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HIV clinical trials

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https://www.readbyqxmd.com/read/29792230/community-health-worker-support-to-improve-hiv-treatment-outcomes-for-older-children-and-adolescents-in-zimbabwe-a-process-evaluation-of-the-zenith-trial
#1
Chido Dziva Chikwari, Victoria Simms, Joanna Busza, Ethel Dauya, Tsitsi Bandason, Prosper Chonzi, Shungu Munyati, Hilda Mujuru, Rashida A Ferrand
BACKGROUND: Community health worker (CHW)-delivered support visits to children living with HIV and their caregivers significantly reduced odds of virological failure among the children in the ZENITH trial conducted in Zimbabwe. We conducted a process evaluation to assess fidelity, acceptability, and feasibility of this intervention to identify lessons that could inform replication and scale-up of this approach. METHODS: Field manuals kept by each CHW, records from monthly supervisory meetings, and participant data collected throughout the trial were used to assess the intervention's implementation...
May 23, 2018: Implementation Science: IS
https://www.readbyqxmd.com/read/29789664/the-bet-bromodomain-inhibitor-apabetalone-induces-apoptosis-of-latent-hiv-1-reservoir-cells-following-viral-reactivation
#2
Xuan-Xuan Zhang, Jian Lin, Tai-Zhen Liang, Heng Duan, Xing-Hua Tan, Bao-Min Xi, Lin Li, Shu-Wen Liu
The persistence of latent HIV-1 reservoirs throughout combination antiretroviral therapy (cART) is a major barrier on the path to achieving a cure for AIDS. It has been shown that bromodomain and extra-terminal (BET) inhibitors could reactivate HIV-1 latency, but restrained from clinical application due to their toxicity and side effects. Thus, identifying a new type of BET inhibitor with high degrees of selectivity and safety is urgently needed. Apabetalone is a small-molecule selective BET inhibitor specific for second bromodomains, and has been evaluated in phase III clinical trials that enrolled patients with high-risk cardiovascular disorders, dyslipidemia, and low HDL cholesterol...
May 22, 2018: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/29788156/systemic-inflammation-markers-after-simplification-to-atazanavir-ritonavir-plus-lamivudine-in-virologically-suppressed-hiv-1-infected-patients-atlas-m-substudy
#3
Simone Belmonti, Francesca Lombardi, Eugenia Quiros-Roldan, Alessandra Latini, Antonella Castagna, Alberto Borghetti, Gianmaria Baldin, Arturo Ciccullo, Roberto Cauda, Andrea De Luca, Simona Di Giambenedetto
Background: Biomarkers of systemic inflammation predict non-AIDS events and overall mortality in virologically suppressed HIV-1-infected patients. Objectives: To determine whether switching to a dual antiretroviral maintenance therapy was associated with modification of biomarkers of systemic inflammation as compared with continuation of successful standard triple therapy. Methods: In this substudy of the randomized ATLAS-M trial, we compared in virologically suppressed patients the impact at 1 year of simplification to a dual therapy with atazanavir/ritonavir plus lamivudine versus maintaining atazanavir/ritonavir plus two NRTI triple therapy on markers of systemic inflammation...
April 17, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29788075/effects-of-immunonutrition-in-advanced-hiv-disease-a-randomized-placebo-controlled-clinical-trial-promaltia-study
#4
Sergio Serrano-Villar, María de Lagarde, Jorge Vázquez-Castellanos, Alejandro Vallejo, J Ignacio Bernadino, Nadia Madrid, Mariano Matarranz, Alberto Díaz-Santiago, Carolina Gutiérrez, Alfonso Cabello, Judit Villar-García, José Ramón Blanco, Otilia Bisbal, Talía Sainz, Andrés Moya, Santiago Moreno, María José Gosalbes, Vicente Estrada
Background: While nutritional interventions with prebiotics and probiotics seem to exert immunological effects, their clinical implications in HIV-infected subjects initiating ART at advanced HIV disease remain unclear. Methodology: Pilot multicenter randomized, placebo-controlled, double-blind study in which 78 HIV-infected, ART-naive subjects with <350 CD4 T-cells/µl or AIDS were randomized to either daily PMT25341 (a mixture of prebiotics, probiotics, oligonutrients, DHA, EPA, GLA, and aminoacids) or placebo for 48 weeks, each in combination with first-line ART...
May 16, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29786768/risk-prediction-score-for-hiv-infection-development-and-internal-validation-with-cross-sectional-data-from-men-who-have-sex-with-men-in-china
#5
Lu Yin, Yuejuan Zhao, Meridith Blevins Peratikos, Liang Song, Xiangjun Zhang, Ruolei Xin, Zheya Sun, Yunan Xu, Li Zhang, Yifei Hu, Chun Hao, Yuhua Ruan, Yiming Shao, Sten H Vermund, Han-Zhu Qian
Receptive anal intercourse, multiple partners, condomless sex, sexually transmitted infections (STIs), and drug/alcohol addiction are familiar factors that correlate with increased human immunodeficiency virus (HIV) risk among men who have sex with men (MSM). To improve estimation to HIV acquisition, we created a composite score using questions from routine survey of 3588 MSM in Beijing, China. The HIV prevalence was 13.4%. A risk scoring tool using penalized maximum likelihood multivariable logistic regression modeling was developed, deploying backward step-down variable selection to obtain a reduced-form model...
May 21, 2018: AIDS and Behavior
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
#6
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/29783991/admission-eeg-findings-in-diverse-paediatric-cerebral-malaria-populations-predict-outcomes
#7
Douglas G Postels, Xiaoting Wu, Chenxi Li, Peter W Kaplan, Karl B Seydel, Terrie E Taylor, Youssef A Kousa, Richard Idro, Robert Opoka, Chandy C John, Gretchen L Birbeck
BACKGROUND: Electroencephalography at hospital presentation may offer important insights regarding prognosis that can inform understanding of cerebral malaria (CM) pathophysiology and potentially guide patient selection and risk stratification for future clinical trials. Electroencephalogram (EEG) findings in children with CM in Uganda and Malawi were compared and associations between admission EEG findings and outcome across this diverse population were assessed. Demographic, clinical and admission EEG data from Ugandan and Malawian children admitted from 2009 to 2012 with CM were gathered, and survivors assessed for neurological abnormalities at discharge...
May 22, 2018: Malaria Journal
https://www.readbyqxmd.com/read/29781885/improved-cognitive-performance-and-reduced-monocyte-activation-in-virally-suppressed-chronic-hiv-following-dual-ccr2-and-ccr5-antagonism
#8
Michelle L D'Antoni, Robert H Paul, Brooks I Mitchell, Lindsay Kohorn, Laurent Fischer, Eric Lefebvre, Star Seyedkazemi, Beau K Nakamoto, Maegen Walker, Kalpana J Kallianpur, Debra Ogata-Arakaki, Lishomwa C Ndhlovu, Cecilia Shikuma
OBJECTIVE: To evaluate changes in neuropsychological (NP) performance and in plasma and cell surface markers of peripheral monocyte activation/migration following treatment with cenicriviroc (CVC), a dual C-C chemokine receptor type 2 (CCR2) and type 5 (CCR5) antagonist, in treatment-experienced, HIV-infected individuals. SETTING: Single-arm, 24-week, open-label clinical trial. METHODS: HIV-infected individuals on antiretroviral therapy (ART) >1 year with plasma HIV RNA <50 copies/ml and below-normal cognitive performance [defined as age, gender and education-adjusted NP performance (NPZ) <-0...
May 16, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29781359/rhabdoviruses-as-vaccine-platforms-for-infectious-disease-and-cancer
#9
Franz Zemp, Jahanara Rajwani, Douglas J Mahoney
The family Rhabdoviridae (RV) comprises a large, genetically diverse collection of single-stranded, negative sense RNA viruses from the order Mononegavirales. Several RV members are being developed as live-attenuated vaccine vectors for the prevention or treatment of infectious disease and cancer. These include the prototype recombinant Vesicular Stomatitis Virus (rVSV) and the more recently developed recombinant Maraba Virus, both species within the genus Vesiculoviridae. A relatively strong safety profile in humans, robust immunogenicity and genetic malleability are key features that make the RV family attractive vaccine platforms...
May 21, 2018: Biotechnology & Genetic Engineering Reviews
https://www.readbyqxmd.com/read/29779976/the-discovery-and-preclinical-evaluation-of-bms-707035-a-potent-hiv-1-integrase-strand-transfer-inhibitor
#10
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/29779350/-a-phase-%C3%A2-multi-center-clinical-trial-on-safety-and-efficacy-of-a-domestic-plasma-derived-factor-%C3%A2-for-the-treatment-of-patients-with-hemophilia-b
#11
W Liu, R F Fu, Y W Zhou, Y Chen, J Yin, Z Q Yu, L H Yang, M F Wang, H Bi, Z P Zhou, X S Zhang, J L Xia, R C Yang
Objective: To evaluate the efficacy and safety of a domestic human plasma derived coagulation Factor Ⅸ concentrate (pd-FⅨ) in patients with hemophilia B. Methods: The study was a multicenter, open-label and single-arm study. The efficacy of pd-F Ⅸ was evaluated by objective performance criteria. The doses of pd-FⅨ were calculated according to the bleeding symptom and disease severity. The infusion efficiency of pd-FⅨ and improvement of bleeding symptoms were measured at 30 minutes and (24±4) h after the first infusion, respectively...
May 14, 2018: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29777162/hiv-and-vertebral-fractures-a-systematic-review-and-metanalysis
#12
Thales A S H Ilha, Fabio V Comim, Rafaela M Copes, Juliet E Compston, Melissa O Premaor
The survival of HIV-infected patients has increased with the advent of antiretroviral therapy with the emergence of new comorbidities. Vertebral fracture is a manifestation of reduced bone strength and osteoporosis. This study aims to assess the frequency of spine fractures in HIV-positive men and women aged over 18 years. We performed a systematic review of randomized controlled trials, cohort studies, cross-sectional studies, and case-control studies. Studies that evaluated morphometric and/or clinical vertebral fracture were included...
May 18, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29772941/recent-advances-in-the-discovery-and-development-of-tlr-ligands-as-novel-therapeutics-for-chronic-hbv-and-hiv-infections
#13
Keye Du, Jia Liu, Ruth Broering, Xiaoyong Zhang, Dongliang Yang, Ulf Dittmer, Mengji Lu
Toll-like receptor (TLR) ligands remain as promising antiviral drug candidates for the treatment of chronic viral infections. Basic research on the mechanisms of antiviral activity of TLR ligands in preclinical animal models and clinical testing of drug candidates have been carried out in recent years. Areas covered: This review provides an overview of the preclinical and clinical testing of TLR ligands in two major viral infections: hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Recent results have further demonstrated the potent antiviral activity of various TLR ligands ...
May 17, 2018: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/29772028/randomized-phase-i-trial-hiv-core-003-depletion-of-serum-amyloid-p-component-and-immunogenicity-of-dna-vaccination-against-hiv-1
#14
Nicola J Borthwick, Thirusha Lane, Nathifa Moyo, Alison Crook, Jung Min Shim, Ian Baines, Edmund G Wee, Philip N Hawkins, Julian D Gillmore, Tomáš Hanke, Mark B Pepys
BACKGROUND: The failure of DNA vaccination in humans, in contrast to its efficacy in some species, is unexplained. Observational and interventional experimental evidence suggests that DNA immunogenicity may be prevented by binding of human serum amyloid P component (SAP). SAP is the single normal DNA binding protein in human plasma. The drug (R)-1-[6-[(R)-2-carboxypyrrolidin-1-yl]-6-oxo-hexanoyl]pyrrolidine-2-carboxylic acid (CPHPC, miridesap), developed for treatment of systemic amyloidosis and Alzheimer's disease, depletes circulating SAP by 95-99%...
2018: PloS One
https://www.readbyqxmd.com/read/29769116/efficacies-of-cabotegravir-and-bictegravir-against-drug-resistant-hiv-1-integrase-mutants
#15
Steven J Smith, Xue Zhi Zhao, Terrence R Burke, Stephen H Hughes
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) are the class of antiretroviral (ARV) drugs most recently approved by the FDA for the treatment of HIV-1 infections. INSTIs block the strand transfer reaction catalyzed by HIV-1 integrase (IN) and have been shown to potently inhibit infection by wild-type HIV-1. Of the three current FDA-approved INSTIs, Dolutegravir (DTG), has been the most effective, in part because treatment does not readily select for resistant mutants. However, recent studies showed that when INSTI-experienced patients are put on a DTG-salvage therapy, they have reduced response rates...
May 16, 2018: Retrovirology
https://www.readbyqxmd.com/read/29769038/impact-of-new-daa-therapy-on-real-clinical-practice-a-multicenter-region-wide-cohort-study
#16
Simone Lanini, Paola Scognamiglio, Alessandra Mecozzi, Lorella Lombardozzi, Vincenzo Vullo, Mario Angelico, Antonio Gasbarrini, Gloria Taliani, Adolfo Francesco Attili, Carlo Federico Perno, Adriano De Santis, Vincenzo Puro, Fabio Cerqua, Gianpiero D'Offizi, Adriano Pellicelli, Orlando Armignacco, Francesco Saverio Mennini, Massimo Siciliano, Enrico Girardi, Vincenzo Panella, Giuseppe Ippolito
BACKGROUND: Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. METHODS: The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not...
May 16, 2018: BMC Infectious Diseases
https://www.readbyqxmd.com/read/29768662/immersion-in-water-during-labour-and-birth
#17
REVIEW
Elizabeth R Cluett, Ethel Burns, Anna Cuthbert
BACKGROUND: Water immersion during labour and birth is increasingly popular and is becoming widely accepted across many countries, and particularly in midwifery-led care settings. However, there are concerns around neonatal water inhalation, increased requirement for admission to neonatal intensive care unit (NICU), maternal and/or neonatal infection, and obstetric anal sphincter injuries (OASIS). This is an update of a review last published in 2011. OBJECTIVES: To assess the effects of water immersion during labour and/or birth (first, second and third stage of labour) on women and their infants...
May 16, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29768174/hiv-1-vaccines-based-on-antibody-identification-b-cell-ontogeny-and-epitope-structure
#18
REVIEW
Peter D Kwong, John R Mascola
HIV-1 vaccine development has been stymied by an inability to induce broadly reactive neutralizing antibodies to the envelope (Env) trimer, the sole viral antigen on the virion surface. Antibodies isolated from HIV-1-infected donors, however, have been shown to recognize all major exposed regions of the prefusion-closed Env trimer, and an emerging understanding of the immunological and structural characteristics of these antibodies and the epitopes they recognize is enabling new approaches to vaccine design...
May 15, 2018: Immunity
https://www.readbyqxmd.com/read/29767543/efficacy-of-single-tablet-darunavir-cobicistat-emtricitabine-and-tenofovir-alafenamide-in-the-treatment-of-hiv-1
#19
Eugènia Negredo, Bonaventura Clotet
HIV eradication is not feasible and lifelong treatment is warranted to manage HIV infection. In this scenario, the advent of single-tablet, once-daily, fixed-dose co-formulations is important for reducing pill burden and maximize long-term drug adherence. Cobicistat-boosted darunavir along with emtricitabine and tenofovir alafenamide co-formulation (DRV/c/FTC/TAF or the trade name Symtuza®) is the first marketed protease inhibitor-based fixed-dose combination regimen for the treatment of HIV infection. It was approved in late 2017 by the European Medical Agency both for naïve patients and treatment-experienced patients with viral suppression...
May 16, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29762365/multiplex-real-time-pcr-detection-of-intestinal-protozoa-in-hiv-infected-children-in-malawi-enterocytozoon-bieneusi-is-common-and-associated-with-gastrointestinal-complaints-and-may-delay-bmi-nutritional-status-recovery
#20
Minke H W Huibers, Peter Moons, Nelson Maseko, Monfort B Gushu, Oluwadamilola H Iwajomo, Robert S Heyderman, Michael Boele van Hensbroek, Eric A Brienen, Lisette van Lieshout, Job C J Calis
BACKGROUND: Intestinal protozoa are common opportunistic infections in HIV patients. Longitudinal studies on either the clinical relevance, or the effect of immune reconstitution by anti-retroviral therapy on intestinal protozoan infections are children is lacking however. This study investigates prevalence and clinical relevance of intestinal protozoa in HIV-infected Malawian children prior to and during their first year of ART. METHODS: Stool samples collected at enrolment and during follow-up were tested for non-opportunistic (Giardia lamblia, Dientamoeba fragilis, Entamoeba histolytica) and opportunistic protozoa (Entroctytoon bieneusi, Encephalitozoon spp...
May 14, 2018: Pediatric Infectious Disease Journal
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