Manuscripts
Showing 1583 manuscripts.
Pharmacokinetics and Safety of Levofloxacin for Treatment of Rifampicin-Resistant Tuberculosis During Pregnancy and the Postpartum Period: Results from IMPAACT P1026s.
Citation
Jennifer A. Hughes, Mauricio Pinilla, Kristina M. Brooks, Ahizechukwu C. Eke, Alice Stek, Brookie M. Best, Mark Mirochnick, Renee Browning, Lubbe Wiesner, Kathleen George, Kevin Knowles, Petra De Koker, Nahida Chakhtoura, Anneke C. Hesseling, Eric Decloedt, David E. Shapiro, Marije van Schalkwyk, IMPAACT P1026s Protocol Team. Pharmacokinetics and Safety of Levofloxacin for Treatment of Rifampicin-Resistant Tuberculosis During Pregnancy and the Postpartum Period: Results from IMPAACT P1026s.. Clinical Pharmacology. 2025. 64: 619-630. PMID: 40155501Year
2025
Journal
Clinical Pharmacology
Study
P1026S
The effect of pregnancy on the population pharmacokinetics of levofloxacin in South Africans with rifampicin-resistant tuberculosis
Citation
Sharon Sawe, Lufina Tsirizani, Richard Court, Kamunkhwala Gausi, Asanda Poswa, Tasnim Badat, Lubbe Wiesner, Marian Loveday, Gary Maartens, Francesca Conradie, Paolo Denti. The effect of pregnancy on the population pharmacokinetics of levofloxacin in South Africans with rifampicin-resistant tuberculosis. Antimicrobial Agents and Chemotherapy. 2025. PMID: 40167446Year
2025
Journal
Antimicrobial Agents and Chemotherapy
Study
P1078
Hepatotoxicity Among People Living with HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and Pharmacogenetics
Citation
Grace Montepiedra, Lisa Aaron, Gerhard Theron, Katie McCarthy, Sarah Bradford, Tsungai Chipato, Tichoana Vhembo, Lynda Stranix-Chibanda, Deo Wabwire, Gaerolwe Masheto, Patrick Jean-Philippe, Timothy R Sterling, Adriana Weinberg, Amita Gupta. Hepatotoxicity Among People Living with HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and Pharmacogenetics. 2025. PMID: 40237651Year
2025
Study
P1078
The Representative Studies Rubric: A Tool for Diversity in Clinical Trials
Citation
Brian Minalga, Rona Siskind, Russell Campbell, Tyler Adamson, Mary Allegra Cermak, Annet Davis, Eddie Givens, Molly Dyer, Katie McCarthy, Nicole A. MontaƱez, Rhonda White, RSR Working Group. The Representative Studies Rubric: A Tool for Diversity in Clinical Trials. American Journal of Bioethics. 2025. 1-15. PMID: 40293363Year
2025
Journal
American Journal of Bioethics
Model-informed once-daily dosing strategy for bedaquiline and delamanid in children, adolescents and adults with tuberculosis
Citation
Yu-Jou Lin, Louvina E. van der Laan, Mats O. Karlsson, Anthony J. Garcia-Prats, Anneke C. Hesseling, Elin M. Svensson. Model-informed once-daily dosing strategy for bedaquiline and delamanid in children, adolescents and adults with tuberculosis. Clinical Pharmacology & Therapeutics. 2025. 117: 1292-1302. PMID: 39731394Year
2025
Journal
Clinical Pharmacology & Therapeutics
Study
IMPAACT 2020
Safety, Tolerability, and Pharmacokinetics of Long-Acting Broadly Neutralizing HIV-1 Monoclonal Antibody VRC07-523LS in HIV-1-Exposed Newborn Infant
Citation
Coleen K. Cunningham, Elizabeth J. McFarland, Petronella Muresan, Edmund V. Capparelli, Charlotte Perlowski, Benjamin Johnston, Frederic Bone, Lynette Purdue, Dwight E. Yin, Jack Moye, Hans M.L. Spiegel, Sai Majji, Gerhard B. Theron, Hilda A. Mujuru, Murli Purswani, Grace Alvarez, Jaime G. Deville, Carrie Chambers, Emily Brown, Paul A. Harding, Nicole H. Tobin, Kwang Low, Lucio Gama, IMPAACT P1112 Team. Safety, Tolerability, and Pharmacokinetics of Long-Acting Broadly Neutralizing HIV-1 Monoclonal Antibody VRC07-523LS in HIV-1-Exposed Newborn Infant. Journal of the Pediatric Infectious Diseases Society. 2025. 14: piaf002. PMID: 39821046Year
2025
Journal
Journal of the Pediatric Infectious Diseases Society
Study
P1112
Efficacy, safety, and tolerability of dispersible and immediate release abacavir/dolutegravir/lamivudine tablets in children with HIV: IMPAACT 2019 week 48 results
Citation
Helena Rabie, Dwight E. Yin, Shawn Ward, Yasha Rani, Lauren Ziemba, Kristina M. Brooks, Tim R. Cressey, Gaerolwe R. Masheto, Haseena Cassim, Jaime G. Deville, Ponego L. Ponatshego, Faeezah Patel, Linda Aurpibul, Shaun L. Barnabas, Iris Mustich, Anne Coletti, Barbara Heckman, Chelsea Krotje, Ellen Townley, Jack Moye, Sai Majji, Edward P. Acosta, Kevin Ryan, Hardik Chandasana, Cynthia H. Brothers, Ann M. Buchanan, Patricia M. Flynn, IMPAACT 2019 Study Team. Efficacy, safety, and tolerability of dispersible and immediate release abacavir/dolutegravir/lamivudine tablets in children with HIV: IMPAACT 2019 week 48 results. 2025. PMID: 40440679Year
2025
Study
IMPAACT 2019
Inflammation, antiretroviral therapy continuation, and HIV disease progression in postpartum women with HIV
Citation
Rupak SHIVAKOTI, Mark J. Giganti, Michael M Lederman, Rachel Ketchum, Sean S. Brummel, Daniela Moisi, Allen T Matubu, Sufia Dadabhai, Dhayendre Moodley, Avy Violari, Lameck Chinula, Maxensia Owor, Amita Gupta, Taha E. Taha, Patricia M. Flynn, Judith S. Currier, Mary Glenn Fowler, PROMISE Study Team. Inflammation, antiretroviral therapy continuation, and HIV disease progression in postpartum women with HIV. Journal of AIDS. 2025. PMID: 40476693Year
2025
Journal
Journal of AIDS
Study
1077BF, 1077FF
Pharmacokinetics of first-line tuberculosis drugs rifampin, isoniazid, ethambutol, and pyrazinamide during pregnancy and postpartum with and without efavirenz-based antiretroviral treatment: IMPAACT P1026s study
Citation
Marije Van Schalkwyk, Adrie Bekker, Eric Decloedt, Jiajia Wang, Gerhard B. Theron, Mark F. Cotton, Ahizechukwu C. Eke, Tim R. Cressey, Deo Wabwire, David E. Shapiro, Kira Bacon, Kevin Knowles, Kathleen George, Renee Browning, Nahida Chakhtoura, Kittipong Rungruengthanakit, Lubbe Wiesner, Edmund V. Capparelli, Alice M. Stek, Mark Mirochnick, Brookie M. Best, IMPAACT P1026s Protocol Team. Pharmacokinetics of first-line tuberculosis drugs rifampin, isoniazid, ethambutol, and pyrazinamide during pregnancy and postpartum with and without efavirenz-based antiretroviral treatment: IMPAACT P1026s study. Journal Antimicrobial Agents and Chemotherapy. 2025. 69: e0005225. PMID: 40741959Year
2025
Journal
Journal Antimicrobial Agents and Chemotherapy
Study
P1026S
Negative Control Outcome Adjustment in Early-Phase Randomized Trials: Estimating Vaccine Effects on Immune Responses in HIV Exposed Uninfected Infants
Citation
Ethan Ashby, Genevieve Fouda, Holly Janes, Bo Zhang, Youyi Fong. Negative Control Outcome Adjustment in Early-Phase Randomized Trials: Estimating Vaccine Effects on Immune Responses in HIV Exposed Uninfected Infants. Statistics In Medicine. 2025. 44: e70142. PMID: 40492758Year
2025
Journal
Statistics In Medicine