6 results on '"Emma M Kileel"'
Search Results
2. Change in body weight and risk of hypertension after switching from efavirenz to dolutegravir in adults living with HIV: evidence from routine care in Johannesburg, South AfricaResearch in context
- Author
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Alana T. Brennan, Cornelius Nattey, Emma M. Kileel, Sydney Rosen, Mhairi Maskew, Andrew C. Stokes, Matthew P. Fox, and Willem D.F. Venter
- Subjects
Integrase strand transfer inhibitors ,Dolutegravir ,Efavirenz ,Weight ,Hypertension ,South Africa ,Medicine (General) ,R5-920 - Abstract
Summary: Background: The integrase strand transfer inhibitor (INSTI) dolutegravir is recommended in World Health Organization guidelines, but is associated with weight gain. We evaluated weight change in patients switching from efavirenz to dolutegravir in first-line antiretroviral therapy (ART) in Johannesburg, South Africa. Methods: We conducted a prospective cohort study of adults (≥16 years) of black African ancestry with HIV who initiated ART between January 2010–December 2020. Patients were propensity score-matched 1:1 (unexposed i.e. remaining on efavirenz: exposed i.e. switched from efavirenz to dolutegravir) on sex, age, months on ART, first ART regimen, haemoglobin, body mass index (BMI), blood pressure, viral load and CD4 count. We used linear regression to assess the effect of switching from efavirenz to dolutegravir on weight change and hypertension 12 months after exposure. Findings: We matched 794 patients switching to dolutegravir to 794 remaining on efavirenz. Exposed patients had a higher mean change in weight (1.78 kg; 95% confidence interval (CI):1.04,2.52 kg) from start of follow-up to 12 months vs. unexposed. We also found a 14.2 percentage point increase (95% CI: 10.6,17.7) in the risk of hypertension in those exposed to dolutegravir vs those that remained on efavirenz. Interpretation: In a real-world population, patients gained more weight and were at higher risk of hypertension after switching from efavirenz to dolutegravir than those remaining on efavirenz. Longer follow-up is needed, however, to determine if INSTI-associated weight gain is associated with changes in non-communicable disease risk over the long-term, or whether weight gain is sustained, as seen in clinical trials. Funding: This study has been made possible by the generous support of the American People and the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID), under the terms of cooperative agreement cooperative Agreement 72067419CA00004. In addition to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1K01MH105320-01A1.
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- 2023
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3. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination
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Kathleen V. Fitch, Emma M. Kileel, Sara E. Looby, Markella V. Zanni, Laura R. Sanchez, Carl J. Fichtenbaum, Edgar T. Overton, Carlos Malvestutto, Judith A. Aberg, Karin L. Klingman, Beverly Alston-Smith, Judith Lavelle, Anne Rancourt, Sharlaa Badal-Faesen, Sandra Wagner Cardoso, Anchalee Avihingsanon, Sandesh Patil, Craig A. Sponseller, Kathleen Melbourne, Heather J. Ribaudo, Katharine Cooper-Arnold, Patrice Desvigne-Nickens, Udo Hoffmann, Pamela S. Douglas, Steven K. Grinspoon, and on behalf of the REPRIEVE Investigators
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hiv ,reprieve ,recruitment ,clinical coordinating center ,cardiovascular disease ,primary prevention ,Infectious and parasitic diseases ,RC109-216 - Abstract
Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino. Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.
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- 2020
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4. Eliciting perspectives of the key study population: An effective strategy to inform advertisement, content and usability of an online survey for a national investigation
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Emma M. Kileel, Corinne Rivard, Kathleen V. Fitch, and Sara E. Looby
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Dietary sweeteners ,Patient-centered approaches ,Study advertisement ,Medicine (General) ,R5-920 - Abstract
This short communication demonstrates how conducting a focus group with members of a proposed study population of interest can help inform the suitability of study interventions and appeal of recruitment strategies prior to study commencement. People living with HIV (PLWH) were recruited to participate in a focus group to elicit feedback on the content and design of an online survey on sweetener knowledge and consumption; and usability of the survey which was ultimately launched nationally. Ten participants (age 55 years, 60% male, 70% non-Caucasian, 60% income
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- 2020
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5. Factors Associated With Systemic Immune Activation Indices in a Global Primary Cardiovascular Disease Prevention Cohort of People With Human Immunodeficiency Virus on Antiretroviral Therapy( )
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Sara E Looby, Amy Kantor, Tricia H Burdo, Judith S Currier, Carl J Fichtenbaum, Edgar T Overton, Judith A Aberg, Carlos D Malvestutto, Gerald S Bloomfield, Kristine M Erlandson, Michelle Cespedes, Esper G Kallas, Mar Masiá, Alice C Thornton, Mandy D Smith, Jacqueline M Flynn, Emma M Kileel, Evelynne Fulda, Kathleen V Fitch, Michael T Lu, Pamela S Douglas, Steven K Grinspoon, Heather J Ribaudo, and Markella V Zanni
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Microbiology (medical) ,Male ,Lipoproteins ,Clinical Trials and Supportive Activities ,Lipopolysaccharide Receptors ,HIV Infections ,Cardiovascular ,Medical and Health Sciences ,Microbiology ,LDL ,Clinical Research ,Major Article ,Humans ,Integrases ,Prevention ,Evaluation of treatments and therapeutic interventions ,HIV ,Nucleosides ,Biological Sciences ,Middle Aged ,Atherosclerosis ,cardiovascular disease risk ,Lipoproteins, LDL ,Heart Disease ,Good Health and Well Being ,Infectious Diseases ,reproductive aging ,Cardiovascular Diseases ,6.1 Pharmaceuticals ,HIV/AIDS ,Reverse Transcriptase Inhibitors ,Female ,women ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,immune activation markers ,Biomarkers - Abstract
Background Among antiretroviral therapy (ART)–treated people with human immunodeficiency virus (PWH), persistent systemic immune activation contributes to atherogenesis atherosclerotic, cardiovascular disease (CVD) events, and mortality. Factors associated with key immune activation indices have not previously been characterized among a global primary CVD prevention cohort of PWH. Methods Leveraging baseline Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) data, we evaluated factors associated with soluble CD14 (sCD14) and oxidized low-density lipoprotein (oxLDL). Results The primary analysis cohort included 4907 participants from 5 global-burden-of-disease regions (38% female, 48% Black, median age 50 years). In fully adjusted models for sCD14, female sex and White race (among those in high-income regions) were associated with higher sCD14 levels, while higher body mass index (BMI) and current use of nucleoside reverse transcriptase inhibitor + integrase strand transfer inhibitor ART were associated with lower sCD14 levels. In fully adjusted models for oxLDL, male sex, residence in high-income regions, White race (among those in high-income regions), and higher BMI were associated with higher oxLDL levels. In a subanalysis cohort of 1396 women with HIV, increased reproductive age was associated with higher sCD14 levels but not with higher oxLDL levels. Conclusions Factors associated with sCD14 and oxLDL, 2 key indices of immune-mediated CVD risk, differ. Future studies will elucidate ways in which medications (eg, statins) and behavioral modifications influence sCD14 and oxLDL and the extent to which dampening of these markers mediates CVD-protective effects. Clinical Trials Registration NCT0234429.
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- 2022
6. Assessment of Obesity and Cardiometabolic Status by Integrase Inhibitor Use in REPRIEVE: A Propensity-Weighted Analysis of a Multinational Primary Cardiovascular Prevention Cohort of People With Human Immunodeficiency Virus
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Emma M Kileel, Janet Lo, Carlos Malvestutto, Kathleen V Fitch, Markella V Zanni, Carl J Fichtenbaum, Edgar T Overton, Nwora Lance Okeke, Princy Kumar, Esau Joao, Judith A Aberg, Esteban Martinez, Judith S Currier, Pamela S Douglas, Heather J Ribaudo, and Steven K Grinspoon
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cardiovascular risk ,obesity ,Prevention ,HIV ,Cardiovascular ,metabolic syndrome ,Major Articles ,Editor's Choice ,Infectious Diseases ,AcademicSubjects/MED00290 ,integrase inhibitors ,Oncology ,Metabolic and endocrine ,Nutrition - Abstract
Background Emerging data demonstrate that the use of integrase inhibitor (INSTI)-based antiretroviral treatment (ART) is associated with increased weight, but the cardiometabolic health consequences of increased weight remains poorly understood. Methods This analysis examined INSTI use (>6 months) at entry among REPRIEVE participants enrolled in High Income and Latin America/Caribbean Global Burden of Disease regions. Primary analyses used linear and logistic regression; secondary analyses used quantile regression to examine differences across the full data distribution. Characteristics of those with and without INSTI use were balanced using inverse probability of treatment weighting. Results Among 4500 REPRIEVE participants, 1848 were on an INSTI-based regimen at entry for an average of 2.1 ± 1.8 years. Integrase inhibitor use (vs no INSTI use) was associated with higher odds of obesity (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.4–1.9) and higher mean body mass index ([BMI] +1.5kg/m2; 95% CI, 1.0–1.9) and waist circumference (+3.6cm; 95% CI, 2.6–4.6). Differences in weight related to INSTI use were greater in the upper tails of the distribution (+3.1kg/m2 [95% CI, 1.9–4.4] at the 90th centile vs +0.7kg/m2 [95% CI, 0.2–1.2] at the 50th centile) and among women and nonwhite participants, with sex and race having an additive effect on BMI. Conversely, INSTI use was not associated with differences in glucose, low-density lipoprotein cholesterol, or higher odds of metabolic syndrome or hypertension. Conclusions Differences in weight and waist circumference associated with INSTI use are (1) not uniform across people with human immunodeficiency virus, (2) greatest among women and nonwhites, and (3) concentrated at the upper tails of weight distribution. These data identify at-risk subgroups for whom long-term cardiovascular disease outcomes should be carefully assessed., INSTI-based regimens are associated with higher weight but not with increased cardiovascular risk for most INSTI users. Differences in weight are not uniform across PWH, and specific subgroups of INSTI users should be monitored for long-term CVD outcomes.
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- 2021
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