IMPAACT 2019 

Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age.

Rationale

A variety of methods will be used to evaluate adherence to daily administration of ABC/DTG/3TC in this study. For all children, questionnaires will be administered at time points designated in the Schedule of Evaluations. In addition, for children undergoing intensive PK sampling, more objective methods of assessing adherence such as texted video, video streaming, and in-person directly observed therapy will be used to confirm daily dosing between enrollment and the day of intensive PK sampling. Data obtained through these methods will assist with determining whether failure to reach PK targets is due to challenges with adherence or administration versus actual PK differences in the pediatric study population. Relationships between PK-based adherence measures and other adherence measures will be explored, which may provide useful insights into selection of adherence measures to be used in future pediatric studies.

Investigators

• Dr Faeezah Patel
• Dr Elizea Horne
• Dr Mrinmayee Dhar
• Dr Gabriella Benade
• Othusitse Segalo
• Tiffany Seef

Latest Update

August 2022

For more about IMPAACT 2019 please email rhicomms@wrhi.ac.za