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HIV clinical trials

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https://www.readbyqxmd.com/read/29141153/using-observational-data-to-calibrate-simulation-models
#1
Eleanor J Murray, James M Robins, George R Seage, Sara Lodi, Emily P Hyle, Krishna P Reddy, Kenneth A Freedberg, Miguel A Hernán
BACKGROUND: Individual-level simulation models are valuable tools for comparing the impact of clinical or public health interventions on population health and cost outcomes over time. However, a key challenge is ensuring that outcome estimates correctly reflect real-world impacts. Calibration to targets obtained from randomized trials may be insufficient if trials do not exist for populations, time periods, or interventions of interest. Observational data can provide a wider range of calibration targets but requires methods to adjust for treatment-confounder feedback...
November 1, 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/29140587/comparison-of-haematology-and-biochemistry-parameters-in-healthy-south-african-infants-with-laboratory-reference-intervals
#2
B Schmidt, M Tameris, H Geldenhuys, A Luabeya, E Bunyasi, T Hawkridge, J B McClain, H Mahomed, T J Scriba, H McShane, M Hatherill
OBJECTIVE: Paediatric laboratory reference intervals used in Africa and Asia may be derived from historical intervals of predominantly Caucasian infants in Europe or North America. These intervals may therefore not be compatible with the range of normality for developing country populations. We aimed to compare haematology and biochemistry parameters in healthy South African infants with local laboratory reference intervals. METHODS: We compared the baseline haematology and biochemistry results of 634 (316 male and 318 female) HIV-unexposed infants, aged 3-6 months, living in a rural area of the Western Cape Province, South Africa, against laboratory reference intervals supplied by the South African National Health Laboratory Services (NHLS)...
November 15, 2017: Tropical Medicine & International Health: TM & IH
https://www.readbyqxmd.com/read/29139110/unconditional-cash-transfers-for-reducing-poverty-and-vulnerabilities-effect-on-use-of-health-services-and-health-outcomes-in-low-and-middle-income-countries
#3
REVIEW
Frank Pega, Sze Yan Liu, Stefan Walter, Roman Pabayo, Ruhi Saith, Stefan K Lhachimi
BACKGROUND: Unconditional cash transfers (UCTs; provided without obligation) for reducing poverty and vulnerabilities (e.g. orphanhood, old age or HIV infection) are a type of social protection intervention that addresses a key social determinant of health (income) in low- and middle-income countries (LMICs). The relative effectiveness of UCTs compared with conditional cash transfers (CCTs; provided so long as the recipient engages in prescribed behaviours such as using a health service or attending school) is unknown...
November 15, 2017: Cochrane Database of Systematic Reviews
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
#4
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/29136001/a-combination-intervention-strategy-to-improve-linkage-to-and-retention-in-hiv-care-following-diagnosis-in-mozambique-a-cluster-randomized-study
#5
Batya Elul, Matthew R Lamb, Maria Lahuerta, Fatima Abacassamo, Laurence Ahoua, Stephanie A Kujawski, Maria Tomo, Ilesh Jani
BACKGROUND: Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique. METHODS AND FINDINGS: In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29135907/efavirenz-therapeutic-range-in-hiv-1-treatment-naive-participants
#6
Cindy J Bednasz, Charles S Venuto, Qing Ma, Eric S Daar, Paul E Sax, Margaret A Fischl, Ann C Collier, Kimberly Y Smith, Camlin Tierney, Yang Yang, Gregory E Wilding, Gene D Morse
BACKGROUND: Efavirenz is currently suggested as an alternative to recommended antiretroviral (ARV) regimens by the Department of Health and Human Services for the treatment of HIV-1 in ARV-naive patients. A mid-dosing interval therapeutic range between 1000 and 4000 ng/mL for efavirenz has been proposed in the literature, with patients more likely to experience virologic failure below this range and adverse effects above. The current study reports an analysis of virologic outcome between those above, below, or within the reported efavirenz therapeutic range (1000-4000 ng/mL) and within subgroups...
December 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29135895/-comparing-efficacy-and-costs-of-four-facial-fillers-in-hiv-associated-lipodystrophy-a-clinical-trial
#7
Alfonso Vallejo, Angela A Garcia-Ruano, Carmen Pinilla, Michele Castellano, Esther Deleyto, Rosa Perez-Cano
BACKGROUND: The objective was to evaluate and compare safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to Human Immunodeficiency Virus (HIV). METHODS: We conducted a clinical trial including 147 patients suffering from HIV-induced lipoatrophy treated with Sculptra® (poly-L-lactic acid), Radiesse® (calcium hydroxylapatite), Aquamid® (polyacrylamide) or autologous fat. Objective and subjective changes were evaluated during a 24-monthfollow-up...
November 8, 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29135656/frequency-of-monitoring-kidney-function-in-hiv-uninfected-persons-using-daily-oral-tenofovir-disoproxil-fumarate-pre-exposure-prophylaxis
#8
Kenneth K Mugwanya, Jared M Baeten, Christina Wyatt, Nelly R Mugo, Connie L Celum, Allan Ronald, John Kiarie, Elly Katabira, Renee Heffron
BACKGROUND: Wide-scale implementation of oral tenofovir-based pre-exposure prophylaxis (PrEP) for HIV prevention is now policy in many settings. However, the optimal frequency for monitoring kidney function remains uncertain. We investigated the impact of 6-monthly compared to 3-monthly creatinine clearance (CrCl) monitoring on the identification of moderate kidney dysfunction, defined as CrCl <60 mL/min. METHODS: Data were from two prospective daily oral PrEP studies in Kenya and Uganda: the Partners PrEP Study, a randomized safety and efficacy trial of PrEP that conducted 3-monthly CrCl monitoring (n=4404) and the Partners Demonstration Project (n=954), an open-label delivery study of PrEP that used 6-monthly monitoring...
November 6, 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
#9
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/29135574/interferon-free-therapy-for-treating-hcv-in-difficult-to-treat-hiv-coinfected-patients-as-implemented-in-routine-medical-practice
#10
Carlos Mínguez, Miguel García-Deltoro, Juan Flores, Maria-José Galindo, Marta Montero, Sergio Reus, Jorge Carmena, Mar Masiá, Concepción Amador, Enrique Ortega
BACKGROUND/AIMS: Data regarding the use of all-oral direct-acting antivirals (DAA) in HIV/HCV-coinfected patients with advanced liver fibrosis are required, because they are generally under-represented in clinical trials. This study sought to evaluate the use of these drugs in a cohort of coinfected patients, mostly with factors that have previously been recognised as predictors of treatment failure. METHODS: COINFECOVA-2 is an observational, multicenter study conducted in Eastern Spain...
November 10, 2017: AIDS
https://www.readbyqxmd.com/read/29135056/a-systematic-review-of-the-associations-between-hiv-hcv-coinfection-and-biomarkers-of-cardiovascular-disease
#11
REVIEW
Olatokunbo Osibogun, Oluseye Ogunmoroti, Erin D Michos, Erica S Spatz, Babatunde Olubajo, Khurram Nasir, Wasim Maziak
The incidence of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection has been increasing with over 10 million people affected globally. The role biomarkers play as predictors of cardiovascular disease (CVD) risk among coinfected individuals is not well defined. We aimed to systematically review current evidence describing CVD biomarkers among individuals with HIV/HCV coinfection. We searched EMBASE, CINAHL, Google Scholar, PubMed, and Web of Science from inception to June 2017. MeSH terms and keywords were used to identify studies with information on HIV/HCV coinfection and CVD biomarkers (structural, functional, and serological) such as carotid intima-media thickness (CIMT), endothelial markers, C-reactive protein (CRP), homocysteine, and lipids...
November 14, 2017: Reviews in Medical Virology
https://www.readbyqxmd.com/read/29132380/addressing-challenges-in-scaling-up-tb-and-hiv-treatment-integration-in-rural-primary-healthcare-clinics-in-south-africa-suthi-a-cluster-randomized-controlled-trial-protocol
#12
Kogieleum Naidoo, Santhanalakshmi Gengiah, Nonhlanhla Yende-Zuma, Nesri Padayatchi, Pierre Barker, Andrew Nunn, Priashni Subrayen, Salim S Abdool Karim
BACKGROUND: A large and compelling clinical evidence base has shown that integrated TB and HIV services leads to reduction in human immunodeficiency virus (HIV)- and tuberculosis (TB)-associated mortality and morbidity. Despite official policies and guidelines recommending TB and HIV care integration, its poor implementation has resulted in TB and HIV remaining the commonest causes of death in several countries in sub-Saharan Africa, including South Africa. This study aims to reduce mortality due to TB-HIV co-infection through a quality improvement strategy for scaling up of TB and HIV treatment integration in rural primary healthcare clinics in South Africa...
November 13, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/29131878/association-of-brain-structure-changes-and-cognitive-function-with-combination-antiretroviral-therapy-in-hiv-positive-individuals
#13
Ryan Sanford, Lesley K Fellows, Beau M Ances, D Louis Collins
Importance: Despite the introduction of combination antiretroviral therapy (cART), HIV-associated neurocognitive disorders continue to be a problem for treated HIV-positive individuals. The cause of this impairment remains unclear. Objective: To determine if detectable brain changes occur during a 2-year period in HIV-positive individuals who were aviremic and treated with cART. Design, Setting, and Participants: In this longitudinal case-control study, participants underwent neuroimaging and neuropsychological assessment approximately 2 years apart...
November 13, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/29127137/ethics-of-treatment-interruption-trials-in-hiv-cure-research-addressing-the-conundrum-of-risk-benefit-assessment
#14
Gail E Henderson, Holly L Peay, Eugene Kroon, Rosemary Jean Cadigan, Karen Meagher, Thidarat Jupimai, Adam Gilbertson, Jill Fisher, Nuchanart Q Ormsby, Nitiya Chomchey, Nittaya Phanuphak, Jintanat Ananworanich, Stuart Rennie
Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally...
November 10, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/29119934/direct-acting-antivirals-for-hiv-hcv-co-infected-individuals-as-good-as-it-gets
#15
Giuseppe Bruno, Annalisa Saracino
Although HIV/HCV co-infected individuals were historically considered a "difficult to treat" population in the era of Interferon (IFN)-based anti-HCV treatment, the introduction of direct-acting antivirals, characterized by excellent efficacy and good safety profile, has widely revolutionized the HCV treatment scenario. Recent real life studies reported excellent sustained virological response rates in HIV/HCV co-infected subjects, thus confirming data obtained in randomized clinical trials. However, certain issues have recently emerged in this population...
November 8, 2017: Current HIV Research
https://www.readbyqxmd.com/read/29119726/cotrimoxazole-prophylaxis-was-associated-with-enteric-commensal-bacterial-resistance-among-hiv-exposed-infants-in-a-randomized-controlled-trial-botswana
#16
Kathleen M Powis, Sajini Souda, Shahin Lockman, Gbolahan Ajibola, Kara Bennett, Jean Leidner, Michael D Hughes, Sikhulile Moyo, Erik van Widenfelt, Haruna B Jibril, Joseph Makhema, Max Essex, Roger L Shapiro
INTRODUCTION: Despite declining risk of vertical HIV transmission, prophylactic cotrimoxazole (CTX) remains widely used to reduce morbidity and mortality in the event of HIV infection among exposed infants, with an inherent risk of conferring commensal antimicrobial resistance. Using data from a randomized, placebo-controlled trial of infant CTX prophylaxis, we sought to quantify emergence of antibiotic resistance. METHODS: HIV-exposed uninfected infants enrolled in the Botswana Mpepu study were randomized to prophylactic CTX or placebo between 14 and 34 days of life and continued through 15 months...
November 2017: Journal of the International AIDS Society
https://www.readbyqxmd.com/read/29119472/msm-at-highest-risk-for-hiv-acquisition-express-greatest-interest-and-preference-for-injectable-antiretroviral-prep-compared-to-daily-oral-medication
#17
Katie B Biello, Matthew J Mimiaga, Christopher M Santostefano, David S Novak, Kenneth H Mayer
Men who have sex with men (MSM) account for nearly 70% of new HIV diagnoses, with young black MSM at the highest risk for infection in the United States. Pre-exposure prophylaxis (PrEP) can decrease HIV acquisition in at-risk individuals by over 90%. However, therapeutic efficacy requires a daily pill, posing adherence challenges. Experimental modalities, including injectable PrEP given once every 2 months, may improve adherence among those most in need. To assess interest in and preference for injectable PrEP, an online survey was mounted on two popular MSM sexual networking apps...
November 8, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/29118244/isolation-and-characterization-of-antigen-specific-plasmablasts-using-a-novel-flow-cytometry-based-ig-capture-assay
#18
Christopher L Pinder, Sven Kratochvil, Deniz Cizmeci, Luke Muir, Yanping Guo, Robin J Shattock, Paul F McKay
We report the development of a novel flow cytometry-based Ig capture assay (ICA) for the identification and sorting of individual Ab-secreting cells based on their Ag reactivity. The ICA represents a fast and versatile tool for single-cell sorting of peripheral plasmablasts, streamlining subsequent Ab analysis, and cloning. We demonstrate the utility of the assay by isolating Ag-reactive plasmablasts from cryopreserved PBMC obtained from volunteers vaccinated with a recombinant HIV envelope protein. To show the specificity of the ICA, we produced Ag-specific Abs from these cells and subsequently verified their Ag reactivity via ELISA...
November 8, 2017: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/29116028/prenacel-a-mhealth-messaging-system-to-complement-antenatal-care-a-cluster-randomized-trial
#19
Lívia Oliveira-Ciabati, Carolina Sales Vieira, Ana Carolina Arruda Franzon, Domingos Alves, Fabiani Spessoto Zaratini, Giordana Campos Braga, Jazmin Andrea Cifuentes Sanchez, Lívia Pimenta Bonifácio, Magna Santos Andrade, Mariana Fernandes, Silvana Maria Quintana, Suzi Volpato Fabio, Vicky Nogueira Pileggi, Elisabeth Meloni Vieira, João Paulo Souza
BACKGROUND: The aim of this study was to determine whether PRENACEL (a bi-directional, mobile-phone based, short text message service (SMS)) increases the coverage of recommended antenatal care (ANC) practices. METHODS: A parallel, cluster-randomized trial in which 20 public primary Health Care Units (PHCUs) were randomly allocated to the intervention (10 PHCUs) or control (10 PHCUs) group. The study population included pregnant women aged 18 or above with a gestational age of 20 weeks or less...
November 7, 2017: Reproductive Health
https://www.readbyqxmd.com/read/29112963/effectiveness-of-a-combination-strategy-for-linkage-and-retention-in-adult-hiv-care-in-swaziland-the-link4health-cluster-randomized-trial
#20
RANDOMIZED CONTROLLED TRIAL
Margaret L McNairy, Matthew R Lamb, Averie B Gachuhi, Harriet Nuwagaba-Biribonwoha, Sean Burke, Sikhathele Mazibuko, Velephi Okello, Peter Ehrenkranz, Ruben Sahabo, Wafaa M El-Sadr
BACKGROUND: Gaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment. METHODS AND FINDINGS: Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus the standard of care (SOC) on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing...
November 2017: PLoS Medicine
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