Project overview
For people living with HIV (PLWH), globally TB is the most common cause of death. Effective treatment of active TB and TB prevention in PLWH could prevent many of these deaths. However, TB treatment requires 6 months of daily oral medication and TPT can require up to 9 months of tablets, but for PLWH in areas with a high TB burden continuous TPT is recommended.
TPT completion rates are low, but shorter medication regimens have a higher completion rate in both TPT and TB treatment. Improving completion rates is important as failure to complete these therapies decreases treatment efficacy and increases the chance of the development of drug resistance.
LAI options of this medication should improve completion, and therefore efficacy, as it provides a much simpler and convenient medication regimen, reducing the drug burden for both patients and health systems. Simplifying the regimen should reduce the medication burden enough that completion rates increase and the TB related deaths in PLWH decrease.
CELT's Objectives
- Development of LAI formulations for next-generation DARQs and companion agent(s) based on a novel solid drug nanoparticles technology platform.
- Identification of target exposures for LAI formulations and demonstration of proof-of-concept in vivo efficacy studies.
- Nonclinical evaluation of injection site safety and tolerability, LAI stability, and CMC (Chemistry, Manufacturing and Controls) of LAI regimens to enable an IND (Investigational New Drug) application for use in TPT and/or the continuation phase of active TB treatment.
- Non-clinical studies to confirm the sterilizing efficacy of LAI regimens for use as a single dose for TPT and for single or multiple dose treatment during the continuation phase of active TB therapy.
Awarding body
Related publications
- CROI abstract | One-Dose Efficacy of Long-Acting Injectable Diarylquinoline in Mouse Model of TB Preventive Therapy
Presented by Nuermberger, E. (2024)