Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study

Authors: Best, Brookie M, Capparelli, Edmund V, Hanley, Sherika, Mathiba, Sisinyana Ruth, Naidoo, Megeshinee, Ounchanum, Pradthana, Patel, Faeezah, Paul, Mary E, Townley, Ellen, Vandermeulen, Kati, Whitson, Kyle, Zabih, Sara, Lowenthal, Elizabeth D ^*, Chapman, Jennifer, Ohrenschall, Rachel, Calabrese, Katherine, Baltrusaitis, Kristin, Heckman, Barbara, Yin, Dwight E, Agwu, Allison L, Harrington, Conn, Van Solingen-Ristea, Rodica M, McCoig, Cynthia C, Adeyeye, Adeola, Kneebone, Jared, Chounta, Vasiliki, Smith-Anderson, Christiana, Camacho-Gonzalez, Andres, D'Angelo, Jessica, Bearden, Allison, Crauwels, Herta, Huang, Jenny, Buisson, Sarah, Milligan, Ryan, Ward, Shawn, Bolton-Moore, Carolyn ^*, Gaur, Aditya H ^*

Source: In The Lancet HIV April 2024 11(4):e222-e232

Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Authors: Buisson, Sarah, Cheung, S. Y. Amy, Chounta, Vasiliki, Deprez, Isabelle, Desmond, Alicia Catherine, Han, Kelong, Hanley, Sherika, Lin, Yu-Wei, Patel, Faeezah, Paul, Mary E., Roberts, Gilly, Whitson, Kyle, Zabih, Sara, Gaur, Aditya H ^{*, *}, Capparelli, Edmund V ^*, Calabrese, Katherine, Baltrusaitis, Kristin, Marzinke, Mark A, McCoig, Cynthia, Van Solingen-Ristea, Rodica M, Mathiba, Sisinyana Ruth, Adeyeye, Adeola, Moye, John H, Heckman, Barbara, Lowenthal, Elizabeth D, Ward, Shawn, Milligan, Ryan, Samson, Pearl, Best, Brookie M, Harrington, Conn M, Ford, Susan L, Huang, Jenny, Crauwels, Herta, Vandermeulen, Kati, Agwu, Allison L, Smith-Anderson, Christiana, Camacho-Gonzalez, Andres, Ounchanum, Pradthana, Kneebone, Jared L, Townley, Ellen, Bolton Moore, Carolyn

Source: In The Lancet HIV April 2024 11(4):e211-e221

Paediatric abacavir–lamivudine fixed-dose dispersible tablets and ritonavir-boosted lopinavir granules in neonates exposed to HIV (PETITE study): an open-label, two-stage, single-arm, phase 1/2, pharmacokinetic and safety trial

Authors: Bekker, Adrie, Salvadori, Nicolas, Rabie, Helena, du Toit, Samantha, Than-in-at, Kanchana, Groenewald, Marisa, Cressey, Ratchada, Nielsen, James, Capparelli, Edmund V, Lallemant, Marc, Cotton, Mark F, Cressey, Tim R ^*

Source: In The Lancet HIV February 2024 11(2):e86-e95

HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study

Authors: Persaud, Deborah ^{a, *}, Bryson, Yvonne ^b, Nelson, Bryan S ^c, Tierney, Camlin ^c, Cotton, Mark F ^d, Coletti, Anne ^e, Jao, Jennifer ^f, Spector, Stephen A ^g, Mirochnick, Mark ^h, Capparelli, Edmund V ^g, Costello, Diane ^b, Szewczyk, Joseph ^a, Nicodimus, Nicol ⁱ, Stranix-Chibanda, Lynda ⁱ, Kekitiinwa, Adeodata R ^j, Korutaro, Violet ^j, Reding, Christina ^k, Carrington, Mary N ^l, Majji, Sai ^m, Yin, Dwight E ⁿ, Jean-Philippe, Patrick ⁿ, Chadwick, Ellen G ^f

Source: In The Lancet HIV January 2024 11(1):e20-e30

Fexofenadine Plasma Concentrations to Estimate Systemic Exposure in Healthy Adults Using a Limited Sampling Strategy with a Population Pharmacokinetic Approach

Authors: Piscitelli, Joseph, Nikanjam, Mina, Capparelli, Edmund V., Blaquera, Chelsea L., Penzak, Scott R., Nolin, Thomas D., Paine, Mary F., Ma, Joseph D.

Source: Therapeutic drug monitoring. 45(4):539-545

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN633226657&indx=1&recIds=ETOCRN633226657

Model‐Informed Precision Dosing Guidance of Ethosuximide Developed from a Randomized Controlled Clinical Trial of Childhood Absence Epilepsy

Authors: Mizuno, Kana, Capparelli, Edmund V., Fukuda, Tsuyoshi, Dong, Min, Adamson, Peter C., Blumer, Jeffery L., Cnaan, Avital, Clark, Peggy O., Reed, Michael D., Shinnar, Shlomo, Vinks, Alexander A., Glauser, Tracy A.

Source: Clinical pharmacology & therapeutics. 114(2):459-469

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100187856701.0x000001&indx=1&recIds=ETOCvdc_100187856701.0x000001

Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Authors: Lyke, Kirsten E, Berry, Andrea A, Mason, Kaitlin, Idris, Azza H, O'Callahan, Mark, Happe, Myra, Strom, Larisa, Berkowitz, Nina M, Guech, Mercy, Hu, Zonghui, Castro, Mike, Basappa, Manjula, Wang, Lu, Low, Kwang, Holman, LaSonji A, Mendoza, Floreliz, Gordon, Ingelise J, Plummer, Sarah H, Trofymenko, Olga, Strauss, Kathleen S, Joshi, Sudhaunshu, Shrestha, Biraj, Adams, Matthew, Chagas, Andrezza Campos, Murphy, Jittawadee R, Stein, Judy, Hickman, Somia, McDougal, Andrew, Lin, Bob, Narpala, Sandeep R, Vazquez, Sandra, Serebryannyy, Leonid, McDermott, Adrian, Gaudinski, Martin R, Capparelli, Edmund V, Coates, Emily E, Wu, Richard L, Ledgerwood, Julie E, Dropulic, Lesia K, Seder, Robert A

Source: Lancet infectious diseases. 23(5):578-588

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100187708300.0x000001&indx=1&recIds=ETOCvdc_100187708300.0x000001

Brief Report: Long-Term Clinical, Immunologic, and Virologic Outcomes Among Early-Treated Children With HIV in Botswana: A Nonrandomized Controlled Clinical Trial

Authors: Ajibola, Gbolahan, Maswabi, Kenneth, Hughes, Michael D., Bennett, Kara, Pretorius-Holme, Molly, Capparelli, Edmund V., Jean-Philippe, Patrick, Moyo, Sikhulile, Mohammed, Terence, Batlang, Oganne, Sakoi, Maureen, Ricci, Lucia, Lockman, Shahin, Makhema, Joseph, Kuritzkes, Daniel R., Lichterfeld, Mathias, Shapiro, Roger L.

Source: Journal of acquired immune deficiency syndromes. 92(5):393-398

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100187185277.0x000001&indx=1&recIds=ETOCvdc_100187185277.0x000001

Physiologically‐based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID‐19

Authors: Liu, Xiaomei I., Dallmann, André, Brooks, Kristina, Best, Brookie M., Clarke, Diana F., Mirochnick, Mark, Anker, John N., Capparelli, Edmund V., Momper, Jeremiah D.

Source: CPT: pharmacometrics & systems pharmacology. 12(2):148-153

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175280647.0x000001&indx=1&recIds=ETOCvdc_100175280647.0x000001

Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Authors: Young, Cheryl, Boyce, Colleen, Winkler, Jennifer, Holian, Susan, Greenberg, Nancy, George, Shirley, Kwon, Alyson, Dorsey, Brenda, Da Costa, Ana Raquel, Witt, William, Grays, Daryl, Gapasin, Arren, Bernal, Paula, Floyd, Jeffrey, Goldstein, Eric, Howe, Leslie, Lee, Myounghee, Marron, Jennifer, Brooks, Kelly, Turek, Lisa, Farley, Patricia, Frels, Shantel, Booth, Delores, Gall, Jason, Carlton, Kevin, Albright, Gabriela, Amharref, Nadia, Atallah, Kandace, Banappagari, Sashikanth, Bastani, Niutish, Blackstock, Daniel, Boonyaratanakornkit, Bobby, Carey, Elizabeth, Charlton, Adam, Chaudhuri, Rajoshi, Caringal, Alegria M., Chen, Mingzhong, Chen, Peifeng, Cheng, Wei, Gowetski, Daniel, Gulla, Krishana, Hastings, Erica, Horwitz, Joe, Ivleva, Vera, Kordella, Dan, Kueltzo, Lisa A., Lagler, Sara, Le, Matt, Lee, James, Lei, Paula, Li, Yile, Nagy, Attila, Patel, Aakash, Runsewe, Peyi, Shadrick, Will, Shetty, Shamitha, Wang, Hairong, Webber, Calvin, Vejzagic, Farah, Yang, Yoo-Jung, Lyke, Kirsten E ^*, Berry, Andrea A, Mason, Kaitlin, Idris, Azza H, O'Callahan, Mark, Happe, Myra, Strom, Larisa, Berkowitz, Nina M, Guech, Mercy, Hu, Zonghui, Castro, Mike, Basappa, Manjula, Wang, Lu, Low, Kwang, Holman, LaSonji A, Mendoza, Floreliz, Gordon, Ingelise J, Plummer, Sarah H, Trofymenko, Olga, Strauss, Kathleen S, Joshi, Sudhaunshu, Shrestha, Biraj, Adams, Matthew, Chagas, Andrezza Campos, Murphy, Jittawadee R, Stein, Judy, Hickman, Somia, McDougal, Andrew, Lin, Bob, Narpala, Sandeep R, Vazquez, Sandra, Serebryannyy, Leonid, McDermott, Adrian, Gaudinski, Martin R, Capparelli, Edmund V, Coates, Emily E, Wu, Richard L, Ledgerwood, Julie E, Dropulic, Lesia K, Seder, Robert A

Source: In The Lancet Infectious Diseases May 2023 23(5):578-588

Impact of CYP2B6 genotype, tuberculosis therapy, and formulation on efavirenz pharmacokinetics in infants and children under 40 months of age

Authors: Nikanjam, Mina, Tran, Lana, Chadwick, Ellen G., Bwakura-Dangarembizi, Mutsa, Bolton Moore, Carolyn, Samson, Pearl, Spector, Stephen A., Chakhtoura, Nahida, Jean-Philippe, Patrick, Frenkel, Lisa, Zimmer, Bonnie, Benns, Alex, Libous, Jennifer, Capparelli, Edmund V.

Source: AIDS. 36(4):525-532

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100194406310.0x000001&indx=1&recIds=ETOCvdc_100194406310.0x000001

Maraviroc Population Pharmacokinetics Within the First 6 Weeks of Life

Authors: Liyanage, Marlon, Nikanjam, Mina, McFadyen, Lynn, Vourvahis, Manoli, Rogg, Luise, Moye, John, Chadwick, Ellen G., Jean-Philippe, Patrick, Mirochnick, Mark, Whitson, Kyle, Bradford, Sarah, Capparelli, Edmund V., Best, Brookie M.

Source: Pediatric infectious disease journal. 41(11):885-890

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100173022290.0x000001&indx=1&recIds=ETOCvdc_100173022290.0x000001

Safety and Pharmacokinetics of Intravenous 10-1074 and VRC01LS in Young Children

Authors: Capparelli, Edmund V., Ajibola, Gbolahan, Maswabi, Kenneth, Holme, Molly P., Bennett, Kara, Powis, Kathleen M., Moyo, Sikhulile, Mohammed, Terence, Maphorisa, Comfort, Hughes, Michael D., Seaton, Kelly E., Tomaras, Georgia D., Mosher, Shad, Taylor, Alison, O'Connell, Sarah, Narpala, Sandeep, Mcdermott, Adrian, Caskey, Marina, Gama, Lucio, Lockman, Shahin, Jean-Philippe, Patrick, Makhema, Joseph, Kuritzkes, Daniel R., Lichterfeld, Mathias, Shapiro, Roger L.

Source: Journal of acquired immune deficiency syndromes. 91(2):182-188

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100170824989.0x000001&indx=1&recIds=ETOCvdc_100170824989.0x000001

Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV

Authors: Momper, Jeremiah D., Wang, Jiajia, Stek, Alice, Shapiro, David E., Powis, Kathleen M., Paul, Mary E., Badell, Martina L., Browning, Renee, Chakhtoura, Nahida, Denson, Kayla, Rungruengthanakit, Kittipong, George, Kathleen, Capparelli, Edmund V., Mirochnick, Mark, Best, Brookie M.

Source: Journal of acquired immune deficiency syndromes. 89(3):303-309

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100155078841.0x000001&indx=1&recIds=ETOCvdc_100155078841.0x000001

Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s

Authors: Brooks, Kristina M., Pinilla, Mauricio, Stek, Alice M., Shapiro, David E., Barr, Emily, Febo, Irma L., Paul, Mary E., Deville, Jaime G., George, Kathleen, Knowles, Kevin, Rungruengthanakit, Kittipong, Browning, Renee, Chakhtoura, Nahida, Capparelli, Edmund V., Mirochnick, Mark, Best, Brookie M.

Source: Journal of acquired immune deficiency syndromes. 90(3):343-350

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100155477502.0x000001&indx=1&recIds=ETOCvdc_100155477502.0x000001

Optimizing Dolutegravir Initiation in Neonates Using Population Pharmacokinetic Modeling and Simulation

Authors: Piscitelli, Joseph, Nikanjam, Mina, Best, Brookie M., Acosta, Edward, Mirochnick, Mark, Clarke, Diana F., Capparelli, Edmund V., Momper, Jeremiah D.

Source: Journal of acquired immune deficiency syndromes. 89(1):108-114

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100157703365.0x000001&indx=1&recIds=ETOCvdc_100157703365.0x000001

Advancing the prevention and treatment of HIV in children: priorities for research and development

Authors: Abrams, Elaine, Archary, Moherndran, Bekker, Adrie, Capparelli, Edmund, Colbers, Angela, Cressey, Tim, Frigati, Lisa, Hafiz, Asma, Mukui, Irene, Penazzato, Martina, Rakhmanina, Natella, Rojo, Pablo, Ruel, Theodore, Sam-Agudu, Nadia, Sugandhi, Nandita, Townsend, Claire, Vicari, Marissa, Watkins, Melynda, Townsend, Claire L, Sam-Agudu, Nadia A, Ruel, Theodore D, Cressey, Tim R, Capparelli, Edmund V, Abrams, Elaine J

Source: In The Lancet HIV September 2022 9(9):e658-e666

Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/IIa Trial

Authors: Yang, Jincheng, Jain, Sonia, Capparelli, Edmund V., Best, Brookie M., Son, Mary Beth, Baker, Annette, Newburger, Jane W., Franco, Alessandra, Printz, Beth F., He, Feng, Shimizu, Chisato, Hoshino, Shinsuke, Bainto, Emelia, Moreno, Elizabeth, Pancheri, Joan, Burns, Jane C., Tremoulet, Adriana H.

Source: In The Journal of Pediatrics April 2022 243:173-180

Abacavir dosing in neonates from birth to 3 months of life: a population pharmacokinetic modelling and simulation study

Authors: Bekker, Adrie ^*, Capparelli, Edmund V, Violari, Avy, Cotton, Mark F, Cababasay, Mae, Wang, Jiajia, Mathiba, Ruth, Wiesner, Lubbe, Wiznia, Andrew, Samson, Pearl, Browning, Renee, Moye, Jack, Nakwa, Firdose L, Decloedt, Eric, Rabie, Helena, Mirochnick, Mark, Cressey, Tim R

Source: In The Lancet HIV January 2022 9(1):e24-e31

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Authors: Moore, Carolyn Bolton, Baltrusaitis, Kristin, Best, Brookie M, Moye, John H, Townley, Ellen, Violari, Avy, Heckman, Barbara, Buisson, Sarah, Van Solingen-Ristea, Rodica M, Capparelli, Edmund V, Marzinke, Mark A, Lowenthal, Elizabeth D, Ward, Shawn, Krotje, Chelsea, Milligan, Ryan, Agwu, Allison L, Huang, Jenny, Cheung, S Y Amy, McCoig, Cynthia, Yin, Dwight E, Roberts, Gilly, Crauwels, Herta, Van Eygen, Veerle, Zabih, Sara, Masheto, Gaerolwe, Ounchanum, Pradthana, Aurpibul, Linda, Korutaro, Violet, Gaur, Aditya H, Whitson, Kyle, Whitton, Michael, Harrington, Conn M., Patel, Faeezah, Paul, Mary E., Hanley, Sherika, Vandermeulen, Kati, Lin, Yu-Wei, Deprez, Isabelle, Han, Kelong, Ford, Susan L., Collins, Jon W.

Source: The Lancet HIV; March 2025, Vol. 12 Issue: 3 pe191-e200, 10p