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1. Long-term efficacy and safety of a treatment strategy for HIV infection using protease inhibitor monotherapy: 8-year routine clinical care follow-up from a randomised, controlled, open-label pragmatic trial (PIVOT)

Author

Fisher, Martin, Clarke, Amanda, Hadley, Wendy, Stacey, David, Johnson, Margaret, Byrne, Pat, Williams, Ian, De Esteban, Nahum, Pellegrino, Pierre, Haddow, Lewis, Arenas-Pinto, Alejandro, Orkin, Chloe, Hand, James, De Souza, Carl, Murthen, Lisa, Crawford-Jones, Andrew, Chen, Fabian, Wilson, Ruth, Green, Elizabeth, Masterson, John, Lee, Vincent, Patel, Kamlesh, Howe, Rebecca, Winston, Alan, Mullaney, Scott, Gompels, Mark, Jennings, Louise, Beeching, Nicholas, Tamaklo, Rebecca, Fox, Julie, Teague, Alistair, Jendrulek, Isabelle, Tiraboschi, Juan Manuel, Wilkins, Ed, Clowes, Yvonne, Thompson, Andrew, Brook, Gary, Trivedi, Manoj, Aderogba, Kazeem, Jones, Martin, DeBurgh-Thomas, Andrew, Jones, Liz, Reeves, Iain, Mguni, Sifiso, Chadwick, David, Spence, Pauline, Nkhoma, Nellie, Warwick, Zoe, Price, Suzanne, Read, Sally, Herieka, Elbushra, Walker, James, Woodward, Ruth, Day, John, Hilton, Laura, Harinda, Veerakathy, Blackman, Helen, Hay, Phillip, Mejewska, Wendy, Okolo, Olanike, Ong, Edmund, Martin, Karen, Munro, Lee, Dockrell, David, Smart, Lynne, Ainsworth, Jonathan, Waters, Anele, Kegg, Stephen, McNamara, Sara, Taylor, Steve, Gilleran, Gerry, Gazzard, Brian, Rowlands, Jane, Allan, Sris, Sandhu, Rumun, O'Farrell, Nigel, Quaid, Sheena, Martin, Fabiola, Bennett, Caroline, Kapembwa, Moses, Minton, Jane, Calderwood, James, Post, Frank, Campbell, Lucy, Wandolo, Emily, Palfreeman, Adrian, Mashonganyika, Linda, Balachandran, Thambiah, Kakowa, Memory, O'Connell, Rebecca, Tanawa, Cheryl, Jebakumar, Sinna, Hagger, Lesley, Quah, Say, McKernan, Sinead, Lacey, Charles, Douglas, Sarah, Russell-Sharpe, Sarah, Brewer, Christine, Leen, Clifford, Morris, Sheila, Obeyesekera, Sharmin, Williams, Shirley, David, Nelson, Roberts, Mark, Wollaston, Julie, Paton, Nicholas, Stöhr, Wolfgang, Scott, Karen, Dunn, David, Beaumont, Emma, Fleck, Sue, Hall, Mark, Hennings, Susie, Kummeling, Ischa, Martins, Sara, Owen-Powell, Ellen, Sanders, Karen, van Hooff, Fionna, Vivas, Livia, White, Ellen, Angus, Brian, Freedman, Andrew, Cromerty, Ben, Mercey, Danielle, Fidler, Sarah, Torok, Estee, Babiker, Abdel, Peto, Tim, Lalloo, David, Phillips, Andrew, James, Robert, Paton, Nicholas I., and Dunn, David T.

Published
2024
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2. Effect of second booster vaccinations and prior infection against SARS-CoV-2 in the UK SIREN healthcare worker cohort

Author

Lewis, Tracy, Bain, Steve, Thomas, Rebeccah, Geen, John, Pothecary, Carla, Cutler, Sean, Northfield, John, Price, Cathy, Tomlinson, Johanne, Knight, Sarah, Macnaughton, Emily, Watson, Ekaterina, Lazarus, Rajeka, Sinclair, Aaran, Galliford, Joanne, Masunda, Bridgett, Mahungu, Tabitha, Rodger, Alison, Hanison, Esther, Warren, Simon, Jain, Swati, Mirfenderesky, Mariyam, Mahabir, Natasha, Pritchard-Jones, Rowan, Wycherley, Diane, Gabriel, Claire, Matovu, Elijah, Bakker, Philippa, Guha, Simantee, Gormley, S., Pethick, James, Butt, Georgina, Pepper, Stacey, Bedford, Luke, Ridley, Paul, Democratis, Jane, Meda, Manjula, Chawla, Anu, Westwell, Fran, Kalakonda, Nagesh, Khanduri, Sheena, Doel, Allison, Pai, Sumita, Hacon, Christian, Nwaka, Davis, Moro, Veronica Mendez, Moody, A., Auckland, Cressida, Prince, Stephanie, de Silva, Thushan, Shulver, Helen, Shah, A., Jones, C., Subhro-Osuji, Banerjee, Houston, Angela, Planche, Tim, Booth, Martin, Duff, Christopher, Aeron-Thomas, Jonnie, Chaudhuri, Ray, Hilton, David, Jory, Hannah, Al-Khafaji, Zehra'a, Kemsley, Philippa, Longfellow, Ruth, Boss, David, Brake, Simon, Coke, Louise, Elumogo, Ngozi, Latham, Scott, Subudhi, Chinari, Hoad, Ina, Thomas, Claire, Chitalia, Nihil, Edmunds, Tracy, Ashby, Helen, Elliott, John, Wilkinson, Beverley, Rand, Abby, Thompson, Catherine, Agwuh, K., Grice, Anna, Moran, Kelly, Waykar, Vijayendra, Lester, Yvonne, Sach, Lauren, Court, Kathryn, White, Nikki, Favager, Clair, Holliday, Kyra, Harwood, Jayne, Payne, Brendan, Burns, Karen, Fothergill, Lynda, Arenas-Pinto, Alejandro, Severn, Abigail, Brown, Kerryanne, Gray, Katherine, Dare, Jane, Zheng, Qi, Hollinshead, Kathryn, Shorten, Robert, Roebuck, Alun, Holmes, Christopher, Wiselka, Martin, Faris, Barzo, Marsh, Liane, McAdam, Clare, Ditchfield, Lisa, Qazzafi, Zaman, Boyd, G., Wong, N., Brand, Sarah, Squires, Jack, Ashcroft, John, Rosario, Ismaelette Del, Howard, Joanne, Ward, Emma, Harrison, Gemma, Morgan, Joely, Corless, Claire, Penn, Ruth, Wong, Nick, Bagary, Manny, Starkova, Nadezda, Beekes, Mandy, Carnahan, Mandy, Khan, Shivani, Mackay, Shekoo, Lewis, Keneisha, Pickard, Graham, Dawson, Joy, Finlayson, Lauren, Cameron, Euan, Todd, Anne, Fagegaltier, Sebastien, Mavin, Sally, Cochrane, Alexandra, Gibson, Andrew, Donaldson, Sam, Templeton, Kate, Malcolm, Martin, Smith, Beth, Dhasmana, Devesh, Fowler, Susan, Ho, Antonia, Murphy, Michael, Beith, Claire, Patel, Manish, Boyd, Elizabeth, Irvine, Val, Grant, Alison, Temple-Purcell, Rebecca, Loughrey, Clodagh, Hanna, Elinor, Johnston, Frances, Boulos, Angel, Thompson, Fiona, Protaschik, Yuri, Regan, Susan, Donaghy, Tracy, O'Kane, Maurice, Akinbami, Omolola, Barbero, Paola, Brooks, Tim, Chand, Meera, Insalata, Ferdinando, Joshi, Palak, O'Connell, Anne-Marie, Ramsay, Mary, Saei, Ayoub, Zambon, Maria, Linley, Ezra, Tonge, Simon, Adaji, Enemona, Adebiyi, Omoyeni, Andrews, Nick, Conneely, Joanna, Conneely, Paul, Dunne, Angela, Dyer, Simone, Emmett, Hannah, Hettiarachchi, Nipunadi, Kapirial, Nishanthan, Khawam, Jameel, Monk, Edward, Russell, Sophie, Taylor-Kerr, Andrew, Timeyin, Jean, D'Arcangelo, Silvia, Rowe, Cathy, Semper, Amanda, Gallagher, Eileen, Kyffin, Robert, Cromey, Lisa, Areghan, Desmond, Bishop, Jennifer, Dembinsky, Melanie, Dobbie, Laura, Evans, Josie, Goldberg, David, Haahr, Lynne, Jorgenson, Annelysse, Matuluko, Ayodeji, Naismith, Laura, Nuryunarsih, Desy, Olaoye, Alexander, Plank, Caitlin, Price, Lesley, Sergenson, Nicole, Stewart, Sally, Telfer, Andrew, Weir, Jennifer, De Lacy, Ellen, Ellis, Yvette, Froude, Susannah, Stevens, Guy, Tyson, Linda, Dunachie, Susanna, Klenerman, Paul, Duncan, Chris, Payne, Rebecca, Turtle, Lance, Richter, Alex, De Silva, Thushan, Barnes, Eleanor, Wootton, Daniel, Galgut, Oliver, Heeney, Jonathan, Baxendale, Helen, Castillo-Olivares, Javier, Beale, Rupert, Carr, Edward, Barclay, Wendy, Moshe, Maya, Palmarini, Massimo, Willett, Brian, Baillie, John Kenneth, Evans, Jennie, Aquino, Erika, Kirwan, Peter D., Hall, Victoria J., Foulkes, Sarah, Otter, Ashley D., Munro, Katie, Sparkes, Dominic, Howells, Anna, Platt, Naomi, Broad, Jonathan, Crossman, David, Norman, Chris, Corrigan, Diane, Jackson, Christopher H., Cole, Michelle, Brown, Colin S., Atti, Ana, Islam, Jasmin, Presanis, Anne M., Charlett, Andre, De Angelis, Daniela, and Hopkins, Susan

Published
2024
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3. Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV

Author

Moore, Amelia E.B., Burns, James E., Sally, Deirdre, Milinkovic, Ana, Krokos, Georgios, John, Joemon, Rookyard, Christopher, Borca, Alessandro, Pool, Erica R.M., Tostevin, Anna, Harman, Alyss, Dulnoan, Dwight S., Gilson, Richard, Arenas-Pinto, Alejandro, Cook, Gary J.R., Saunders, John, Dunn, David, Blake, Glen M., and Pett, Sarah L.

Published
2024
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4. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford

Published
2023
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5. No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

Author

Wright, Edwina J, Grund, Birgit, Robertson, Kevin R, Cysique, Lucette, Brew, Bruce J, Collins, Gary L, Poehlman-Roediger, Mollie, Vjecha, Michael J, Penalva de Oliveira, Augusto César, Standridge, Barbara, Carey, Cate, Avihingsanon, Anchalee, Florence, Eric, Lundgren, Jens D, Arenas-Pinto, Alejandro, Mueller, Nicolas J, Winston, Alan, Nsubuga, Moses S, Lal, Luxshimi, and Price, Richard W

Subjects
Infectious Diseases, HIV/AIDS, Clinical Research, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, AIDS Dementia Complex, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Female, HIV Infections, Humans, Longitudinal Studies, Male, Secondary Prevention, Treatment Outcome, antiretroviral treatment, central nervous system, HAND, HIV, neurocognitive impairment, INSIGHT START Neurology Substudy Group, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology
Abstract

ObjectiveTo compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 cells/μl.DesignRandomized trial.MethodsThe START parent study randomized participants to commence immediate versus deferred ART until CD4 less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models.ResultsThe 592 participants had a median age of 34 years; median baseline CD4 count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P

Published
2018

7. Effect of second booster vaccinations and prior infection against SARS-CoV-2 in the UK SIREN healthcare worker cohort

Author

Kirwan, Peter D., primary, Hall, Victoria J., additional, Foulkes, Sarah, additional, Otter, Ashley D., additional, Munro, Katie, additional, Sparkes, Dominic, additional, Howells, Anna, additional, Platt, Naomi, additional, Broad, Jonathan, additional, Crossman, David, additional, Norman, Chris, additional, Corrigan, Diane, additional, Jackson, Christopher H., additional, Cole, Michelle, additional, Brown, Colin S., additional, Atti, Ana, additional, Islam, Jasmin, additional, Presanis, Anne M., additional, Charlett, Andre, additional, De Angelis, Daniela, additional, Hopkins, Susan, additional, Lewis, Tracy, additional, Bain, Steve, additional, Thomas, Rebeccah, additional, Geen, John, additional, Pothecary, Carla, additional, Cutler, Sean, additional, Northfield, John, additional, Price, Cathy, additional, Tomlinson, Johanne, additional, Knight, Sarah, additional, Macnaughton, Emily, additional, Watson, Ekaterina, additional, Lazarus, Rajeka, additional, Sinclair, Aaran, additional, Galliford, Joanne, additional, Masunda, Bridgett, additional, Mahungu, Tabitha, additional, Rodger, Alison, additional, Hanison, Esther, additional, Warren, Simon, additional, Jain, Swati, additional, Mirfenderesky, Mariyam, additional, Mahabir, Natasha, additional, Pritchard-Jones, Rowan, additional, Wycherley, Diane, additional, Gabriel, Claire, additional, Matovu, Elijah, additional, Bakker, Philippa, additional, Guha, Simantee, additional, Gormley, S., additional, Pethick, James, additional, Butt, Georgina, additional, Pepper, Stacey, additional, Bedford, Luke, additional, Ridley, Paul, additional, Democratis, Jane, additional, Meda, Manjula, additional, Chawla, Anu, additional, Westwell, Fran, additional, Kalakonda, Nagesh, additional, Khanduri, Sheena, additional, Doel, Allison, additional, Pai, Sumita, additional, Hacon, Christian, additional, Nwaka, Davis, additional, Moro, Veronica Mendez, additional, Moody, A., additional, Auckland, Cressida, additional, Prince, Stephanie, additional, de Silva, Thushan, additional, Shulver, Helen, additional, Shah, A., additional, Jones, C., additional, Subhro-Osuji, Banerjee, additional, Houston, Angela, additional, Planche, Tim, additional, Booth, Martin, additional, Duff, Christopher, additional, Aeron-Thomas, Jonnie, additional, Chaudhuri, Ray, additional, Hilton, David, additional, Jory, Hannah, additional, Al-Khafaji, Zehra'a, additional, Kemsley, Philippa, additional, Longfellow, Ruth, additional, Boss, David, additional, Brake, Simon, additional, Coke, Louise, additional, Elumogo, Ngozi, additional, Latham, Scott, additional, Subudhi, Chinari, additional, Hoad, Ina, additional, Thomas, Claire, additional, Chitalia, Nihil, additional, Edmunds, Tracy, additional, Ashby, Helen, additional, Elliott, John, additional, Wilkinson, Beverley, additional, Rand, Abby, additional, Thompson, Catherine, additional, Agwuh, K., additional, Grice, Anna, additional, Moran, Kelly, additional, Waykar, Vijayendra, additional, Lester, Yvonne, additional, Sach, Lauren, additional, Court, Kathryn, additional, White, Nikki, additional, Favager, Clair, additional, Holliday, Kyra, additional, Harwood, Jayne, additional, Payne, Brendan, additional, Burns, Karen, additional, Fothergill, Lynda, additional, Arenas-Pinto, Alejandro, additional, Severn, Abigail, additional, Brown, Kerryanne, additional, Gray, Katherine, additional, Dare, Jane, additional, Zheng, Qi, additional, Hollinshead, Kathryn, additional, Shorten, Robert, additional, Roebuck, Alun, additional, Holmes, Christopher, additional, Wiselka, Martin, additional, Faris, Barzo, additional, Marsh, Liane, additional, McAdam, Clare, additional, Ditchfield, Lisa, additional, Qazzafi, Zaman, additional, Boyd, G., additional, Wong, N., additional, Brand, Sarah, additional, Squires, Jack, additional, Ashcroft, John, additional, Rosario, Ismaelette Del, additional, Howard, Joanne, additional, Ward, Emma, additional, Harrison, Gemma, additional, Morgan, Joely, additional, Corless, Claire, additional, Penn, Ruth, additional, Wong, Nick, additional, Bagary, Manny, additional, Starkova, Nadezda, additional, Beekes, Mandy, additional, Carnahan, Mandy, additional, Khan, Shivani, additional, Mackay, Shekoo, additional, Lewis, Keneisha, additional, Pickard, Graham, additional, Dawson, Joy, additional, Finlayson, Lauren, additional, Cameron, Euan, additional, Todd, Anne, additional, Fagegaltier, Sebastien, additional, Mavin, Sally, additional, Cochrane, Alexandra, additional, Gibson, Andrew, additional, Donaldson, Sam, additional, Templeton, Kate, additional, Malcolm, Martin, additional, Smith, Beth, additional, Dhasmana, Devesh, additional, Fowler, Susan, additional, Ho, Antonia, additional, Murphy, Michael, additional, Beith, Claire, additional, Patel, Manish, additional, Boyd, Elizabeth, additional, Irvine, Val, additional, Grant, Alison, additional, Temple-Purcell, Rebecca, additional, Loughrey, Clodagh, additional, Hanna, Elinor, additional, Johnston, Frances, additional, Boulos, Angel, additional, Thompson, Fiona, additional, Protaschik, Yuri, additional, Regan, Susan, additional, Donaghy, Tracy, additional, O'Kane, Maurice, additional, Akinbami, Omolola, additional, Barbero, Paola, additional, Brooks, Tim, additional, Chand, Meera, additional, Insalata, Ferdinando, additional, Joshi, Palak, additional, O'Connell, Anne-Marie, additional, Ramsay, Mary, additional, Saei, Ayoub, additional, Zambon, Maria, additional, Linley, Ezra, additional, Tonge, Simon, additional, Adaji, Enemona, additional, Adebiyi, Omoyeni, additional, Andrews, Nick, additional, Conneely, Joanna, additional, Conneely, Paul, additional, Dunne, Angela, additional, Dyer, Simone, additional, Emmett, Hannah, additional, Hettiarachchi, Nipunadi, additional, Kapirial, Nishanthan, additional, Khawam, Jameel, additional, Monk, Edward, additional, Russell, Sophie, additional, Taylor-Kerr, Andrew, additional, Timeyin, Jean, additional, D'Arcangelo, Silvia, additional, Rowe, Cathy, additional, Semper, Amanda, additional, Gallagher, Eileen, additional, Kyffin, Robert, additional, Cromey, Lisa, additional, Areghan, Desmond, additional, Bishop, Jennifer, additional, Dembinsky, Melanie, additional, Dobbie, Laura, additional, Evans, Josie, additional, Goldberg, David, additional, Haahr, Lynne, additional, Jorgenson, Annelysse, additional, Matuluko, Ayodeji, additional, Naismith, Laura, additional, Nuryunarsih, Desy, additional, Olaoye, Alexander, additional, Plank, Caitlin, additional, Price, Lesley, additional, Sergenson, Nicole, additional, Stewart, Sally, additional, Telfer, Andrew, additional, Weir, Jennifer, additional, De Lacy, Ellen, additional, Ellis, Yvette, additional, Froude, Susannah, additional, Stevens, Guy, additional, Tyson, Linda, additional, Dunachie, Susanna, additional, Klenerman, Paul, additional, Duncan, Chris, additional, Payne, Rebecca, additional, Turtle, Lance, additional, Richter, Alex, additional, De Silva, Thushan, additional, Barnes, Eleanor, additional, Wootton, Daniel, additional, Galgut, Oliver, additional, Heeney, Jonathan, additional, Baxendale, Helen, additional, Castillo-Olivares, Javier, additional, Beale, Rupert, additional, Carr, Edward, additional, Barclay, Wendy, additional, Moshe, Maya, additional, Palmarini, Massimo, additional, Willett, Brian, additional, Baillie, John Kenneth, additional, Evans, Jennie, additional, and Aquino, Erika, additional

Published
2024
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8. Peripheral Neuropathy in Virologically Suppressed People Living with HIV: Evidence from the PIVOT Trial

Author

Schuldt, Anna L., primary, Bern, Henry, additional, Hart, Melanie, additional, Gompels, Mark, additional, Winston, Alan, additional, Clarke, Amanda, additional, Chen, Fabian, additional, Stöhr, Wolfgang, additional, Heslegrave, Amanda, additional, Paton, Nicholas I., additional, Petzold, Axel, additional, and Arenas-Pinto, Alejandro, additional

Published
2023
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9. How surgical Trainee Research Collaboratives achieve success: a mixed methods study to develop trainee engagement strategies

Author

Clement, Clare, primary, Coulman, Karen, additional, Heywood, Nick, additional, Pinkney, Tom, additional, Blazeby, Jane, additional, Blencowe, Natalie S, additional, Cook, Jonathan Alistair, additional, Bulbulia, Richard, additional, Arenas-Pinto, Alejandro, additional, Snowdon, Claire, additional, Hilton, Zoe, additional, Magill, Laura, additional, MacLennan, Graeme, additional, Glasbey, James, additional, Nepogodiev, Dmitri, additional, Hardy, Victoria, additional, and Lane, J Athene, additional

Published
2023
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12. Hepatic steatosis in people older and younger than fifty who are living with HIV and HIV‐negative controls: A cross‐sectional study nested within the POPPY cohort.

Author

Arenas‐Pinto, Alejandro, Bakewell, Nicholas, Milinkovic, Ana, Williams, Ian, Vera, Jaime, Post, Frank A., Anderson, Jane, Beynon, Michelle, O'Brien, Alastair, Doyle, Nicki, Gilson, Richard, Pett, Sarah L., Winston, Alan, and Sabin, Caroline A.

Subjects
*HIV-positive persons, *KRUSKAL-Wallis Test, *ULTRASONIC imaging, *CONFIDENCE intervals, *FATTY liver, *CROSS-sectional method, *FISHER exact test, *RISK assessment, *COMPARATIVE studies, *WAIST-hip ratio, *RESEARCH funding, *CHI-squared test, *DESCRIPTIVE statistics, *LOGISTIC regression analysis, *ODDS ratio, *DISEASE risk factors, *ADULTS, *MIDDLE age
Abstract

Background: Hepatic steatosis is a major cause of chronic liver disease associated with several negative health outcomes. We compared the prevalence of and factors associated with steatosis in people living with and without HIV. Methods: Older (>50 years) and younger (<50 years) people with HIV and older HIV‐negative controls (>50 years) underwent liver transient elastography examination with controlled attenuation parameter (steatosis ≥238 dB/m, moderate/severe steatosis ≥280 dB/m, liver fibrosis ≥7.1 kPa). We compared groups using logistic regression/Chi‐squared/Fisher's exact/Kruskal–Wallis tests. Results: In total, 317 participants (109 older people with HIV; 101 younger people with HIV; 107 HIV‐negative controls) were predominantly white (86%) and male (76%), and 21% were living with obesity (body mass index ≥30 kg/m2). Most (97%) people with HIV had undetectable HIV RNA. The prevalence of fibrosis was 8.4%, 3.0%, and 6.5% in the three groups, respectively (p = 0.26). Fibrosis was predominately (>65%) mild. The prevalence of steatosis was the same in older people with HIV (66.4%) and controls (66.4%) but lower in younger people with HIV (37.4%; p < 0.001). After adjustment, younger people with HIV were less likely to have steatosis (odds ratio [OR] 0.26; 95% confidence interval [CI] 0.14–0.52) than controls, but male sex (OR 2.45; 95% CI 1.20–4.50) and high waist‐to‐hip ratio (OR 3.04; 95% CI 1.74–5.33) were associated with an increased odds of steatosis. We found no association between steatosis and HIV‐related variables. Conclusions: The prevalence of hepatic steatosis and fibrosis was similar between older participants regardless of HIV status. Age, sex, and abdominal obesity, but not HIV‐related variables, were associated with steatosis. Interventions for controlling obesity should be integrated into routine HIV care. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Peripheral Neuropathy in Virologically Suppressed People Living with HIV: Evidence from the PIVOT Trial.

Author

Schuldt, Anna L., Bern, Henry, Hart, Melanie, Gompels, Mark, Winston, Alan, Clarke, Amanda, Chen, Fabian, Stöhr, Wolfgang, Heslegrave, Amanda, Paton, Nicholas I., Petzold, Axel, and Arenas-Pinto, Alejandro

Subjects
PERIPHERAL neuropathy, HIV-positive persons, CD4 lymphocyte count, HIV infections, BLOOD sugar
Abstract

The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20–63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20–1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12–3.16), height (aOR 1.19, 95% CI of 1.05–1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00–1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Brown, Samuel M, primary, Barkauskas, Christina E, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Phillips, Andrew N, additional, Leither, Lindsay, additional, Peltan, Ithan D, additional, Lanspa, Michael, additional, Gilstrap, Daniel L, additional, Mourad, Ahmad, additional, Lane, Kathleen, additional, Beitler, Jeremy R, additional, Serra, Alexis L, additional, Garcia, Ivan, additional, Almasri, Eyad, additional, Fayed, Mohamed, additional, Hubel, Kinsley, additional, Harris, Estelle S, additional, Middleton, Elizabeth A, additional, Barrios, Macy A G, additional, Mathews, Kusum S, additional, Goel, Neha N, additional, Acquah, Samuel, additional, Mosier, Jarrod, additional, Hypes, Cameron, additional, Salvagio Campbell, Elizabeth, additional, Khan, Akram, additional, Hough, Catherine L, additional, Wilson, Jennifer G, additional, Levitt, Joseph E, additional, Duggal, Abhijit, additional, Dugar, Siddharth, additional, Goodwin, Andrew J, additional, Terry, Charles, additional, Chen, Peter, additional, Torbati, Sam, additional, Iyer, Nithya, additional, Sandkovsky, Uriel S, additional, Johnson, Nicholas J, additional, Robinson, Bryce R H, additional, Matthay, Michael A, additional, Aggarwal, Neil R, additional, Douglas, Ivor S, additional, Casey, Jonathan D, additional, Hache-Marliere, Manuel, additional, Georges Youssef, J, additional, Nkemdirim, William, additional, Leshnower, Brad, additional, Awan, Omar, additional, Pannu, Sonal, additional, O'Mahony, Darragh Shane, additional, Manian, Prasad, additional, Awori Hayanga, J W, additional, Wortmann, Glenn W, additional, Tomazini, Bruno M, additional, Miller, Robert F, additional, Jensen, Jens-Ulrik, additional, Murray, Daniel D, additional, Bickell, Nina A, additional, Zatakia, Jigna, additional, Burris, Sarah, additional, Higgs, Elizabeth S, additional, Natarajan, Ven, additional, Dewar, Robin L, additional, Schechner, Adam, additional, Kang, Nayon, additional, Arenas-Pinto, Alejandro, additional, Hudson, Fleur, additional, Ginde, Adit A, additional, Self, Wesley H, additional, Rogers, Angela J, additional, Oldmixon, Cathryn F, additional, Morin, Haley, additional, Sanchez, Adriana, additional, Weintrob, Amy C, additional, Cavalcanti, Alexandre Biasi, additional, Davis-Karim, Anne, additional, Engen, Nicole, additional, Denning, Eileen, additional, Taylor Thompson, B, additional, Gelijns, Annetine C, additional, Kan, Virginia, additional, Davey, Victoria J, additional, Lundgren, Jens D, additional, Babiker, Abdel G, additional, Neaton, James D, additional, Lane, H Clifford, additional, Tierney, John, additional, Vogel, Susan E., additional, McNay, Laura A., additional, Cahill, Kelly, additional, Crew, Page, additional, Sardana, Ratna, additional, Segal Raim, Sharo, additional, Shaw-Saliba, Katy, additional, Atri, Negin, additional, Miller, Mark, additional, Vallee, David, additional, Chung, Lucy, additional, Delph, Yvette, additional, Adam, Stacey J., additional, Read, Sarah, additional, Draghia-Akli, Ruxandra, additional, Harrigan, Rachel, additional, Carlsen, Amy, additional, Carter, Anita, additional, DuChene, Alain, additional, Eckroth, Kate, additional, Frase, Alex, additional, Harrison, Merrie, additional, Meger, Sue, additional, Quan, Kien, additional, Quan, Siu Fun, additional, Reilly, Cavan, additional, Thompson, Greg, additional, Walski, Jamie, additional, Moskowitz, Alan J., additional, Bagiella, Emilia, additional, Moquete, Ellen, additional, O'Sullivan, Karen, additional, Marks, Mary E., additional, Accardi, Evan, additional, Kinzel, Emily, additional, Bedoya, Gabriela, additional, Gupta, Lopa, additional, Overbey, Jessica R., additional, Padillia, Maria L., additional, Santos, Milerva, additional, Gillinov, Marc A., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Fenton, Kathleen, additional, Smith, Peter K., additional, Vekstein, Andrew M., additional, Ko, Emily R., additional, Al-Hegelan, Mashael S., additional, McGowan, Lauren M., additional, Motta, Mary, additional, Howell, Shauna, additional, Bent, Francine, additional, Kalager, Rachel, additional, Chan, Emmanuel, additional, Aloor, Heather L., additional, Griffin, S. Michelle, additional, Covington, Anna, additional, McLendon-Arvik, Beth, additional, Bussadori, Barbara, additional, Miller-Bell, Mary, additional, Sampey, Cathy, additional, Gaver, Vincent, additional, Hollister, Beth A., additional, Giangiacomo, Dana M., additional, Pauley, Alena, additional, Patel, Aashay, additional, Classon, Chris, additional, Frazier, Madison, additional, Osborne, Robyn, additional, Conlon, Debbi H., additional, Joshi, Marybeth, additional, Gottlieb, Robert L., additional, Mack, Michael, additional, Berhe, Mezgebe, additional, Haley, Clinton, additional, Dishner, Emma, additional, Bettacchi, Christopher, additional, Golden, Kevin, additional, Duhaime, Erin, additional, Ryan, Madison, additional, Tallmadge, Catherine, additional, Estrada, Lorie, additional, Jones, Felecia, additional, Villa, Samantha, additional, Wang, Samantha, additional, Robert, Raven, additional, Coleman, Tanquinisha, additional, Clariday, Laura, additional, Baker, Rebecca, additional, Hurutado-Rodriguez, Mariana, additional, Iram, Nazia, additional, Fresnedo, Michelle, additional, Davis, Allyson, additional, Leonard, Kiara, additional, Ramierez, Noelia, additional, Thammavong, Jon, additional, Duque, Krizia, additional, Turner, Emma, additional, Fisher, Tammy, additional, Robinson, Dianna, additional, Ransom, Desirae, additional, Maldonado, Nicholas, additional, Lusk, Erica, additional, Killian, Aaron, additional, Palacios, Adriana, additional, Solis, Edilia, additional, Jerrow, Janet, additional, Watts, Matthew, additional, Whitacre, Heather, additional, Cothran, Elizabeth, additional, Bender, William, additional, Miller, Jeffrey, additional, Nugent, Katherine, additional, Farrington, Woodrow, additional, Baio, Kim T., additional, McBride, Mary K., additional, Fielding, Michele, additional, Mathewson, Sonya, additional, Porte, Kristina, additional, Haley, Elizabeth, additional, Rogers, Susan, additional, Tyler, Derrick, additional, Perin, Emerson, additional, Costello, Briana, additional, Postalian, Alexander, additional, Sohail, Rizwan, additional, Hinsu, Punit, additional, Watson, Carolyn, additional, Kappenman, Casey, additional, Chen, James, additional, Walker, Kim, additional, Fink, Melyssa, additional, Phillip, Gabrielle, additional, Mahon, Kim, additional, Sturgis, Lydia, additional, Maher, Patrick, additional, Rogers, Linda, additional, Ng, Nicole, additional, Marshall, Jason, additional, Bassily-Marcus, Adel, additional, Cohen, Ivy, additional, Ramoo, Shamini, additional, Malhotra, Aryan, additional, Kessler, Jonathan, additional, Goetz, Rebekah, additional, Badhwar, Vinay, additional, Hayanga, Jeremiah, additional, Giblin Sutton, Lisa, additional, Williams, Roger, additional, Berry Bartolo, Elizabeth, additional, Walker, Dmitry, additional, Bunner, Robin, additional, Glaze, Chad, additional, Aucremanne, Tanja, additional, Bishop, James, additional, Kelley, Macey, additional, Peterson, Autumn, additional, Sauerborn, Erica, additional, Reckart, Robin, additional, Miller, Brittany, additional, Mittel, Aaron, additional, Darmanian, Anita, additional, Rosen, Amanda, additional, Madahar, Purnema, additional, Schicchi, John, additional, Gosek, Katarzyna, additional, Dzierba, Amy, additional, Wahab, Romina, additional, Eng, Connie, additional, Al-Saadi, Mukhtar, additional, Zahiruddin, Faisal, additional, Syed, Mohi, additional, George, Michael, additional, Patel, Varsha, additional, Onwunyi, Chisom, additional, Barroso da Costa, Rosa, additional, North, Crystal, additional, Ringwood, Nancy, additional, Fitzgerald, Laura, additional, Muzikansky, Ariela, additional, Morse, Richard, additional, Brower, Roy G., additional, Reineck, Lora A., additional, Bienstock, Karen, additional, Hou, Peter, additional, Steingrub, Jay S., additional, Tidswell, Mark A., additional, Kozikowski, Lori-Ann, additional, Kardos, Cynthia, additional, De Souza, Leslie, additional, Talmor, Daniel, additional, Shapiro, Nathan, additional, Hibbert, Kathryn, additional, Brait, Kelsey, additional, Kone, Mamary, additional, Hendey, Gregory, additional, Kangelaris, Kirsten N., additional, Ashktorab, Kimia, additional, Gropper, Rachel, additional, Agrawal, Anika, additional, Timothy, Kelly, additional, Zhou, Hanjing, additional, Hughes, Alyssa, additional, Garcia, Rebekah, additional, Torres, Adrian, additional, Hernandez-Almaraz, Maria Elena, additional, Vojnik, Rosemary, additional, Perez, Cynthia, additional, McDowell, Jordan, additional, Chang, Steven Y., additional, Vargas, Julia, additional, Moss, Marc, additional, McKeehan, Jeffrey, additional, Higgins, Carrie, additional, Johnson, Emily, additional, Slaughter, Suzanne, additional, Wyles, David, additional, Hiller, Terra, additional, Oakes, Judy, additional, Garcia, Ana, additional, Gravitz, Stephanie, additional, Lyle, Carolynn, additional, Swanson, Diandra, additional, Gong, Michelle Ng., additional, Richardson, Lynnne D., additional, Chen, Jen-Ting, additional, Moskowitz, Ari, additional, Mohamed, Amira, additional, Lopez, Brenda, additional, Amosu, Omowunmi, additional, Tzehaie, Hiwet, additional, Boujid, Sabah, additional, Bixby, Billie, additional, Lopez, Anitza A., additional, Durley, JaVon, additional, Gilson, Boris, additional, Hite, R. Duncan, additional, Wang, Henry, additional, Wiedemann, Hebert P., additional, Mehkri, Omar, additional, Ashok, Kiran, additional, King, Alexander, additional, Brennan, Connery, additional, Exline, Matthew C., additional, Englert, Joshua A., additional, Karow, Sarah, additional, Schwartz, Elizabeth, additional, So, Preston, additional, So, Madison, additional, Krol, Olivia F., additional, Briceno Parra, Genesis I., additional, Mills, Emmanuel Nii Lantei, additional, Oh, Minn, additional, Pena, Jose, additional, Martínez, Jesús Alejandro, additional, Jackman, Susan E., additional, Bayoumi, Emad, additional, Pascual, Ethan, additional, Caudill, Antonina, additional, Chen, Po-En, additional, Richardson, Tabia, additional, Clapham, Gregg J., additional, Herrera, Lisa, additional, Ojukwu, Cristabelle, additional, Fine, Devin, additional, Gomez, Millie J., additional, Choi-Kuaea, Yunhee, additional, Weissberg, Gwendolyn, additional, Isip, Katherine, additional, Mattison, Brittany, additional, Tran, Dana, additional, Emilov Dukov, Jennifer, additional, Chung, Paul, additional, Kang, Bo Ran, additional, Escobar, Lauren, additional, Tran, Trung, additional, Baig, Saba, additional, Wallick, Julie A., additional, Duven, Alexandria M., additional, Fletcher, Dakota D., additional, Gundel, Stephanie, additional, Fuentes, Megan, additional, Newton, Maranda, additional, Peterson, Emily, additional, Jiang, Kelsey, additional, Files, D. Clark, additional, Miller, Chadwick, additional, Lematty, Caitlin, additional, Rasberry, April, additional, Warden, Ashley, additional, Bledsoe, Joseph, additional, Knowlton, Kirk, additional, Knox, Daniel B., additional, Klippel, Carolyn, additional, Armbruster, Brent P., additional, Applegate, Darrin, additional, Imel, Karah, additional, Fergus, Melissa, additional, Rahmati, Kasra, additional, Jensen, Hannah, additional, Aston, Valerie T., additional, Jeppson, Joshua, additional, Marshall, J. Hunter, additional, Lumpkin, Jenna, additional, Smith, Cassie, additional, Burke, Tyler, additional, Gray, Andrew, additional, Paine, Robert, additional, Callahan, Sean, additional, Yamane, Misty, additional, Waddoups, Lindsey, additional, Rice, Todd W., additional, Johnson, Jakea, additional, Gray, Christopher, additional, Hays, Margaret, additional, Roth, Megan, additional, Musick, Sarah, additional, Miller, Karen, additional, Semler, Matthew W., additional, Popielski, Laura, additional, Kambo, Amy, additional, Viens, Kimberly, additional, Turner, Melissa, additional, Vjecha, Michael J., additional, Denyer, Rachel, additional, Khosla, Rahul, additional, Rajendran, Bindu, additional, Gonzales, Melissa, additional, Moriarty, Theresa, additional, Biswas, Kousick, additional, Harrington, Cristin, additional, Garcia, Amanda, additional, Bremer, Tammy, additional, Burke, Tara, additional, Koker, Brittany, additional, Pittman, David, additional, Vasudeva, Shikha S., additional, Anholm, James D., additional, Specht, Lennard, additional, Rodriguez, Aimee, additional, Ngo, Han, additional, Duong, Lien, additional, Previte, Matthew, additional, Raben, Dorthe, additional, Nielsen, Charlotte B., additional, Friis Larsen, Jakob, additional, Peters, Lars, additional, Matthews, Gail, additional, Kelleher, Anthony, additional, Polizzotto, Mark, additional, Carey, Catherine, additional, Chang, Christina, additional, Dharan, Nila, additional, Hough, Sally, additional, Virachit, Sophie, additional, Davidson, Sarah, additional, Bice, Daniel J., additional, Ognenovska, Katherine, additional, Cabrera, Gesalit, additional, Flynn, Ruth, additional, Abdelghany, Mazin, additional, Baseler, Beth, additional, Teitelbaum, Marc, additional, Holley, H. Preston, additional, Jankelevich, Shirley, additional, Adams, Amy, additional, Becker, Nancy, additional, Doleny, Suzanne, additional, Hissey, Debbie, additional, Simpson, Shelly, additional, Kim, Mi Ha, additional, Beeler, Joy, additional, Harmon, Liam, additional, Vanderpuye, Sharon, additional, Yeon, Lindsey, additional, Frye, Leanna, additional, Rudzinski, Erin, additional, Buehn, Molly, additional, Eccard-Koons, Vanessa, additional, Frary, Sadie, additional, MacDonalad, Leah, additional, Cash, Jennifer, additional, Hoopengardner, Lisa, additional, Linton, Jessica, additional, Nelson, Michaela, additional, Spinelli-Nadzam, Mary, additional, Proffitt, Calvin, additional, Lee, Christopher, additional, Engel, Theresa, additional, Fontaine, Laura, additional, Osborne, CK, additional, Hohn, Matt, additional, Galcik, Michael, additional, Thompson, DeeDee, additional, Sandrus, Jen, additional, Manchard, Jon, additional, Giri, Jiwan, additional, Kopka, Stacy, additional, Chang, Weizhong, additional, Sherman, Brad T., additional, Rupert, Adam W., additional, Highbarger, Helene, additional, Baseler, Michael, additional, Lallemand, Perrine, additional, Rehman, Tauseef, additional, Imamichi, Tom, additional, Laverdure, Sylvain, additional, Paudel, Sharada, additional, Cook, Kyndal, additional, Haupt, Kendra, additional, Hazen, Allison, additional, Badralmaa, Yunden, additional, Highbarger, Jeroen, additional, McCormack, Ashley, additional, Gerry, Norman P., additional, Smith, Kenneth, additional, Patel, Bhakti, additional, Domeraski, Nadia, additional, Hoover, Marie L., additional, DuChateau, Nadine, additional, Flosi, Adam, additional, Nelson, Rich, additional, Stojanovic, Jelena, additional, and Wenner, Christine, additional

Published
2023
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17. A descriptive analysis of transient elastography results and metabolic co-morbidities in people living with HIV mono-infection in an urban clinic in the UK

Author

Mullender, Claire, primary, Owen, Rhiannon, additional, Kohli, Manik, additional, Maan, Irfaan, additional, Waters, Laura Jane, additional, Pett, Sarah, additional, Arenas-Pinto, Alejandro, additional, Ghosh, Indrajit, additional, Flanagan, Stuart, additional, and Gilson, Richard, additional

Published
2023
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18. High prevalence of hepatic steatosis in adults living with hepatitis B, with and without HIV co-infection, in London, UK

Author

Mullender, Claire, primary, Kemper, Angieszka, additional, Ogunnaike, Stephen, additional, Pett, Sarah, additional, Maan, Irfaan, additional, Kohli, Manik, additional, Peppa, Dimitra, additional, Arenas-Pinto, Alejandro, additional, Flanagan, Stuart, additional, Ghosh, Indrajit, additional, Gilson, Richard, additional, and Matthews, Philippa, additional

Published
2023
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23. Neurocognitive Function and Neuroimaging Markers in Virologically Suppressed HIV-positive Patients Randomized to Ritonavir-boosted Protease Inhibitor Monotherapy or Standard Combination ART: A Cross-sectional Substudy From the PIVOT Trial

Author

PIVOT Neurocognitive sub-study Team, Arenas-Pinto, Alejandro, Stöhr, Wolfgang, Jäger, Hans Rolf, Haddow, Lewis, Clarke, Amanda, Johnson, Margaret, Chen, Fabian, Winston, Alan, Godi, Claudia, Thust, Steffi, Trombin, Rita, Cairns, Janet, Solanky, Bhavana S., Golay, Xavier, and Paton, Nicholas I.

Published
2016

27. Trypanosoma cruziscreening in people living with HIV in the UK

Author

Ahmed, Nadia, Herbert, Sophie, Arenas-Pinto, Alejandro, Rickman, Hannah, Benn, Paul, Edwards, Simon G, Chiodini, Peter L, and Grant, Alison D

Abstract

People living with HIV (PLWH) are at higher risk of reactivation of Chagas disease, a neglected tropical disease, caused by Trypanosoma cruzi. There are no data from UK HIV clinics on the prevalence of T. cruzi. We implemented T. cruziscreening at our clinic as part of routine care for PLWH with epidemiological risk factors. Among 86 patients screened, none had positive serology: one seropositive patient was identified due to increased clinician awareness. Implementing T. cruziscreening as part of routine clinical care was feasible, though labour intensive and identified at-risk individuals.

Published
2024
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30. Using trained dogs and organic semi-conducting sensors to identify asymptomatic and mild SARS-CoV-2 infections: an observational study

Author

Guest, Claire, Dewhirst, Sarah Y, Lindsay, Steve W, Allen, David J, Aziz, Sophie, Baerenbold, Oliver, Bradley, John, Chabildas, Unnati, Chen-Hussey, Vanessa, Clifford, Samuel, Cottis, Luke, Dennehy, Jessica, Foley, Erin, Gezan, Salvador A, Gibson, Tim, Greaves, Courtenay K, Kleinschmidt, Immo, Lambert, Sébastien, Last, Anna, Morant, Steve, Parker, Josephine E A, Pickett, John, Quilty, Billy J, Rooney, Ann, Shah, Manil, Somerville, Mark, Squires, Chelci, Walker, Martin, Logan, James G, Jones, Robert, Assis, Ana, Borthwick, Ewan, Caton, Laura, Edwards, Rachel, Heal, Janette, Hill, David, Jahan, Nazifa, Johnson, Cecelia, Kaye, Angela, Kirkpatrick, Emily, Kisha, Sarah, Ledeatte Williams, Zaena, Moar, Robert, Owonibi, Tolulope, Purcell, Benjamin, Rixson, Christopher, Spencer, Freya, Stefanidis, Anastasios, Stewart, Sophie, Tytheridge, Scott, Wakley, Sian, Wildman, Shanice, Aziz, Catherine, Care, Helen, Curtis, Emily, Dowse, Claire, Makepeace, Alan, Oultram, Sally-Anne, Smith, Jayde, Shenton, Fiona, Hutchins, Harry, Mart, Robert, Cartwright, Jo-anne, Forsey, Miranda, Goodsell, Kerry, Kittridge, Lauren, Nicholson, Anne, Ramos, Angelo, Ritches, Joanne, Setty, Niranjan, Vertue, Mark, Bergstrom, Malin, Chaudhary, Zain, De Wilton, Angus, Gaskell, Kate, Houlihan, Catherine, Jones, Imogen, Margaritis, Marios, Miralhes, Patricia, Owens, Leah, Rampling, Tommy, Rickman, Hannah, Boffito, Marta, Fernandez, Candida, Cotterell, Bryony, Guerdette, Anne-Marie, Tsaknis, George, Turns, Margaret, Walsh, Joanne, Frankland, Lisa, West, Raha, Holland, Maureen, Keenan, Natalie, Wassall, Helen, Young, Megan, Rangeley, Jade, Saalmink, Gwendolyn, Adlakha, Sanjay, Buckley, Philip, Allsop, Lynne, Smith, Susan, Sowter, Donna, Campbell, Alison, Jones, Julie, Laird, Steve, O’Toole, Sarah, Ryan, Courteney, Evans, Jessica, Rand, James, Schumacher, Natasha, Hazelton, Tracey, Dodgson, Andrew, Glasgow, Susannah, Kadiu, Denise, Lopuszansky, Orianne, Oommen, Anu, Prabhu, Joshi, Pursell, Molly, Turner, Jane, Walton, Hollie, Andrews, Robert, Cruickshank, Irena, Thompson, Catherine, Wainwright, Tania, Roebuck, Alun, Lawrence, Tara, Netherton, Kimberley, Hewitt, Claire, Shephardson, Sarah, Crasto, Winston Andrew, Lake, Judith, Musanhu, Rosemary, Walker, Rebecca, Burns, Karen, Higham, Andrew, Le Bas, Julie, Mackenzie, Nicola, Thatcher, Hilary, Beadle, Shannen, Buckley, Sarah, Castle, Gail, Fletcher, Aimee, Holbrook, Sara, Kane, Patricia, Lindley, Kate, Lowry, Tracey, Lupton, Stephanie, Oddy, Sharon, Slater, Lynda, Sylvester, Martin, Agwuh, Kenneth, Maxwell, Veronica, Ryder, Stephen, Topham, Kirsty, Egbuniwe, Obi, Matthews, Rebecca, Arenas-Pinto, Alejandro, Prymas, Paulina, Severn, Abigail, Shaw, Amber, Begum, Safia, Lenton, Daniel, Scriven, James, Leeman, Lucy, Rudge, Karen, Storr, Emma, Alvarez, Ana, Forster, Kate, Hind, Daniel, Cook, Natalie, Peeling, Rosanna, Carey, Peter, Wilson, Anne, and Davis, Jane

Subjects
Volatile Organic Compounds, Dogs, SARS-CoV-2, fungi, Animals, COVID-19, Humans, Mass Screening, General Medicine, Asymptomatic Infections, Sensitivity and Specificity
Abstract

Background A rapid, accurate, non-invasive diagnostic screen is needed to identify people with SARS-CoV-2 infection. We investigated whether organic semi-conducting (OSC) sensors and trained dogs could distinguish between people infected with asymptomatic or mild symptoms, and uninfected individuals, and the impact of screening at ports-of-entry. Methods Odour samples were collected from adults, and SARS-CoV-2 infection status confirmed using RT-PCR. OSC sensors captured the volatile organic compound (VOC) profile of odour samples. Trained dogs were tested in a double-blind trial to determine their ability to detect differences in VOCs between infected and uninfected individuals, with sensitivity and specificity as the primary outcome. Mathematical modelling was used to investigate the impact of bio-detection dogs for screening. Results About, 3921 adults were enrolled in the study and odour samples collected from 1097 SARS-CoV-2 infected and 2031 uninfected individuals. OSC sensors were able to distinguish between SARS-CoV-2 infected individuals and uninfected, with sensitivity from 98% (95% CI 95–100) to 100% and specificity from 99% (95% CI 97–100) to 100%. Six dogs were able to distinguish between samples with sensitivity ranging from 82% (95% CI 76–87) to 94% (95% CI 89–98) and specificity ranging from 76% (95% CI 70–82) to 92% (95% CI 88–96). Mathematical modelling suggests that dog screening plus a confirmatory PCR test could detect up to 89% of SARS-CoV-2 infections, averting up to 2.2 times as much transmission compared to isolation of symptomatic individuals only. Conclusions People infected with SARS-CoV-2, with asymptomatic or mild symptoms, have a distinct odour that can be identified by sensors and trained dogs with a high degree of accuracy. Odour-based diagnostics using sensors and/or dogs may prove a rapid and effective tool for screening large numbers of people. Trial Registration NCT04509713 (clinicaltrials.gov).

Published
2022

32. Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.

Author

Lundgren, Jens D., Babiker, Abdel G., Sharma, Shweta, Grund, Birgit, Phillips, Andrew N., Matthews, Gail, Kan, Virginia L., Aagaard, Bitten, Abo, Inka, Alston, Beverly, Arenas-Pinto, Alejandro, Avihingsanon, Anchalee, Badal-Faesen, Sharlaa, Brites, Carlos, Carey, Cate, Casseb, Jorge, Clarke, Amanda, Collins, Simon, Corbelli, Giulio Maria, and Dao, Sounkalo

Subjects
HIV prevention, HIV infections, HIV-positive persons, CONFIDENCE intervals, VIRAL load, ANTIRETROVIRAL agents, HIGHLY active antiretroviral therapy, CD4 lymphocyte count, STATISTICAL sampling, EARLY medical intervention, PROPORTIONAL hazards models, LONGITUDINAL method
Abstract

Background: For people with HIV and CD4+ counts >500 cells/mm³, early initiation of antiretroviral therapy (ART) reduces serious AIDS and serious non-AIDS (SNA) risk compared with deferral of treatment until CD4+counts are <350 cells/mm³. Whether excess risk of AIDS and SNA persists once ART is initiated for those who defer treatment is uncertain. Methods: The Strategic Timing of AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults with CD4+counts >500 cells/mm³ to immediate treatment initiation after random assignment (n=2325) or deferred treatment (n= 2359). In 2015, a 57% lower risk of the primary end point (AIDS, SNA, or death) for the immediate group was reported, and the deferred group was offered ART. This article reports the follow-up that continued to December 31, 2021. Cox proportional-hazards models were used to compare hazard ratios for the primary end point from randomization through December 31, 2015, versus January 1, 2016, through December 31, 2021. Results: Through December 31, 2015, approximately 7 months after the cutoff date from the previous report, the median CD4+ count was 648 and 460 cells/mm³ in the immediate and deferred groups, respectively, at treatment initiation. The percentage of follow-up time spent taking ART was 95% and 36% for the immediate and deferred groups, respectively, and the time-averaged CD4+ difference was 199 cells/mm³. After January 1, 2016, the percentage of follow-up time on treatment was 97.2% and 94.1% for the immediate and deferred groups, respectively, and the CD4+ count difference was 155 cells/mm³. After January 1, 2016, a total of 89 immediate and 113 deferred group participants experienced a primary end point (hazard ratio of 0.79 [95% confidence interval, 0.60 to 1.04] versus hazard ratio of 0.47 [95% confidence interval, 0.34 to 0.65; P<0.001]) before 2016 (P=0.02 for hazard ratio difference). Conclusions: Among adults with CD4+ counts >500 cells/mm³, excess risk of AIDS and SNA associated with delaying treatment initiation was diminished after ART initiation, but persistent excess risk remained. (Funded by the National Institute of Allergy and Infectious Diseases and others.) In people with HIV and CD4+ counts >500 cells/mm³, immediate initiation of ART reduced serious AIDS and SNA risk, the primary end point, compared with deferring ART until CD4+counts were <350 cells/mm³. Beginning in 2016 after the deferred group was advised to initiate ART, 89 immediate and 113 deferred group participants experienced a primary end point. Persistent excess risk of the primary end point remained in the deferred compared to the immediate ART group. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Human Immunotypes Impose Selection on Viral Genotypes Through Viral Epitope Specificity

Author

Gabrielaite, Migle, Bennedbæk, Marc, Zucco, Adrian G., Ekenberg, Christina, Murray, Daniel D., Kan, Virginia L., Touloumi, Giota, Vandekerckhove, Linos, Turner, Dan, Neaton, James, Clifford Lane, H., Safo, Sandra, Arenas-Pinto, Alejandro, Polizzotto, Mark N., Günthard, Huldrych F., Lundgren, Jens D., Marvig, Rasmus L., Gabrielaite, Migle, Bennedbæk, Marc, Zucco, Adrian G., Ekenberg, Christina, Murray, Daniel D., Kan, Virginia L., Touloumi, Giota, Vandekerckhove, Linos, Turner, Dan, Neaton, James, Clifford Lane, H., Safo, Sandra, Arenas-Pinto, Alejandro, Polizzotto, Mark N., Günthard, Huldrych F., Lundgren, Jens D., and Marvig, Rasmus L.

Abstract

Background: Understanding the genetic interplay between human hosts and infectious pathogens is crucial for how we interpret virulence factors. Here, we tested for associations between HIV and host genetics, and interactive genetic effects on viral load (VL) in HIV-positive antiretroviral treatment-naive clinical trial participants. Methods: HIV genomes were sequenced and the encoded amino acid (AA) variants were associated with VL, human single nucleotide polymorphisms (SNPs), and imputed HLA alleles using generalized linear models with Bonferroni correction. Results: Human (388 501 SNPs) and HIV (3010 variants) genetic data were available for 2122 persons. Four HIV variants were associated with VL (P < 1.66 × 10-5). Twelve HIV variants were associated with a range of 1-512 human SNPs (P < 4.28 × 10-11). We found 46 associations between HLA alleles and HIV variants (P < 1.29 × 10-7). HIV variants and immunotypes when analyzed separately were associated with lower VL, whereas the opposite was true when analyzed in concert. Epitope binding predictions supported our observations. Conclusions: Our results show the importance of immunotype specificity on viral antigenic determinants, and the identified genetic interplay emphasizes that viral and human genetics should be studied in the context of each other. Clinical Trials Registration: NCT00867048.

Published
2021

35. Learning and memory function in young people with and without perinatal HIV in England.

Author

Arenas-Pinto, Alejandro, Judd, Ali, Melvin, Diane, Le Prevost, Marthe, Foster, Caroline, Sturgeon, Kate, Winston, Alan, Thompson, Lindsay C., Gibb, Diana M., and Castro, Hannah

Subjects
*YOUNG adults, *VERBAL learning, *COGNITIVE ability, *EXECUTIVE function, *COGNITIVE development, *ORPHANS, *ETHNICITY
Abstract

Learning and memory are important for successful education and career progression. We assess these functions in young people (YP) with perinatal HIV (PHIV) (with or without a previous AIDS-defining illness) and a comparable group of HIV-negative YP. 234 PHIV and 68 HIV-negative YP completed 9 tests; 5 National Institutes of Health (NIH) Toolbox tests (2 executive function, 1 speed of information processing, 2 memory); 2 Hopkins Verbal Learning Test Revised (HVLT-R) (learning (L), delayed recall (R)), and 2 verbal application measures. Z-scores for each test were calculated using normative data and averaged by domain where appropriate. The effect of predictors on test scores in the three domains with the lowest z-scores were analysed using linear regression. 139(59%) and 48(71%) PHIV and HIV-negative YP were female, 202(86%) and 52(76%) Black, and median age was 19 [17, 21] and 18 [16, 21] years respectively. 55(24%) PHIV had a previous Center for Disease Control and Prevention (CDC) class C AIDS-defining diagnosis (PHIV/C). For HVLT-R, there was a trend towards PHIV/C YP having the lowest mean z-scores (L -1.5 (95% CI -1.8,-1.2), R -1.7 (-2.0,-1.4)) followed by PHIV without a CDC C diagnosis (L -1.3 (-1.4,-1.1), R -1.4 (-1.5,-1.2)) and then the HIV-negative group (L -1.0 (-1.3,-0.7), R -1.1 (-1.3,-0.8)); all were greater than 1 SD below the reference mean. The same trend was seen for verbal application measures; however, z-scores were within 1 SD below the reference mean. NIH Toolbox tests were similar for all groups. In multivariable analyses PHIV/C and Black ethnicity predicted lower HVLT-R scores. Black ethnicity also predicted lower executive function scores, however each year increase in age predicted higher scores. In conclusion, cognitive performance in verbal learning and recall fell below population normative scores, and was more pronounced in PHIV/C, supporting wider findings that earlier antiretroviral therapy initiation, before the occurrence of AIDS-defining conditions, may protect aspects of cognitive development. [ABSTRACT FROM AUTHOR]

Published
2022
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36. Human Immunotypes Impose Selection on Viral Genotypes Through Viral Epitope Specificity

Author

Gabrielaite, Migle, primary, Bennedbæk, Marc, additional, Zucco, Adrian G, additional, Ekenberg, Christina, additional, Murray, Daniel D, additional, Kan, Virginia L, additional, Touloumi, Giota, additional, Vandekerckhove, Linos, additional, Turner, Dan, additional, Neaton, James, additional, Lane, H Clifford, additional, Safo, Sandra, additional, Arenas-Pinto, Alejandro, additional, Polizzotto, Mark N, additional, Günthard, Huldrych F, additional, Lundgren, Jens D, additional, and Marvig, Rasmus L, additional

Published
2021
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39. Alcohol, smoking, recreational drug use and association with virological outcomes among people living with HIV: cross‐sectional and longitudinal analyses.

Author

Jones, Timothy P. W., Lampe, Fiona C., Arenas‐Pinto, Alejandro, Smith, Colette, McDonnell, Jeff, Haddow, Lewis, Johnson, Margaret, Yousef, Elaney, Lascar, Monica, Maria Geretti, Anna, Sherr, Lorraine, Collins, Simon, Phillips, Andrew N., and Rodger, Alison J.

Subjects
HIV infections, ALCOHOLISM, CONFIDENCE intervals, CROSS-sectional method, VIRAL load, ANTIRETROVIRAL agents, DRUG abuse, REGRESSION analysis, TREATMENT effectiveness, SOCIOECONOMIC factors, SEX distribution, QUESTIONNAIRES, DESCRIPTIVE statistics, SMOKING, PATIENT compliance, MEN who have sex with men, ODDS ratio, PSYCHOLOGY of HIV-positive persons, LONGITUDINAL method, EVALUATION
Abstract

Objectives: There is increasing evidence to suggest that people living with HIV (PLWH) have significant morbidity from alcohol, recreational drug use and cigarette smoking. Our aim was to report associations of these factors with antiretroviral therapy (ART) non‐adherence, viral non‐suppression and subsequent viral rebound in PLWH. Methods: The Antiretroviral Sexual Transmission Risk and Attitudes (ASTRA) study recruited PLWH attending eight outpatient clinics in England between February 2011 and December 2012. Data included self‐reported excessive drinking (estimated consumption of > 20 units of alcohol/week), alcohol dependency (CAGE score ≥ 2 with current alcohol consumption), recreational drug use (including injection drug use in the past 3 months), and smoking status. Among participants established on ART, cross‐sectional associations with ART non‐adherence [missing ≥2 consecutive days of ART on ≥2 occasions in the past three months] and viral‐non suppression [viral load (VL) > 50 copies/mL] were assessed using logistic regression. In participants from one centre, longitudinal associations with subsequent viral rebound (first VL > 200 copies/mL) in those on ART with VL ≤ 50 copies/mL at baseline were assessed using Cox regression during a 7‐year follow‐up. Results: Among 3258 PLWH, 2248 (69.0%) were men who have sex with men, 373 (11.4%) were heterosexual men, and 637 (19.6%) were women. A CAGE score ≥ 2 was found in 568 (17.6%) participants, 325 (10.1%) drank > 20 units/week, 1011 (31.5%) currently smoked, 1242 (38.1%) used recreational drugs and 74 (2.3%) reported injection drug use. In each case, prevalence was much more common among men than among women. Among 2459 people on ART who started at least 6 months previously, a CAGE score ≥ 2, drinking > 20 units per week, current smoking, injection and non‐injection drug use were all associated with ART non‐adherence. After adjusting for demographic and socioeconomic factors, CAGE score ≥ 2 [adjusted odds ratio (aOR) = 1.52, 95% confidence interval (CI): 1.09–2.13], current smoking (aOR = 1.58, 95% CI: 1.10–2.17) and injection drug use (aOR = 2.11, 95% CI: 1.00–4.47) were associated with viral non‐suppression. During follow‐up of a subset of 592 people virally suppressed at recruitment, a CAGE score ≥ 2 [adjusted hazard ratio (aHR) = 1.66, 95% CI: 1.03–2.74], use of 3 or more non‐injection drugs (aHR = 1.82, 95% CI: 1.12–3.57) and injection drug use (aHR = 2.73, 95% CI: 1.08–6.89) were associated with viral rebound. Conclusions: Screening and treatment for alcohol, cigarette and drug use should be integrated into HIV outpatient clinics, while clinicians should be alert to the potential for poorer virological outcomes. [ABSTRACT FROM AUTHOR]

Published
2022
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42. Next generation sequencing of HIV-1 protease in the PIVOT trial of protease inhibitor monotherapy

Author

Dunn, David T., Stöhr, Wolfgang, Arenas-Pinto, Alejandro, Tostevin, Anna, Mbisa, Jean L., and Paton, Nicholas I.

Subjects
Sequence Analysis, RNA, Resistance, HIV, High-Throughput Nucleotide Sequencing, HIV Infections, HIV Protease Inhibitors, Viral Load, Article, Treatment Outcome, Protease inhibitor, England, HIV Protease, NGS, Drug Resistance, Viral, Mutation, HIV-1, Humans, RNA, Viral
Abstract

Highlights • Next generation sequencing (NGS) was performed on patients on PI monotherapy. • It revealed previously unidentified minority variant protease mutations in 3 samples. • These mutations do not predict clinically important phenotypic resistance., Background The PIVOT trial examined whether patients with suppressed viral load on combination antiretroviral therapy could be safely switched long-term to ritonavir-boosted protease inhibitor (PI) monotherapy. The main trial publication reported that only one of 296 patients allocated to PI monotherapy experienced a loss of drug options due to protease mutations (identified by local Sanger sequencing resistance tests) likely selected by study drug. Objectives To assess if we had missed low frequency mutations, using a more sensitive methodology. Study design We performed next generation sequencing (NGS) on all available frozen plasma samples with VL >1000 copies/ml from patients who were randomised to PI monotherapy. Assays were performed at Public Health England laboratories using a previously described method. Median coverage depth was 76,000 and the threshold for detection of minority variants was 2%. Drug susceptibility was predicted using the Stanford HIVdb algorithm. Results 17 of 26 potential samples, all from different patients, were identified and successfully tested. The median viral load was 6780 copies/ml and the median time since randomisation was 43 weeks. NGS revealed previously unidentified minority variant protease mutations (G73D, I54T, L89V) in three samples, at frequencies ranging between 2% and 10%. None of these mutations predicted intermediate or high level resistance, the trial primary outcome. Discussion This report adds to the body of evidence that ritonavir-boosted PI monotherapy, when used as a switch strategy with prompt detection of viral load rebound and early re-introduction of combination therapy, rarely leads to the development of clinically important protease resistance mutations.

Published
2018

43. Low clinical relevance of risky alcohol consumption in a selected group of high adherent HIV‐infected patients attended in the United Kingdom

Author

Baeza, Alicia Gonzalez, Milinkovic, Ana, and Arenas?Pinto, Alejandro

Subjects
Drinking of alcoholic beverages -- Health aspects, Cognition disorders -- Risk factors, HIV infection -- Development and progression -- Care and treatment, Health
Abstract

Introduction: The prevalence of risky alcohol consumption, associated factors and its impact on the brain is not well established in clinically stable HIV patients. Materials and Methods: Within the PIVOT neurocognitive sub‐study, effectively suppressed HIV‐infected adults on either standard cART or ritonavir‐boosted PI monotherapy completed the Alcohol Use Disorders Identification Test (AUDIT) designed to detect risky alcohol consumption. They also completed a brief neuropsychological assessment (NPZ 5) composed by five measures. For this cross‐sectional analysis, we calculated rates of hazardous (AUDIT=8–15) or harmful (AUDIT=16–19) consumption and likely dependence (AUDIT>20). We explored the association between risky alcohol intakes (AUDIT>8) and clinical/demographical variables, conducting logistic regressions when significant association was found (p Results: Of the 146 included participants, the majority were male (86.3%), white (81.5%) and educated (mean years on formal education=15, SD=3.9). Average age was 47.6 years (SD=8.7), and 36.3% had risky consumption (29.5% hazardous, 6.2% harmful, 0.7% likely dependence). White ethnicity and male sex were positively associated with risky consumption (Table 1). After adjustments, white ethnicity remained significantly associated with risky consumption (1.64 [95% CI 0.34–2.95]; p=0.013). Better cognitive performance was associated with risky alcohol consumption in the univariate analysis (p Conclusions: Despite the substantially high prevalence of risky alcohol consumption, it was not associated with worse adherence, immunological or quality of life measures in this cohort of effectively suppressed patients but prevalence of likely alcohol dependency was extremely low. White patients were more vulnerable to risky consumption. Moreover, positive association between cognitive performance and risky alcohol consumption remained after adjustment. In our study, the association we found between cognitive function and alcohol consumption does not reflect the effect of alcohol dependency on cognition., Table 1: Association between clinical and demographical variables and risky alcohol consumption Coef. Std.Err. z p 95% Conf. interval Ethnicity 1.757 0.639 2.75 0.006 0.503–3.011 Sex −1.811 0.767 −2.36 0.018 [...]

Published
2014
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44. HIV-1 viral load and resistance in genital secretions in patients taking protease-inhibitor-based second-line therapy in Africa

Author

Hoppe, Anne, Giuliano, Marina, Lugemwa, Abbas, Thompson, Jennifer A, Floridia, Marco, Walker, Ann S, Senoga, Ismail, Abwola, Mary C, Pirillo, Maria F, Kityo, Cissy M, Arenas-Pinto, Alejandro, Paton, Nicholas I, and EARNEST Trial Team

Abstract

BACKGROUND: HIV is transmitted primarily through sexual intercourse, and the objective of this study was therefore to assess whether there is occult viral replication and resistance in genital secretions in patients on protease inhibitor (PI)-based second-line therapy. METHODS: HIV-infected adults taking ritonavir-boosted lopinavir with either two nucleoside reverse transcriptase inhibitors (NRTIs), raltegravir or as monotherapy for 96 weeks, were enrolled at seven clinical sites in Uganda. Viral load (VL) was measured in cervico-vaginal secretions or semen and in a corresponding plasma sample. Genotypic resistance was assessed in genital secretion samples and plasma samples. Results were compared between compartments and with the plasma resistance profile at first-line failure. RESULTS: Of the 111 participants enrolled (91 female, 20 male), 16 (14%) and 30 (27%) had VL >1,000 and >40 copies/ml, respectively, in plasma; 3 (3%) and 23 (21%) had VL >1,000 copies/ml and >40 copies/ml, respectively, in genital secretions. There was 74% agreement between plasma and genital secretion VL classification above/below 40 copies/ml threshold (kappa-statistic =0.29; P=0.001). RT mutations (both NRTI and non-nucleoside reverse transcriptase inhibitor) were detected in genital secretions in four patients (similar profile to corresponding plasma sample at first-line failure) and PI mutations were detected in two (one polymorphism with no impact on resistance; one with high-level PI resistance). CONCLUSIONS: High level (>1,000 copies/ml) viral replication and development of new RT or PI resistance in the genital compartment were rare. The risks of transmission arising from resistance evolution in the genital compartment are likely to be low on PI-based second-line therapy.

Published
2017

45. Anxiety and depression symptoms in young people with perinatally acquired HIV and HIV affected young people in England

Author

Le Prevost, Marthe, Arenas-Pinto, Alejandro, Melvin, Diane, Parrott, Francesca, Foster, Caroline, Ford, Deborah, Evangeli, Michael, Winston, Alan, Sturgeon, Kate, Rowson, Katie, Gibb, Diana M., Judd, Ali, Le Prevost, Marthe, Arenas-Pinto, Alejandro, Melvin, Diane, Parrott, Francesca, Foster, Caroline, Ford, Deborah, Evangeli, Michael, Winston, Alan, Sturgeon, Kate, Rowson, Katie, Gibb, Diana M., and Judd, Ali

Abstract

Adolescents with perinatal HIV (PHIV) may be at higher risk of anxiety and depression than HIV negative young people. We investigated the prevalence of symptoms of anxiety and depression in PHIV and HIV-affected (siblings of PHIV and/or had an HIV positive mother) young people in England. Symptoms were measured using the Hospital Anxiety and Depression Scale (HADS) scores. A cross-sectional analysis was conducted of data from 283 young people with PHIV aged 13-21 years and 96 HIV-affected young people aged 13-23 years in the Adolescents and Adults Living with Perinatal HIV (AALPHI) cohort. Linear regression investigated factors associated with higher (worse) anxiety and depression scores.115 (41%) and 29 (30%) PHIV and HIV-affected young people were male, median age was 16 [interquartile range 15,18] and 16 [14,18] years and 241 (85%) and 71 (74%) young people were black African, respectively. There were no differences in raw or z-scores of anxiety and depression, or self-esteem, between PHIV and HIV-affected participants (all p values >0.1). Across both PHIV and HIV-affected groups, factors associated with higher anxiety scores were having more carers in childhood, speaking a language other than English at home, lower self-esteem, and ever thinking life was not worth living and lower social functioning. Factors associated with higher depression scores were male sex, death of one or both parents, ever excluded from school, lower self-esteem and lower social functioning. This study found anxiety and depression scores were similar among PHIV and HIV-affected young people and similar to that of population norms. Other studies have found an association between poorer mental health and worse health outcomes in young people with PHIV, highlighting the need to identify young people at increased risk and provide timely support.

Published
2018

46. Evaluation of cerebrospinal fluid virological escape in patients on long-term protease inhibitor monotherapy

Author

Arenas-Pinto, Alejandro, Stohr, Wolfgang, Clarke, Amanda, Williams, Ian, Beeching, Nicholas J, Minton, Jane, Lee, Vincent, Paton, Nicholas I, and Monotherapy, Protease Inhibitor

Subjects
medicine.medical_specialty, Time Factors, HIV Infections, Asymptomatic, Gastroenterology, Article, 03 medical and health sciences, 0302 clinical medicine, Cerebrospinal fluid, Internal medicine, Antiretroviral Therapy, Highly Active, medicine, HIV Protease Inhibitor, Effective treatment, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), In patient, 030212 general & internal medicine, Cerebrospinal Fluid, Pharmacology, medicine.diagnostic_test, Lumbar puncture, business.industry, HIV Protease Inhibitors, Viral Load, Surgery, Infectious Diseases, Treatment Outcome, RNA, Viral, Female, medicine.symptom, business, Viral load, 030217 neurology & neurosurgery
Abstract

Background A strategy of protease inhibitor (PI) mono-therapy with re-introduction of triple therapy in those who rebound has been shown to be a safe and effective treatment simplification approach for long-term management. We sought evidence for cerebrospinal fluid (CSF) virological escape in patients on long-term PI monotherapy. Methods We performed lumbar puncture in asymptomatic participants with suppressed plasma HIV RNA after 96 weeks on the PI monotherapy arm (PI-mono) of the PIVOT trial. We also report CSF HIV RNA concentration in trial participants who were investigated for neurological/ neurocognitive symptoms during the trial regardless of study arm allocation. Results All 11 asymptomatic participants on PI-mono who were tested had undetectable CSF HIV RNA at week 96. One of the three symptomatic participants on PI-mono had CSF HIV RNA of 1,895 copies/ml (undetectable in plasma) and neither of two symptomatic participants on triple therapy had CSF HIV RNA detected. Conclusions CSF virological escape appears rare in asymptomatic patients on PI monotherapy and may not warrant routine CSF monitoring, but patients with symptoms merit more concern.

Published
2017

47. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, Lane, H Clifford, Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, and Wenner, Christine

Abstract

There is a clinical need for therapeutics for COVID-19 patients with acute hypoxemic respiratory failure whose 60-day mortality remains at 30-50%. Aviptadil, a lung-protective neuropeptide, and remdesivir, a nucleotide prodrug of an adenosine analog, were compared with placebo among patients with COVID-19 acute hypoxaemic respiratory failure.

Published
2024
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48. Brain Perfusion, Regional Volumes, and Cognitive Function in Human Immunodeficiency Virus–positive Patients Treated With Protease Inhibitor Monotherapy

Author

Haddow, Lewis J, primary, Godi, Claudia, additional, Sokolska, Magdalena, additional, Cardoso, M Jorge, additional, Oliver, Ruth, additional, Winston, Alan, additional, Stöhr, Wolfgang, additional, Clarke, Amanda, additional, Chen, Fabian, additional, Williams, Ian G, additional, Johnson, Margaret, additional, Paton, Nick, additional, Arenas-Pinto, Alejandro, additional, Golay, Xavier, additional, and Jäger, Hans Rolf, additional

Published
2018
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49. The Protease Inhibitor Monotherapy Versus Ongoing Triple Therapy (PIVOT) trial : a randomised controlled trial of a protease inhibitor monotherapy strategy for long-term management of human immunodeficiency virus infection

Author

Paton, Nicholas, Stöhr, Wolfgang, Oddershede, Lars, Arenas-Pinto, Alejandro, Walker, Simon Mark, Sculpher, Mark John, and Dunn, David

Abstract

Background Standard-of-care antiretroviral therapy (ART) for human immunodeficiency virus (HIV) infection uses a combination of drugs, until now considered essential to minimise treatment failure and development of drug resistance. Protease inhibitors (PIs) are potent with a high genetic barrier to resistance and have the potential for use as monotherapy after viral load (VL) suppression achieved on combination therapy. However, longer-term resistance and toxicity risks are uncertain. Objective To compare the effectiveness, toxicity profile and cost-effectiveness of PI monotherapy with those of standard-of-care triple therapy in a pragmatic long-term clinical trial. Design Open-label, parallel-group, randomised controlled trial. Setting Forty-three HIV clinical centres in the UK NHS. Participants HIV-positive adults taking standard combination ART with a suppressed VL for ≥ 6 months. Interventions Patients were randomised to maintain ongoing triple therapy (OT) or switch to a strategy of physician-selected ritonavir-boosted PI monotherapy (PI-mono), with prompt return to combination therapy in the event of VL rebound. Main outcome measures The primary outcome was reduction of future drug options, defined as new intermediate-/high-level resistance to one or more drugs to which the patient’s virus was considered to be sensitive at trial entry (non-inferiority comparison, 10% margin). Secondary outcomes included confirmed virological rebound, serious drug- or disease-related complications, total grade 3 or 4 adverse events (AEs), neurocognitive function change, cluster of differentiation 4 (CD4) cell count change, change in health-related quality of life, cardiovascular risk change, health-care costs and health economic analysis. Results In total, 587 participants were randomised (77% male, 68% white) to OT (n = 291) or PI-mono (n = 296) and followed for a median of 44 months, of whom 2.7% withdrew/were lost to follow-up. One or more episodes of confirmed VL rebound were observed in eight patients (Kaplan–Meier estimate 3.2%) in the OT group and 95 patients (35.0%) in the PI-mono group [absolute risk difference 31.8%, 95% confidence interval (CI) 24.6% to 39.0%; p

Published
2016

50. Genital Secretion HIV RNA Shedding in HIV-Positive Patients on Ritonavir-Boosted Protease Inhibitor Monotherapy or Standard Combination ART: A Cross-Sectional Sub-Study from the PIVOT Trial

Author

Arenas-Pinto, Alejandro, Stöhr, Wolfgang, Khoo, Saye, Clarke, Amanda, Beeching, Nicholas, Warwick, Zoe, Lee, Vincent, Else, Laura, Wiggins, Rebecca, Ferns, Bridget, Nastouli, Eleni, Dunn, David, Lacey, Charles J, and Paton, Nicholas I

Abstract

Background Protease inhibitors (PI) have relatively low penetration into the genital tract, raising concerns about the potential for genital HIV RNA shedding in patients taking PI-based regimens, particularly PI monotherapy (PI-mono).Methods We measured HIV RNA and PI drug concentrations in samples of semen, cervicovaginal and rectal mucosa secretions, and plasma in patients after 48–96 weeks on PI-mono or standard triple therapy.Results A total of 85 participants were recruited. Of the 43 participants on PI-mono (70% on darunavir [DRV]/ ritonavir [r]), 3 had detectable virus in semen or vaginal secretions (all below quantification limit), and none in rectal mucosa or plasma. Among those taking triple therapy, five had detectable virus in semen or vaginal secretions (HIV RNA >50 copies/ml in one), none in rectal mucosa and one in plasma. The median (IQR) concentration of DRV and atazanavir in semen (659.7 [339–1,089] and 128.8 [63–368] ng/ml, respectively) and cervico-vaginal samples (2,768 [312–7,879] and 1,836 [359–3,314] ng/ml, respectively) exceeded their protein adjusted median inhibition concentration (MIC50). DRV concentration in rectal secretions showed higher variability compared with concentration in the other sites, with particularly high rectal secretion/blood ratios (median 8.4, IQR 2.6–68.7:1).Conclusions We found no substantive evidence of HIV shedding in patients taking PI-mono, suggesting that PIs provide adequate control of virus in the genital compartment and are unlikely to lead to ongoing sexual transmission.

Published
2020
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