-based ART, (iii) on efavirenz-based ART, and (iv) on ritonavir-boosted lopinavir-based ART...
May 21, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29781044/sleeve-gastrectomy-in-morbidly-obese-hiv-patients-focus-on-anti-retroviral-treatment-absorption-after-surgery
#2
Chloé Amouyal, Marion Buyse, Lea Lucas-Martini, Déborah Hirt, Laurent Genser, Adriana Torcivia, Jean-Luc Bouillot, Jean-Michel Oppert, Judith Aron-Wisnewsky
CONTEXT: Anti-retroviral therapy (ART) dramatically reduced AIDS development, thus enabling patients to live as long as the general population. New challenges have emerged particularly cardiometabolic diseases and weight gain, with some HIV patients seeking bariatric surgery (BS). However, BS outcomes during HIV remain poorly described, with scarce data on ART pharmacokinetic post-BS. OBJECTIVE: Describing sleeve gastrectomy (SG) results in HIV patients in terms of ART pharmacokinetic, HIV control, weight loss, and metabolic outcomes...
May 20, 2018: Obesity Surgery
https://www.readbyqxmd.com/read/29779976/the-discovery-and-preclinical-evaluation-of-bms-707035-a-potent-hiv-1-integrase-strand-transfer-inhibitor
#3
B Narasimhulu Naidu, Michael A Walker, Margaret E Sorenson, Yasutsugu Ueda, John D Matiskella, Timothy P Connolly, Ira B Dicker, Zeyu Lin, Sagarika Bollini, Brian J Terry, Helen Higley, Ming Zheng, Dawn D Parker, Dedong Wu, Stephen Adams, Mark R Krystal, Nicholas A Meanwell
BMS-707035 is an HIV-1 integrase strand transfer inhibitor (INSTI) discovered by systematic optimization of N-methylpyrimidinone carboxamides guided by structure-activity relationships (SARs) and the single crystal X-ray structure of compound 10. It was rationalized that the unexpectedly advantageous profiles of N-methylpyrimidinone carboxamides with a saturated C2-substitutent may be due, in part, to the geometric relationship between the C2-substituent and the pyrimidinone core. The single crystal X-ray structure of 10 provided support for this reasoning and guided the design of a spirocyclic series 12 which led to discovery of the morpholino-fused pyrimidinone series 13...
May 14, 2018: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/29777772/improving-maraviroc-oral-bioavailability-by-formation-of-solid-drug-nanoparticles
#4
Alison C Savage, Lee M Tatham, Marco Siccardi, Trevor Scott, Manoli Vourvahis, Andrew Clark, Steve P Rannard, Andrew Owen
Oral drug administration remains the preferred approach for treatment of HIV in most patients. Maraviroc (MVC) is the first in class co-receptor antagonist, which blocks HIV entry into host cells. MVC has an oral bioavailability of approximately 33%, which is limited by poor permeability as well as affinity for CYP3A and several drug transporters. While once-daily doses are now the favoured option for HIV therapy, dose-limiting postural hypotension has been of theoretical concern when administering doses high enough to achieve this for MVC (particularly during coadministration of enzyme inhibitors)...
May 16, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29771285/increased-dolutegravir-peak-concentrations-in-people-living-with-hiv-aged-60-and-over-and-analysis-of-sleep-quality-and-cognition
#5
Emilie R Elliot, Xinzhu Wang, Suveer Singh, Bryony Simmons, Jaime H Vera, Robert F Miller, Colin Fitzpatrick, Graeme Moyle, Myra McClure, Marta Boffito
Background: Demographic data show an increasingly aging HIV population worldwide. Recent concerns over dolutegravir-related neuropsychiatric toxicity have emerged, particularly amongst older HIV patients. We describe the pharmacokinetics (PK) of dolutegravir (DTG) 50mg once daily in people living with HIV (PLWH) aged 60 and older. Additionally, to address the call for prospective neuropsychiatric toxicodynamic data, we evaluate changes in sleep quality and cognitive function after switching to abacavir (ABC)/lamivudine (3TC)/DTG, over 6 months in this population...
May 16, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29767639/pharmacokinetics-and-pharmacodynamics-of-tenofovir-reduced-glycerin-1-gel-in-the-rectal-and-vaginal-compartments-in-women-a-cross-compartmental-study-with-directly-observed-dosing
#6
Jessica E Justman, Gonasagrie Lulu Nair, Craig W Hendrix, Jeanna M Piper, Mark A Marzinke, James Y Dai, Zhenyu Pan, Beth Galaska, Lisa Levy, Jill L Schwartz, Bhavna Balar, Ratiya P Kunjara Na Ayudhya, Ivy Mushamiri, Ian McGowan, Charlene S Dezzutti
BACKGROUND: Evidence is lacking regarding whether vaginal pre-exposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition. SETTING: Bronx, NY. METHODS: MTN-014 was a phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases...
June 1, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29761350/effects-of-gel-volume-on-pharmacokinetics-for-vaginal-and-rectal-applications-of-combination-duogel-iqb4012-a-dual-chamber-dual-drug-hiv-microbicide-gel-in-pigtailed-macaques
#7
Lara E Pereira, Tyana Singletary, Amy Martin, Chuong T Dinh, Frank Deyounks, Angela Holder, Janet McNicholl, Karen W Buckheit, Robert W Buckheit, Anthony Ham, David F Katz, James M Smith
This study evaluated effects of differing gel volumes on pharmacokinetics (PK). IQB4012, a gel containing the non-nucleoside reverse transcriptase inhibitor IQP-0528 and tenofovir (TFV), was applied to the pigtailed macaque vagina and rectum. Vaginal gel volumes (1% loading of both drugs) were 0.5 or 1.5 ml; following wash-out, 1 or 4 ml of gel were then applied rectally. Blood, vaginal, and rectal fluids were collected at 0, 2, 4, and 24 h. Vaginal and rectal tissue biopsies were collected at 4 and 24 h...
May 14, 2018: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29760133/pharmacokinetics-and-safety-profile-of-artesunate-amodiaquine-co-administered-with-antiretroviral-therapy-in-malaria-uninfected-hiv-positive-malawian-adults
#8
Clifford G Banda, Fraction Dzinjalamala, Mavuto Mukaka, Jane Mallewa, Victor Maiden, Dianne J Terlouw, David G Lalloo, Saye H Khoo, Victor Mwapasa
There are limited data on the pharmacokinetic and safety profiles of artesunate-amodiaquine in human immnunodeficiency virus infected (HIV+) individuals receiving antiretroviral therapy. In a two-step intensive sampling pharmacokinetic trial, we compared area under the concentration-time curve from 0 to 28 days (AUC0-28 days ) of an active metabolite of amodiaquine, desethylamodiaquine, and treatment-emergent adverse events between antiretroviral therapy-naive HIV+ adults and those taking nevirapine and ritonavir-boosted lopinavir-based antiretroviral therapy...
May 14, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29760129/pharmacokinetic-changes-during-pregnancy-according-to-genetic-variants-a-prospective-study-in-hiv-infected-patients-receiving-atazanavir-ritonavir
#9
Emanuele Focà, Andrea Calcagno, Andrea Bonito, Jessica Cusato, Elisabetta Domenighini, Antonio D'Avolio, Eugenia Quiros Roldan, Laura Trentini, Filippo Castelnuovo, Giovanni Di Perri, Francesco Castelli, Stefano Bonora
Atazanavir/ritonavir concentrations change over pregnancy in HIV-positive patients; the impact of genetic variants is unknown. 20 patients were enrolled: antiretrovirals' plasma and intracellular concentrations were measured in addition to single nucleotide polymorphisms in transport affecting genes. Linear logistic regression showed that genetic variants in organic-anion-transporter-1B1 and pregnane-X-receptor encoding genes affected third trimester atazanavir exposure. In this prospective study genetic variants partially explained the observed inter-patient variability in third-trimester antiretrovirals' exposure...
May 14, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29758049/user-evaluations-offer-promise-for-pod-intravaginal-ring-as-a-drug-delivery-platform-a-mixed-methods-study-of-acceptability-and-use-experiences
#10
Kate M Guthrie, Rochelle K Rosen, Sara E Vargas, Melissa L Getz, Lauren Dawson, Melissa Guillen, Jaime J Ramirez, Marc M Baum, Kathleen L Vincent
BACKGROUND: Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user's experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process...
2018: PloS One
https://www.readbyqxmd.com/read/29746648/effects-of-sofosbuvir-based-hepatitis-c-treatment-on-the-pharmacokinetics-of-tenofovir-in-hiv-hcv-coinfected-individuals-receiving-tenofovir-disoproxil-fumarate
#11
Christine E MacBrayne, Kristen M Marks, Daniel S Fierer, Susanna Naggie, Raymond T Chung, Michael D Hughes, Arthur Y Kim, Marion G Peters, Diana M Brainard, Sharon M Seifert, Jose R Castillo-Mancilla, Lane R Bushman, Peter L Anderson, Jennifer J Kiser
Background: The nucleotide analogues tenofovir and sofosbuvir are considered to have low potential for drug interactions. Objectives: To determine the effect of sofosbuvir-based HCV treatment on plasma concentrations of tenofovir and cellular concentrations of tenofovir diphosphate. Methods: HIV-infected participants with acute HCV were treated for 12 weeks with sofosbuvir + ribavirin in Cohort 1 or 8 weeks with ledipasvir/sofosbuvir in Cohort 2 of AIDS Clinical Trials Group study 5327...
May 9, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29746294/a-maintenance-three-day-per-week-schedule-with-the-single-tablet-regimen-efavirenz-emtricitabine-tenofovir-disoproxil-fumarate-is-effective-and-decreases-sub-clinical-toxicity-the-a-tri-week-pilot-trial
#12
Jhon Rojas, Jose L Blanco, Sonsoles Sanchez-Palomino, Maria A Marcos, Alberto C Guardo, Ana Gonzalez-Cordon, Montserrat Lonca, Amparo Tricas, Ana Rodriguez, Anabel Romero, Jose M Miro, Josep Mallolas, Jose M Gatell, Montserrat Plana, Esteban Martinez
BACKGROUND: Antiretroviral drugs contained in single tablet Atripla® have pharmacokinetic properties that could allow for longer than once-daily (OD) dosing. We hypothesized that simplifying Atripla® OD to 3-day per week would be feasible, able to maintain viral suppression and less toxic. METHODS: Virologically suppressed (≥2 years) HIV+ adults on Atripla® OD, CD4 >350/mm at inclusion, and no prior documented virological failure or evidence of resistance mutations to efavirenz, tenofovir, or emtricitabine were randomized to maintain their OD regimen or to reduce it to 3 days (Mondays, Wednesdays, and Fridays) a week (3W)...
May 9, 2018: AIDS
https://www.readbyqxmd.com/read/29746268/bictegravir
#13
Vincenzo Spagnuolo, Antonella Castagna, Adriano Lazzarin
PURPOSE OF REVIEW: In this review, we will highlight and discuss the recent efficacy and safety data of bictegravir (BIC), a novel second-generation integrase strand transfer inhibitor (INSTI) that has been recently approved, in coformulation with emtricitabine and tenofovir alafenamide (B/F/TAF), for the treatment of HIV-1 infection in antiretroviral naïve subjects and in those with suppressed viremia. RECENT FINDINGS: Preclinical data showed that BIC has a genetic barrier that is higher than that of raltegravir and elvitegravir but is similar to that of dolutegravir (DTG), with retained activity in vitro against isolates containing substitutions associated with resistance against other INSTIs...
May 4, 2018: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29742062/global-perspective-of-novel-therapeutic-strategies-for-the-management-of-neuroaids
#14
Swatantra Kumar, Vimal K Maurya, Himanshu R Dandu, Madan Lb Bhatt, Shailendra K Saxena
Among Human immunodeficiency virus (HIV) infected individuals, around two-thirds of patients present with neuroAIDS, where HIV-associated neurocognitive disorders (HAND), and HIV-associated dementia (HAD) are the most prevailing neurological complications. The neuropathology of neuroAIDS can be characterized by the presence of HIV infected macrophages and microglia in the brain, with the formation of multinucleated giant cells. Global predominant subtypes of HIV-1 clade B and C infections influence the differential effect of immune and neuronal dysfunctions, leading to clade-specific clinical variation in neuroAIDS patient cohorts...
May 8, 2018: Biomolecular Concepts
https://www.readbyqxmd.com/read/29727296/croi-2018-advances-in-antiretroviral-therapy
#15
Hong-Van Tieu, Barbara S Taylor, Joyce Jones, Timothy J Wilkin
The 2018 Conference on Retroviruses and Opportunistic Infections (CROI) showcased exciting data on new investigational agents including MK-8591 and tri-specific antibody targeting 3 highly conserved epitopes on HIV-1 in a single antibody. Clinical trials of initial antiretroviral therapy (ART) and switch studies involving bictegravir/emtricitabine/tenofovir alafenamide were presented. Intensification of initial ART with integrase strand transfer inhibitors did not increase the risk of immune reconstitution inflammatory syndrome...
May 2018: Topics in Antiviral Medicine
https://www.readbyqxmd.com/read/29723705/nanoparticle-in-microparticle-oral-drug-delivery-system-of-a-clinically-relevant-darunavir-ritonavir-antiretroviral-combination
#16
Robin Augustine, Dana Levin Ashkenazi, Roni Sverdlov Arzi, Vita Zlobin, Rona Shofti, Alejandro Sosnik
Nanonizationhas been extensively investigated to increase theoral bioavailability of hydrophobicdrugsin general andantiretrovirals(ARVs)used inthe therapy of the human immunodeficiency virus (HIV) infection in particular. Weanticipatedthatin the caseofprotease inhibitors, a family of pH-dependent ARVsthatdisplay high aqueous solubility undertheacidconditionsof thestomach andextremely low solubilityunder the neutral ones ofthe small intestine, this strategy will failowing to an uncontrolled dissolution-re-precipitation process that will take place along the gastrointestinal tract...
April 30, 2018: Acta Biomaterialia
https://www.readbyqxmd.com/read/29721582/darunavir-concentration-in-pbmcs-may-be-a-better-indicator-of-drug-exposure-in-hiv-patients
#17
Daisuke Nagano, Takuya Araki, Kunio Yanagisawa, Yoshiyuki Ogawa, Fumito Gohda, Hideki Uchiumi, Hiroshi Handa, Tomonori Nakamura, Koujirou Yamamoto
PURPOSE: The clinical efficacies of some antiretroviral drugs are known to not depend on its concentration in blood. To establish a method of dosage adjustment for darunavir (DRV) based on pharmacokinetic theory, we analyzed the correlation between DRV levels in peripheral blood mononuclear cells (PBMCs) and plasma. METHODS: The concentrations of DRV and ritonavir (RTV) in plasma and PBMCs of 31 samples obtained from 19 patients were analyzed. An in vitro kinetic study using MOLT-4 cells was performed to assess the contribution of RTV to the intracellular accumulation of DRV...
May 2, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29714824/physiologically-based-pharmacokinetic-model-of-vaginally-administered-dapivirine-ring-and-film-formulations
#18
Katherine Kay, Dhaval K Shah, Lisa Rohan, Robert Bies
AIMS: A physiologically-based pharmacokinetic (PBPK) model of the vaginal space was developed with the aim of predicting concentrations in the vaginal and cervical space. These predictions can be used to optimize the probability of success of vaginally administered dapivirine (DPV) for HIV prevention. We focus on vaginal delivery using either a ring [1] or film [2]. METHODS: A PBPK model describing the physiological structure of the vaginal tissue and fluid was defined mathematically and implemented in MATLAB...
May 1, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29714167/virological-and-immunological-responses-to-raltegravir-and-dolutegravir-in-the-gut-associated-lymphoid-tissue-of-hiv-infected-men-and-women
#19
Michael D Weber, Elizabeth Andrews, Heather A Prince, Craig Sykes, Elias P Rosen, Camden Bay, Nicholas J Shaheen, Ryan D Madanick, Evan S Dellon, Kristina De Paris, Julie Ae Nelson, Cynthia L Gay, Angela Dm Kashuba
BACKGROUND: Raltegravir (RTG) and dolutegravir (DTG) have different pharmacokinetic patterns in the gastrointestinal tract. To determine if this results in pharmacodynamic differences, we compared HIV RNA, HIV DNA, and immunological markers in gut-associated lymphoid tissue (GALT) of HIV-infected participants receiving RTG or DTG with tenofovir+emtricitabine (TDF/FTC). METHODS: GALT specimens from the terminal ileum, splenic flexure, and rectum were obtained by colonoscopy at a single time point in 20 adults treated with RTG (n=10) or DTG (n=10) with HIV RNA <50 copies/mL...
May 1, 2018: Antiviral Therapy
https://www.readbyqxmd.com/read/29697469/broadly-neutralizing-antibodies-for-treatment-and-prevention-of-hiv-1-infection
#20
Yehuda Z Cohen, Marina Caskey
PURPOSE OF REVIEW: Several anti-HIV-1 broadly neutralizing antibodies (bNAbs) with exceptional breadth and potency that target different HIV-1 envelope epitopes have been identified. bNAbs are an attractive new strategy for HIV-1 prevention and therapy, and potentially, for long-term remission or cure. Here, we discuss findings from early clinical studies that have evaluated these novel bNAbs. RECENT FINDINGS: Phase 1 studies of bNAbs targeting two distinct HIV-1 envelope epitopes have demonstrated their favorable safety and pharmacokinetic profile...
April 24, 2018: Current Opinion in HIV and AIDS
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