Publications by authors named "Leigh A Sawyer"
Article Synopsis
- Oral drug absorption, particularly of clofazimine, can be significantly affected by diarrhea associated with infections like cryptosporidiosis in HIV-infected adults.
- A population pharmacokinetic model using data from a study of 23 participants revealed that severe diarrhea can reduce clofazimine bioavailability by more than sixfold.
- Understanding these effects is crucial for optimizing dosing regimens to improve treatment outcomes for patients experiencing gastrointestinal issues.
Article Synopsis
- Cryptosporidium is a gut pathogen that particularly affects people with weakened immune systems, such as those with HIV, and the CRYPTOFAZ trial in Malawi tested clofazimine's effectiveness for treating this infection.
- The study used various diagnostic methods, including qPCR and ELISA, to examine 586 individuals and monitor those who were part of the trial for pathogen shedding and other co-infections.
- The findings revealed that while qPCR was more sensitive for detecting Cryptosporidium, ELISA had more variable results; additionally, a new Cryptosporidium species was found, and enterotoxigenic E. coli was also linked to diarrhea in some participants.
Background: An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials.
Methods: We present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi.