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4. 484 Change in pulmonary infections 12 months after elexacaftor/tezacaftor/ivacaftor introduction: Results from the Danish National Cystic Fibrosis Cohort

Author

Jeppesen, M., primary, Jensen-Fangel, S., additional, Leo-Hansen, C., additional, Højte, C., additional, Olsen, M., additional, Wang, M., additional, Bendixen, M., additional, Johansen, H., additional, Bjørn Jensen, C., additional, Pressler, T., additional, Skov, M., additional, Olesen, H., additional, Faurholt-Jepsen, D., additional, Lea Katzenstein, T., additional, and Qvist, T., additional

Published
2022
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8. Afri-Can Forum 2

Author

Mukudu, Hillary, Martinson, Neil, Sartorius, Benn, Coetzee, Jenny, Dietrich, Janan, Mokgatswana, Kgaugelo, Jewkes, Rachel, Gray, Glenda E, Dugas, Marylène, Béhanzin, Luc, Guédou, Fernand A, Gagnon, Marie-Pierre, Alary, Michel, Rutakumwa, Rwamahe, Mbonye, Martin, Kiwanuka, Thadeus, Nakamanya, Sarah, Muhumuza, Richard, Nalukenge, Winfred, Seeley, Janet, Atujuna, Millicent, Wallace, Melissa, Brown, Ben, Bekker, Linda G, Newman, Peter A, Harryparsad, Rushil, Olivier, Abraham J, Jaspan, Heather B, Wilson, Douglas, Mkhize, Nonhlanhla, Morris, Lynn, Cianci, Gianguido, Dinh, Minh, Hope, Thomas, Passmore, Jo-Ann S, Gray, Clive M, Henrick, Bethany M, Yao, Xiao-Dan, Rosenthal, Kenneth L, Drannik, Anna G, Abimiku, Alash’le, Chanzu, Nadia, Mwanda, Walter, Oyugi, Julius, Anzala, Omu, Mbow, Moustapha, Jallow, Sabelle, Thiam, Moussa, Davis, Alberta, Diouf, Assane, Ndour, Cheikh T, Seydi, Moussa, Dieye, Tandakha N, Mboup, Souleymane, Goodier, Martin, Rilley, Eleanor, Jaye, Assan, Omange, RW., Lester, Richard T, Kimani, Joshua, Ball, T. B, Plummer, Francis A, Geraldo, Nassirou, Mastétsé, Ella G, Sossa, Jerôme C, Zannou, Marcel D, Osawe, Sophia, Okpokoro, Evaezi, Okolo, Felicia, Umaru, Stephen, Abimiku, Rebecca, Audu, Sam, Datong, Pam, Nyange, Jacquelyn, Olenja, Joyce, Mutua, Gaudensia, Jaoko, Walter, Omosa-Manyonyi, Gloria, Farah, Bashir, Khaniri, Maureen, Cockcroft, Anne, Tonkin, Kendra, Girish, Indu, Mhati, Puna, Cunningham, Ashley, Andersson, Neil, Indangasi, Jackton, Diphoko, Thabo, Gaseitsiwe, Simani, Maiswe, Victoria, Iketleng, Thato, Maruapula, Dorcas, Bedi, Keabetswe, Moyo, Sikhulile, Musonda, Rosemary, Wainberg, Mark, Makhema, Joseph, Novitsky, Vladimir, Marlink, Richard, Essex, Max, Okoboi, Stephen, Ssali, Livingstone, Kalibala, Sam, Birungi, Josephine, Egessa, Aggrey, Wangisi, Jonathan, Okullu, Lyavala J, Bakanda, Celestin, Obare, Francis, Boer, I. M S, Semvua, Hadija H, Van Den Boogaard, Jossy, Kiwango, Krisanta W, Ngowi, Kennedy M, Nieuwkerk, Pythia T, Aarnoutse, Rob E, Kiwelu, Ireen, Muro, Eva, Kibiki, Gibson S, Datiri, Ruth, Choji, Grace, Audu, Samuel, Fomsgaard, A., Karlsson, I., Jensen, K. J, Jensen, S. S, Leo-Hansen, C., Jespersen, S., Da Silva Té, D., Rodrigues, C. M, Da Silva, Z. J, Janitzek, C. M, Gerstoft, J., Kronborg, G., Daitiri, Ruth, Emily, Nyariki, Joyce, Olenja, Robert, Lorway R, Anzala, Anzala, Viljoen, Katie, Wendoh, Jerome, Kidzeru, Elvis, Karaoz, Ulas, Brodie, Eoin, Botha, Gerrit, Mulder, Nicola, Gray, Clive, Cameron, William, Stintzi, Alain, Jaspan, Heather, Levett, Paul N, Alexander, David, Gulzar, Naveed, Grewal, Prabvir S, Poon, Art F Y, Brumme, Zabrina, Harrigan, P. R, Brooks, James I, Sandstrom, Paul A, Calvez, Stryker, Sanche, Stephen E, Scott, Jamie K, Swartz, Leslie, Kagee, Ashraf, Lesch, Anthea, Kafaar, Zuhayr, De Wet, Anneliese, Smith, Tricia, Cotton, Laura, Hornschuh, Stefanie, Van Der Watt, Martin, Miller, Cari L, Gray, Glenda, Smit, Jenni, Jaggernath, Manjeetha, Ndung’u, Thumbi, Brockman, Mark, Kaida, Angela, Akolo, Maureen, Gelmon, Larry, Chitwa, Michael, Osero, Justus, Marokoane, Nobantu, Kgakole, Leagajang, Maswabi, Boikhutso, Mpofu, Neo, Ansari, Umaira, Nakinobe, Elizabeth, Miiro, George M, Zalwango, Flavia, Nakiyingi-Miiro, Jessica, Kaleebu, Potiano, Semwanga, John R, Nyanzi, Emily, Musoke, Saidat N, Miiro, George, Mbidde, Edward K, Lutalo, Tom, Kaleebu, Pontiano, Handema, Ray, Chianzu, Graham P, Diagne-Gueye, Diabou, Ndiaye, Mame K, Ndiaye, Birahim P, Traore, Ibrahima, Dia, Mamadou C, Thomas, Gilleh, Tour-Kane, Coumba, Mpendo, Juliet, Muyindike, Winnie, Kambugu, Andrew, Sebastian, Hachizovu, Ray, Handema, Mike, Chaponda, Bertin, Kabuya J, Modest, Mulenga, Janha, Omar, Amambua-Ngwa, Alfred, Nwakanma, Davis C, Jespersen, Sanne, Hønge, Bo L, Esbjörnsson, Joakim, Medina, Candida, Da Silva TÉ, David, Correira, Faustino G, Laursen, Alex L, Østergaard, Lars, Andersen, Andreas, Aaby, Peter, Erikstrup, Christian, Wejse, Christian, Dieye, Siry, Sarr, Moussa, Sy, Haby, Mbodj, Helene D, Ndiaye, Marianne, Ndiaye, Amy, Moussa, Seydi, Nyombi, Balthazar M, Shao, Elichilia R, Chilumba, Innocent B, Inyang, Bucky, Izang, Abel, Cole, Chundung, Cameron, Bill, Rosenthal, Kenneth, Seraise, Boitumelo, and Andrea-Marobela, Kerstin

Subjects
Infectious Diseases
Abstract

Table of contents A1 Introduction to the 2nd synchronicity forum of GHRI/CHVI-funded Canadian and African HIV prevention and vaccine teams O1 Voluntary medical male circumcision for prevention of heterosexual transmission of HIV in adult males in Soweto: What do indicators and incidence rate show? Hillary Mukudu, Neil Martinson, Benn Sartorius O2 Developing a peer-led community mobilization program for sex workers in Soweto: HIV risk and demographics Jenny Coetzee, Janan Dietrich, Kgaugelo Mokgatswana, Rachel Jewkes, Glenda E. Gray O3 Salient beliefs about adherence: A qualitative survey conducted as part of the demonstration study on "treatment as prevention" (TasP) and "pre-exposure prophylaxis" (PrEP) among female sex workers (FSWS) in Cotonou, Benin Marylène Dugas, Luc Béhanzin, Fernand A. Guédou, Marie-Pierre Gagnon, Michel Alary O4 Relative perception of risk as a driver of unsafe sexual practices among key populations: Cases of fisherfolk and women and their partners involved in multiple sexual partnerships in Uganda Rwamahe Rutakumwa, Martin Mbonye, Thadeus Kiwanuka, Sarah Nakamanya, Richard Muhumuza, Winfred Nalukenge, Janet Seeley O5 Exploring the acceptability of new biomedical HIV prevention technologies among MSM, adolescents and heterosexual adults in South Africa Millicent Atujuna, Melissa Wallace, Ben Brown, Linda Gail Bekker, Peter A. Newman O6 HIV-susceptible target cells in foreskins after voluntary medical male circumcision in South Africa Rushil Harryparsad, Abraham J. Olivier, Heather B. Jaspan, Douglas Wilson, Janan Dietrich, Neil Martinson, Hillary Mukudu, Nonhlanhla Mkhize, Lynn Morris, Gianguido Cianci, Minh Dinh, Thomas Hope, Jo-Ann S. Passmore, Clive M. Gray O7 HIV-1 proteins activate innate immune responses via TLR2 heterodimers Bethany M. Henrick, Xiao-Dan Yao, Kenneth L. Rosenthal, the INFANT Study Team O8 Characterization of an innate factor in human milk and mechanisms of action against HIV-1 Bethany M. Henrick, Xiao-Dan Yao, Anna G. Drannik, Alash’le Abimiku, Kenneth L. Rosenthal, the INFANT Study Team O9 Secretor status and susceptibility to HIV infections among female sex workers in Nairobi, Kenya Nadia Chanzu, Walter Mwanda, Julius Oyugi, Omu Anzala O10 Natural Killer cell recall responsiveness to Gag-HIV-1 peptides of HIV-1 exposed but uninfected subjects are associated with peripheral CXCR6+ NK cell subsets Moustapha Mbow, Sabelle Jallow, Moussa Thiam, Alberta Davis, Assane Diouf, Cheikh T. Ndour, Moussa Seydi, Tandakha N. Dieye, Souleymane Mboup, Martin Goodier, Eleanor Rilley, Assan Jaye O11 Profiles of resistance: Local innate mucosal immunity to HIV-1 in commercial sex workers Xiao-Dan Yao, RW. Omange, Bethany M. Henrick, Richard T. Lester, Joshua Kimani, T. Blake Ball, Francis A. Plummer, Kenneth L. Rosenthal O12 Early antiretroviral therapy and pre-exposure prophylaxis for HIV prevention among female sex workers in Cotonou, Benin: A demonstration project Luc Béhanzin, Fernand A. Guédou, Nassirou Geraldo, Ella Goma Mastétsé, Jerôme Charles Sossa, Marcel Djimon Zannou, Michel Alary O13 Building capacity for HIV prevention trials: Preliminary data from a Nigerian cohort of HIV exposed sero-negatives (HESN) Sophia Osawe, Evaezi Okpokoro, Felicia Okolo, Stephen Umaru, Rebecca Abimiku, Sam Audu, Pam Datong, Alash’le Abimiku O14 Equipping healthcare professionals with skills required for the conduct of clinical trials in an effort to build capacity. Lessons learned Jacquelyn Nyange, Joyce Olenja, Gaudensia Mutua, Walter Jaoko, Gloria Omosa-Manyonyi, Bashir Farah, Maureen Khaniri, Omu Anzala O15 Educational technology to support active learning for HIV researchers and planners Anne Cockcroft, Kendra Tonkin, Indu Girish, Puna Mhati, Ashley Cunningham, Neil Andersson O16 From Lake Kivu (Rwanda) and Lake Malawi (Tanzania) to the shores of Lake Victoria (Uganda): Strengthening laboratory capacity through Good Clinical Laboratory Practice training Bashir Farah, Jackton Indangasi, Walter Jaoko, Gaudensia Mutua, Maureen Khaniri, Jacquelyn Nyange, Omu Anzala O17 Rilpivirine and etravirine resistance mutations in HIV-1 subtype C infected patients on a non-nucleoside reverse transcriptase inhibitor-based combination antiretroviral therapy in Botswana Thabo Diphoko, Simani Gaseitsiwe, Victoria Maiswe, Thato Iketleng, Dorcas Maruapula, Keabetswe Bedi, Sikhulile Moyo, Rosemary Musonda, Mark Wainberg, Joseph Makhema, Vladimir Novitsky, Richard Marlink, Max Essex O18 From home-based HIV testing to initiation of treatment: The AIDS Support Organization (TASO) Experience with Home-based HIV Counselling and Testing (HBHCT) among Adolescents in Uganda, 2005-2011 Stephen Okoboi, Livingstone Ssali, Sam Kalibala, Josephine Birungi, Aggrey Egessa, Jonathan Wangisi, Lyavala Joanne Okullu, Celestin Bakanda, Francis Obare41 O19 Feasibility study on using real time medication monitoring among HIV infected and Tuberculosis patients in Kilimanjaro, Tanzania I. Marion Sumari-de Boer, Hadija H. Semvua, Jossy van den Boogaard, Krisanta W. Kiwango, Kennedy M. Ngowi, Pythia T. Nieuwkerk, Rob E. Aarnoutse, Ireen Kiwelu, Eva Muro, Gibson S. Kibiki O20 Deaths still among sero-discordant cohort in Nigeria despite Access to treatment Ruth Datiri, Grace Choji, Sophia Osawe, Evaezi Okpokoro, Felicia Okolo, Stephen Umaru, Rebecca Abimiku, Samuel Audu, Pam Datong, Alash’le Abimiku O21 Therapeutic HIV-1 vaccine trials in Denmark and Guinea-Bissau Fomsgaard A, Karlsson I, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, Da Silva Té D, Rodrigues CM, da Silva ZJ, Janitzek CM, Gerstoft J, Kronborg G, the WAPHIR Group O22 Willingness to participate in a HIV vaccine Trial among HIV exposed sero-negative (HESN) persons in Jos, Nigeria Evaezi Okpokoro, Sophia Osawe, Ruth Daitiri, Grace Choji, Stephen Umaru, Felicia Okolo, Pam Datong, Alash'le Abimiku O23 Clinical research volunteers’ perceptions and experiences of screening for enrolment at KAVI-Institute of Clinical Research, Kenya Nyariki Emily, Olenja Joyce, Lorway R. Robert, Anzala Anzala O24 Gut microbiome, HIV-exposure, and vaccine responses in South African infants Katie Viljoen, Jerome Wendoh, Elvis Kidzeru, Ulas Karaoz, Eoin Brodie, Gerrit Botha, Nicola Mulder, Clive Gray, William Cameron, Alain Stintzi, Heather Jaspan, for the INFANT study team O25 Analysis of HIV pol diversity in the concentrated HIV epidemic in Saskatchewan Paul N. Levett, David Alexander, Naveed Gulzar, Prabvir S. Grewal, Art F. Y. Poon, Zabrina Brumme, P. Richard Harrigan, James I. Brooks, Paul A. Sandstrom, Stryker Calvez, Stephen E. Sanche, Jamie K. Scott P1 Evaluating a HIV vaccine research community engagement programme at two HIV prevention research centres in the Western Cape Leslie Swartz, Ashraf Kagee, Anthea Lesch, Zuhayr Kafaar, Anneliese De Wet P2 Validating HIV acquisition risk score using a cohort HIV exposed sero-negative persons in a discordant relationship in Jos, Nigeria, West Africa Evaezi Okpokoro, Sophia Osawe, Ruth Daitiri, Grace Choji, Stephen Umaru, Felicia Okolo, Pam Datong, Alash'le Abimiku P3 Bridging the gap between adults and adolescents and youth adults (AYA) – Employing a youth-centred approach to investigate HIV risk among AYA in Soweto and Durban, South Africa Janan Dietrich, Tricia Smith, Laura Cotton, Stefanie Hornschuh, Martin van der Watt, Cari L. Miller, Glenda Gray, Jenni Smit, Manjeetha Jaggernath, Thumbi Ndung’u, Mark Brockman, Angela Kaida, on behalf of the AYAZAZI study teams P4 Neighbours to sex workers: A key population that has been ignored Maureen Akolo, Joshua Kimani, Prof Larry Gelmon, Michael Chitwa, Justus Osero P5 Young women’s access to structural support programmes in a district of Botswana Anne Cockcroft, Nobantu Marokoane, Leagajang Kgakole, Boikhutso Maswabi, Neo Mpofu, Umaira Ansari, Neil Andersson P6 Voices for action from peri-urban Ugandan students, teachers and parents on HIV/STI prevention: Qualitative research results Nakinobe Elizabeth, Miiro George Mukalazi, Zalwango Flavia, Nakiyingi-Miiro Jessica, Kaleebu Potiano P7 Engaging Social Media as an education tool on the fly: The use of Facebook for HIV and Ebola prevention and awareness amongst adolescents in Uganda John Ross Semwanga, Emily Nyanzi, Saidat Namuli Musoke, Elizabeth Nakinobe, George Miiro, Edward Katongole Mbidde, Tom Lutalo, Pontiano Kaleebu P8 Circulating HIV-1 subtypes among sexual minority populations in Zambia Ray Handema, Graham P. Chianzu P9 The Development of HIV Bio-bank resource management to support clinical trial and Intervention research: WAPHIR experience Moussa Thiam, Diabou Diagne-Gueye, Mame K. Ndiaye, Moustapha Mbow, Birahim P. Ndiaye, Ibrahima Traore, Mamadou C. Dia, Gilleh Thomas, Coumba Tour-Kane, Souleymane Mboup, Assan Jaye P10 Capacity building for clinical trials as a novel approach for scaling up HIV prevention research initiatives in East Africa: achievements and challenges Emily Nyanzi, Edward Katongole Mbidde, Pontiano Kaleebu, Juliet Mpendo, Joshua Kimani, Josephine Birungi, Winnie Muyindike, Andrew Kambugu P11 Community and media perspective of research; an advocacy workshop on HIV prevention research Hachizovu Sebastian, Handema Ray, Chaponda Mike, Kabuya Jean Bertin, Mulenga Modest P12 Development of a quantitative HIV-1 and HIV-2 real time PCR (qRT-PCR) viral load assay Moussa Thiam, Omar Janha, Alberta Davis, Alfred Amambua-Ngwa, Davis C. Nwakanma, Souleymane Mboup, Assan Jaye P13 Differential effects of sex in a West African Cohort of HIV-1, HIV-2 and HIV-1/2 dual infected patients: Men are worse off Sanne Jespersen, Bo Langhoff Hønge, Joakim Esbjörnsson, Candida Medina, David Da Silva TÉ, Faustino Gomes Correira, Alex Lund Laursen, Lars Østergaard, Andreas Andersen, Peter Aaby, Christian Erikstrup, Christian Wejse, for the Bissau HIV Cohort study group P14 HIV-infected adolescents in transition from pediatric to adult HIV care in Dakar, Senegal: sample characteristics and immunological and virological profiles Siry Dieye, Moussa Sarr, Haby Sy, Helene D Mbodj, Marianne Ndiaye, Amy Ndiaye, Seydi Moussa, Assan Jaye, Souleymane Mboup100 P15 Molecular characterization of vertically transmitted HIV-1 among children born to HIV-1 seropositive mothers in Northern Tanzania Balthazar M. Nyombi, Elichilia R. Shao, Innocent B. Chilumba, Sikhulile Moyo, Simani Gaseitsiwe, Rosemary Musonda P16 Breast-fed HIV-1 exposed infants play catch up. A preliminary report Pam Datong, Bucky Inyang, Sophia Osawe, Abel Izang, Chundung Cole, Felicia Okolo, Bill Cameron, Kenneth Rosenthal, Clive Gray, Heather Jaspan, Alash’le Abimiku, the INFANT study team P17 The frequency of N348I mutation in patient failing combination antiretroviral treatment In Botswana Boitumelo Seraise, Kerstin Andrea-Marobela, Sikhulile Moyo, Rosemary Musonda, Joseph Makhema, Max Essex, Simani Gaseitsiwe

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9. Real-world data confirm elexacftor/tezacaftor/ivacaftor modulators halves sweat chloride concentration in eligible people with cystic fibrosis.

Author

Bryrup T, Faurholt-Jepsen D, Pressler T, Henriksen EH, Leo-Hansen C, Nielsen BU, Højte C, Mathiesen IHM, Katzenstein TL, Jeppesen M, Jensen-Fangel S, Olesen HV, Skov M, Qvist T, and Olsen MF

Subjects
Humans, Male, Female, Adult, Adolescent, Young Adult, Drug Combinations, Child, Pyrazoles therapeutic use, Denmark, Pyridines therapeutic use, Pyridines administration & dosage, Middle Aged, Child, Preschool, Genotype, Homozygote, Chloride Channel Agonists therapeutic use, Pyrrolidines, Cystic Fibrosis drug therapy, Cystic Fibrosis metabolism, Cystic Fibrosis genetics, Sweat chemistry, Sweat metabolism, Chlorides analysis, Chlorides metabolism, Benzodioxoles therapeutic use, Indoles therapeutic use, Cystic Fibrosis Transmembrane Conductance Regulator genetics, Cystic Fibrosis Transmembrane Conductance Regulator metabolism, Aminophenols therapeutic use, Quinolones therapeutic use
Abstract

Sweat chloride concentration, a diagnostic feature in cystic fibrosis (CF), reflects CF transmembrane conductance regulator (CFTR) activity. CFTR modulator therapies, especially elexacaftor/tezacaftor/ivacaftor (ETI), has improved CF outcomes. We report nationwide, real-world data on sweat chloride concentration in people with CF (pwCF) with and without modulator therapies. All Danish pwCF with a minimum of one F508del allele were included. Sweat chloride measurements were stratified by genotype and modulator treatment. Differences were assessed using mixed-effects models. We included 977 sweat chloride measurements from 430 pwCF, 71% of which were F508del homozygous. Heterozygous and homozygous ETI-treated pwCF had an estimated mean sweat chloride concentration of 43 mmol/L (95% confidence interval: 39; 48) and 43 mmol/L (39; 47), respectively-48% and 59% lower than those without treatment. High variation in concentrations remained regardless of treatment status. Despite ETI treatment, 27% heterozygous and 23% homozygous pwCF had elevated concentrations (≥60 mmol/L). These real-world data confirm a substantial decrease in sweat chloride concentration during modulator treatment, especially ETI, where mean concentrations halved. However, large variation remained, including persistently high concentrations. These findings emphasize the potential of sweat chloride concentration as a treatment response biomarker and the need to explore its heterogeneity and relationship with clinical outcomes., (© 2024 The Author(s). APMIS published by John Wiley & Sons Ltd on behalf of Scandinavian Societies for Pathology, Medical Microbiology and Immunology.)

Published
2024
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10. Change in exercise capacity measured by Cardio-pulmonary Exercise Testing (CPET) in Danish people with cystic fibrosis after initiation of treatment with Lumacaftor/Ivacaftor and Tezacaftor/Ivacaftor.

Author

Rysgaard UK, Pedersen CL, Jensen JH, Sørensen L, Philipsen LKD, Leo-Hansen C, and Olesen HV

Subjects
Aminophenols therapeutic use, Aminopyridines therapeutic use, Bacterial Toxins, Benzodioxoles therapeutic use, Denmark, Drug Combinations, Exercise Test, Exercise Tolerance, Humans, Indoles, Mutation, Prospective Studies, Quinolones, Cystic Fibrosis diagnosis, Cystic Fibrosis drug therapy, Cystic Fibrosis genetics, Cystic Fibrosis Transmembrane Conductance Regulator genetics
Abstract

Background: Since 2015, when the first cystic fibrosis transmembrane conductance regulator (CFTR) modulators were approved for people with cystic fibrosis (CF) homozygous for F508del-CFTR, studies have shown improved lung function after initiation of the treatment and patients experience improved physical capacity. The aim of this study was to investigate change in exercise capacity after initiation of Lumacaftor/Ivacaftor and Tezacaftor/Ivacaftor treatment (LUM/IVA, TEZ/IVA)., Methods: We performed a single group prospective observational cohort study with follow-up at six and 12 months. The study examined change in exercise capacity in people with CF initiating treatment with LUM/IVA and TEZ/IVA, measured by cardio-pulmonary exercise testing (CPET). Inclusion criteria were people with CF homozygous for F508del-CFTR aged 12 years or older eligible for LUM/IVA and TEZ/IVA treatment from June 2017 until June 2019. Primary outcomes were change in VO 2peak and maximal workload. Secondary outcomes were change in muscle strength, muscle power and body composition in a subgroup of the study population., Results: A total of 91 patients were included in the analysis. The mean change in VO 2peak and VO 2peak divided by body weight from baseline to 12-months follow-up was 145.7 (91.2;200.2) ml/min and 1.07 (95% CI 0.19;1.95) ml/min/kg, respectively. The mean change in maximal workload between baseline and 12 months was 14.2 Watt (95% CI 9.1;19.2). All improvements in exercise capacity were statistically significant., Conclusions: Patients in this study improved their exercise capacity by a statistically significant increase in VO 2peak and maximal workload 12 months after initiation of treatment with LUM/IVA and TEZ/IVA., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.)

Published
2022
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11. Glucometabolic changes influence hospitalization and outcome in patients with COVID-19: An observational cohort study.

Author

Clausen CL, Leo-Hansen C, Faurholt-Jepsen D, Krogh-Madsen R, Ritz C, Kirk O, Jørgensen HL, Benfield T, Almdal TP, and Snorgaard O

Subjects
Blood Glucose metabolism, Hospitalization, Humans, Retrospective Studies, COVID-19 epidemiology, Diabetes Mellitus diagnosis, Hyperglycemia
Abstract

Aims: The aim was to report the prevalence of diabetes status in patients hospitalized with COVID-19 and assess the association between the glucometabolic status at admission and 90-day mortality., Methods: Consecutive patients hospitalized with COVID-19 were included in the study. All participants included had an HbA 1c measurement 60 days prior to or within 7 days after admission. We studied the association between diabetes status, the glycemic gap (difference between admission and habitual status), admission plasma-glucose, and mortality using Cox proportional hazards regression., Results: Of 674 patients included, 114 (17%) had normal glucose level, 287 (43%) had pre-diabetes, 74 (11%) had new-onset, and 199 (30%) had diagnosed diabetes. No association between diabetes status, plasma-glucose at admission, and mortality was found. Compared to the 2nd quartile (reference) of glycemic-gap, those with the highest glycemic gap had increased mortality (3rd (HR 2.38 [1.29-4.38], p = 0.005) and 4th quartile (HR 2.48 [1.37-4.52], p = 0.002)., Conclusion: Abnormal glucose metabolism was highly prevalent among patients hospitalized with COVID-19. Diabetes status per se or admission plasma-glucose was not associated with a poorer outcome. However, a high glycemic gap was associated with increased risk of mortality, suggesting that, irrespective of diabetes status, glycemic stress serves as an important prognostic marker for mortality., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Published
2022
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12. [Symptomatic SARS-CoV-2 reinfection in an otherwise healthy person].

Author

Leo-Hansen C, Roed C, and Katzenstein T

Subjects
Health Personnel, Health Status, Humans, Reinfection, COVID-19, SARS-CoV-2
Abstract

This is a case report of a young healthcare worker with a mild case of COVID-19 during the first wave in 2020 with no initial triggering of antibody response. The second episode of symptomatic infection of the patient with symptoms of moderate COVID-19, occurred eight months later in the beginning of the second surge in Denmark. It is the first reported case of symptomatic SARS-CoV-2 reinfection in Denmark, and it illustrates the possibility of reinfection with a more severe course of COVID-19 after an initial natural infection also among young immunocompetent individuals.

Published
2021

13. Therapeutic vaccination using cationic liposome-adjuvanted HIV type 1 peptides representing HLA-supertype-restricted subdominant T cell epitopes: safety, immunogenicity, and feasibility in Guinea-Bissau.

Author

Román VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, da Silva Té D, Rodrigues CM, Janitzek CM, Vinner L, Katzenstein TL, Andersen P, Kromann I, Andreasen LV, Karlsson I, and Fomsgaard A

Subjects
AIDS Vaccines immunology, Adjuvants, Immunologic administration & dosage, Adult, Antigens, Viral immunology, CD4 Lymphocyte Count, Enzyme-Linked Immunospot Assay, Epitopes, T-Lymphocyte immunology, Epitopes, T-Lymphocyte therapeutic use, Female, Guinea-Bissau, Humans, Interferon-gamma metabolism, Liposomes administration & dosage, Male, Middle Aged, Phosphoproteins immunology, Viral Load, Young Adult, AIDS Vaccines adverse effects, AIDS Vaccines therapeutic use, Antigens, Viral therapeutic use, HIV Infections therapy, HIV-1 immunology, Immunotherapy adverse effects, Immunotherapy methods
Abstract

We have designed a therapeutic HIV-1 vaccine concept based on peptides together with the adjuvant CAF01. Peptides represented 15 HLA-supertype-restricted subdominant and conserved CD8 T cell epitopes and three CD4 T-helper cell epitopes. In this phase I clinical trial, safety and immunogenicity were assessed in untreated HIV-1-infected individuals in Guinea-Bissau, West Africa. Twenty-three HIV-1-infected individuals were randomized to receive placebo (n=5) or vaccine (n=18). Safety was appraised by clinical follow-up combined with monitoring of biochemistry, hematology, CD4 T cell counts, and HIV-1 viral loads. T cell immunogenicity was monitored longitudinally by interferon (IFN)-γ ELISpot. New vaccine-specific T cell responses were induced in 6/14 vaccinees for whom ELISpot data were valid. CD4 T cell counts and viral loads were stable. The study shows that therapeutic immunization is feasible and safe in Guinea-Bissau and that it is possible to redirect T cell immunity with CAF01-adjuvanted HIV-1 peptide vaccine during untreated HIV-1 infection in some patients. However, relatively few preexisting and vaccine-induced HIV-1 T cell responses to CD8 T cell epitopes were detected against HIV-1 using IFN-γ ELISpot in this chronically infected African population.

Published
2013
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14. Determinants of vitamin a deficiency in children between 6 months and 2 years of age in Guinea-Bissau.

Author

Danneskiold-Samsøe N, Fisker AB, Jørgensen MJ, Ravn H, Andersen A, Balde ID, Leo-Hansen C, Rodrigues A, Aaby P, and Benn CS

Subjects
Child, Preschool, Ethnicity statistics & numerical data, Female, Guinea-Bissau epidemiology, Humans, Infant, Male, Risk Factors, Seasons, Vaccination statistics & numerical data, Vitamin A Deficiency ethnology, Rural Health statistics & numerical data, Vitamin A Deficiency epidemiology
Abstract

Background: The World Health Organization (WHO) classifies Guinea-Bissau as having severe vitamin A deficiency (VAD). To date, no national survey has been conducted. We assessed vitamin A status among children in rural Guinea-Bissau to assess status and identify risk factors for VAD., Methods: In a vitamin A supplementation trial in rural Guinea-Bissau, children aged 6 months to 2 years who were missing one or more vaccines were enrolled, vaccinated and randomized to vitamin A or placebo. Provided consent, a dried blood spot (DBS) sample was obtained from a subgroup of participants prior to supplementation. Vitamin A status and current infection was assessed by an ELISA measuring retinol-binding protein (RBP) and C-reactive protein (CRP). VAD was defined as RBP concentrations equivalent to plasma retinol <0.7 μmol/L; infection was defined as CRP >5 ml/L. In Poisson regression models providing prevalence ratios (PR), we investigated putative risk factors for VAD including sex, age, child factors, maternal factors, season (rainy: June-November; dry: December-May), geography, and use of health services., Results: Based on DBS from 1102 children, the VAD prevalence was 65.7% (95% confidence interval 62.9-68.5), 11% higher than the WHO estimate of 54.7% (9.9-93.0). If children with infection were excluded, the prevalence was 60.2% (56.7-63.7). In the age group 9-11 months, there was no difference in prevalence of VAD among children who had received previous vaccines in a timely fashion and those who had not. Controlled for infection and other determinants of VAD, the prevalence of VAD was 1.64 (1.49-1.81) times higher in the rainy season compared to the dry, and varied up to 2-fold between ethnic groups and regions. Compared with having an inactivated vaccine as the most recent vaccine, having a live vaccine as the most recent vaccination was associated with lower prevalence of VAD (PR=0.84 (0.74-0.96))., Conclusions: The prevalence of VAD was high in rural Guinea-Bissau. VAD varied significantly with season, ethnicity, region, and vaccination status., Trial Registration: Clinicaltrials.gov NCT00514891.

Published
2013
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15. Clade A HIV-1 Gag-specific T cell responses are frequent but do not correlate with viral loads in a cohort of treatment-naive HIV-infected individuals living in Guinea-Bissau.

Author

Jensen KJ, Gómez Román VR, Jensen SS, Leo-Hansen C, Karlsson I, Katzenstein TL, Rodrigues CM, Jespersen S, Janitzek CM, Té Dda S, Hayes P, and Fomsgaard A

Subjects
CD4 Lymphocyte Count, Genotype, Guinea-Bissau, HIV-1 classification, HIV-1 genetics, HIV-1 isolation & purification, Humans, Interferon-gamma metabolism, HIV Infections immunology, HIV Infections virology, HIV-1 immunology, T-Lymphocytes immunology, Viral Load, gag Gene Products, Human Immunodeficiency Virus immunology
Published
2012
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16. Assessment of HIV-1 patient recruitability in the Republic of Guinea-Bissau using African versus North American hematology and biochemistry reference intervals.

Author

Gómez Román VR, Jensen SS, Leo-Hansen C, Jensen KJ, Janitzek CM, Rodrigues CM, Jespersen S, Katzenstein TL, Té Dda S, and Fomsgaard A

Subjects
Adult, Female, Guidelines as Topic, Guinea-Bissau, Humans, Male, Middle Aged, North America, Biomedical Research methods, Clinical Trials as Topic, HIV Infections pathology, HIV Infections physiopathology, Patient Selection, Reference Values
Abstract

Hematology and biochemistry reference intervals have been derived from healthy, HIV-negative populations to guide clinical trials worldwide. However, it is less clear how such values may be applied to clinical trials involving HIV-infected individuals. We show that contradictory interpretations about patient recruitability are reached when applying African versus North American reference intervals to an HIV-1 cohort in Guinea-Bissau. These observations underscore the need to question non-African guidelines in the context of HIV intervention clinical trials in Africa.

Published
2012
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