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Your search keyword '"Mhembere, Tsungai P."' showing total 4 results
Start Over Author "Mhembere, Tsungai P."
4 results on '"Mhembere, Tsungai P."'

1. Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1–Exposed Newborn Infants

Author

McFarland, Elizabeth J, Cunningham, Coleen K, Muresan, Petronella, Capparelli, Edmund V, Perlowski, Charlotte, Morgan, Patricia, Smith, Betsy, Hazra, Rohan, Purdue, Lynette, Harding, Paul A, Theron, Gerhard, Mujuru, Hilda, Agwu, Allison, Purswani, Murli, Rathore, Mobeen H, Flach, Britta, Taylor, Alison, Lin, Bob C, McDermott, Adrian B, Mascola, John R, Graham, Barney S, Rossouw, Magdel, Rossouw, Lindie, Louw, Jeanne, Vhembo, Tichaona, Mhembere, Tsungai Patience, Matibe, Petronella, Mahmoudi, Saniyyah, Maldonado, Alexandrea, Maraqa, Nizar, Baig, Mahboobullah M, Rogo, Tanya, Cavallo, Martha, Collinson-Streng, Aleisha, Anderson, Thuy, Golden, W Christopher, Persaud, Deborah, Puga, Ana M, Robinson, Lisa-Gaye, Eysallenne, Zulma, Leon, Dayana, Paul, Mary E, McMullen-Jackson, Chivon, Buschur, Shelley, Pontifes, Mariam, Sung, Joyce, Glenny, Carrie, Dunn, Jennifer, and Navarro, Kacey

Subjects
Paediatrics, Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Perinatal Period - Conditions Originating in Perinatal Period, Pediatric, Infectious Diseases, Vaccine Related, Pediatric AIDS, Sexually Transmitted Infections, Immunization, Vaccine Related (AIDS), Prevention, HIV/AIDS, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Anti-Retroviral Agents, Antibodies, Monoclonal, Broadly Neutralizing Antibodies, Dose-Response Relationship, Drug, Female, HIV Antibodies, HIV Infections, HIV-1, Half-Life, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Male, broadly neutralizing antibodies, VRC01LS, VRC01, neonates, monoclonal antibodies, bNAb, perinatal HIV-1 transmission, pharmacokinetics, passive immunization, HIV-1 prevention, International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundPerinatal human immunodeficiency virus type 1 (HIV-1) continues to occur due to barriers to effective antiretroviral prevention that might be mitigated by long-acting broadly neutralizing monoclonal antibodies (bNAbs).MethodsAn extended half-life bNAb, VRC01LS, was administered subcutaneously at 80 mg/dose after birth to HIV-1-exposed, nonbreastfed (cohort 1, n = 10) and breastfed (cohort 2, n = 11) infants. Cohort 2 received a second dose (100 mg) at 12 weeks. All received antiretroviral prophylaxis. VRC01LS levels were compared to VRC01 levels determined in a prior cohort.ResultsLocal reactions (all grade ≤2) occurred in 67% and 20% after dose 1 and dose 2, respectively. The weight-banded dose (mean 28.8 mg/kg) of VRC01LS administered subcutaneously achieved a mean (standard deviation) plasma level of 222.3 (71.6) µg/mL by 24 hours and 44.0 (11.6) µg/mL at week 12, prior to dose 2. The preestablished target of ≥50 µg/mL was attained in 95% and 32% at weeks 8 and 12, respectively. The terminal half-life was 37-41 days. VRC01LS level after 1 dose was significantly greater (P

Published
2021

2. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants

Author

Cunningham, Coleen K, McFarland, Elizabeth J, Morrison, R Leavitt, Capparelli, Edmund V, Safrit, Jeffrey T, Mofenson, Lynne M, Mathieson, Bonnie, Valentine, Megan E, Perlowski, Charlotte, Smith, Betsy, Hazra, Rohan, Purdue, Lynette, Muresan, Petronella, Harding, Paul A, Mbengeranwa, Tapiwa, Robinson, Lisa-Gaye, Wiznia, Andrew, Theron, Gerhard, Lin, Bob, Bailer, Robert T, Mascola, John R, Graham, Barney S, Aldrovandi, Grace, Bone, Frederic, Dayton, Dale, Johnston, Benjamin, Morgan, Patricia, Myers, Kathryn, Tobin, Nicole, Zimmer, Bonnie, Rossouw, Magdel, Rossouw, Lindie, Louw, Jeanne, Dobroszycki, Joanna, Burey, Marlene, Auguste, Raphaelle, Graham, Kathleen K, Major-Wilson, Hanna, Mhembere, Tsungai, Maturure, Sukunena, Bwakura-Dangarembizi, Mutsa, Barr, Emily, Dunn, Jennifer, Glenny, Carrie, Chambers, Carrie, Baig, Mahboobullah Mirza, Purswani, Murli, Deville, Jaime G, Nielsen-Saines, Karin, Shin, Christina, Carter, Michele F, Chahroudi, Ann, Ahonen, Alexis, Badell, Martina, Chakraborty, Rana, Agwu, Allison, Golden, W Christopher, Anderson, Thuy, Collinson-Streng, Aleisha, Diaz-Velasco, Rodrigo, Rosario, Nicolas, Pérez, Elvia, Marrero, Wanda I, Febo, Irma, Santos, Ruth, and Zorrilla, Carmen D

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Sexually Transmitted Infections, Vaccine Related (AIDS), Clinical Research, Prevention, Immunization, Vaccine Related, Pediatric AIDS, Biotechnology, Pediatric, Breastfeeding, Lactation and Breast Milk, Infectious Diseases, HIV/AIDS, Perinatal Period - Conditions Originating in Perinatal Period, 6.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Good Health and Well Being, Africa, Antibodies, Monoclonal, Broadly Neutralizing Antibodies, Female, HIV Antibodies, HIV Infections, HIV-1, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Injections, Subcutaneous, Linear Models, Male, United States, broadly neutralizing antibodies, mother-to-child transmission of HIV, neonates, VRC01, IMPAACT P1112 team, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAlthough mother-to-child human immunodeficiency virus (HIV) transmission has dramatically decreased with maternal antiretroviral therapy, breast milk transmission accounts for most of the 180 000 new infant HIV infections annually. Broadly neutralizing antibodies (bNAb) may further reduce transmission.MethodsA Phase 1 safety and pharmacokinetic study was conducted: a single subcutaneous (SC) dose of 20 or 40 mg/kg (Dose Groups 1 and 2, respectively) of the bNAb VRC01 was administered to HIV-exposed infants soon after birth. Breastfeeding infants (Dose Group 3) received 40 mg/kg SC VRC01 after birth and then 20 mg/kg/dose SC monthly. All infants received appropriate antiretroviral prophylaxis.ResultsForty infants were enrolled (21 in the United States, 19 in Africa). Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. VRC01 was rapidly absorbed after administration, with peak concentrations 1-6 days postdose. The 40 mg/kg dose resulted in 13 of 14 infants achieving the serum 50 micrograms (mcg)/mL target at day 28. Dose Group 3 infants maintained concentrations greater than 50 mcg/mL throughout breastfeeding.ConclusionsSubcutaneous VRC01 as single or multiple doses is safe and well tolerated in very young infants and is suitable for further study to prevent HIV transmission in infants.

Published
2020

4. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, Lockman, Shahin, Best, Brookie M., Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A., Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D., Ponatshego, Ponego L., Tirelo, Lesedi, Seme, Boitshepo J., Modise, Georginah O., Raesi, Mpho S., Budu, Marian E., Ramogodiri, Moakanyi, Oliveira, Ricardo H., Hofe, Cristina B, Fernandes de Abreu, Thalita, Pestanha, Lorena M., João, Esaú, Sidi, Leon C., Fuller, Trevon, Cruz, Maria L.S, Pinto, Jorge, Ferreira, Flãvia, Correa Jr, Mãrio, Romeiro, Juliana, Pilotto, Jose H., Fernandes, Luis E.B.C, Moreira, Luiz F., Gomes, Ivete M., Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R., Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C., Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R., Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, Mitchell, Charles D., Drada, Adriana, Alvarez, Grace A., Scott, Gwendolyn B., Rathore, Mobeen, Mahmoudi, Saniyyah, Shabbir, Adnan, Maraqa, Nizar, Mandima, Patricia F., Mutambanengwe, Mercy, Maonera, Suzen, Chareka, Gift, Nematadzira, Teacler, Chanaiwa, Vongai, Matubu, Taguma A., Tamirepi, Kevin, Maturure, Sukunena, Mhembere, Tsungai, Vhembo, Tichaona, Chidemo, Tinashe, and Whalen, Frances

Abstract

Drugs taken during pregnancy can affect maternal and child health outcomes, but few studies have compared the safety and virological efficacy of different antiretroviral therapy (ART) regimens. We report the primary safety outcomes from enrolment up to 50 weeks post partum and a secondary virological efficacy outcome at 50 weeks post partum of three commonly used ART regimens for HIV-1.

Published
2023
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