IMPAACT 2026
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drug during Pregnancy and Postpartum.
Rationale
The predecessor of this study, MPAACT P1026s, gained approval in 2003 and enrolled over 1000 pregnant/postpartum women. It investigated the pharmacokinetics (PK) of more than 25 HIV and TB drugs in these women, resulting in 27 published manuscripts presenting these data. P1026s findings were referenced in 32% of the 76 perinatal pharmacology studies in the 2017 version of the United States Department of Health and Human Services (DHHS) Perinatal HIV Guidelines, and in 63% of the 27 drug sections within these guidelines.
Data from the P1026 study’s elvitegravir-cobicistat arm served as the foundation for the 2018 revision of the labels for cobicistat and cobicistat-containing fixed-dose products like Stribild, Genvoya, Prezcobix, Eyotaz, and Symtuza. These labels now caution against using these products during pregnancy due to significantly reduced exposures of cobicistat and elvitegravir during pregnancy.
Investigators
- Prof Lee Fairlie, Principal Investigator
- Dr Faeezah Patel, Sub Investigator
- Dr Elizea Horne, Sub Investigator
- Dr Mrinmayee Dhar, Sub Investigator
- Dr Muneerah Khan, Sub Investigator
- Dr Jeanne Coetzee, Sub Investigator
- Othusitse Segalo, Clinical Associate
- Tiffany Seef, Clinical Associate
Latest Update
March 2024
For more about IMPAACT 2026 please email rhicomms@wrhi.ac.za
