Clinical trials will be designed with optimized strategies to ensure research among African women while providing evidence that informs safety and efficacy of new products supporting expedited approval by stringent regulatory authorities.
To support the progression of the critical path products, clinical studies will be conducted in the US and in Africa. First in human and early clinical trials will focus on safety and formulation performance through pharmacokinetics/pharmacodynamic evaluations. While first in human studies generally rely upon enrollment of healthy low-risk participants, there is recognition that earlier inclusion of adolescent girls and young women, pregnant and breastfeeding women and female sex workers living in high incidence settings in Sub-Saharan Africa is desirable. Although inclusion of HIV uninfected pregnant and breastfeeding women in these investigational new drug studies will be prioritized, feasibility and acceptability of research implementation will depend upon the availability of safety data, relative risk to benefit ratios associated with the investigational new drug products use related to their indications and the ethical considerations of local drug regulators, ethics committees, potential end-users and other stakeholders.
Most of the planned first in human trials will occur from 2023 onwards. Depending on the regulatory status of the products, safety data availability, types of study endpoints, and specific characteristics of product formulations, options of conducting parallel/staggered trials in the US and Africa or directly starting with first in human studies in Africa will be weighed. End-users and key influencers will be engaged from the early design to delivery stages with lessons learned leveraged from past/ongoing clinical trials and socio-behavioral research. Every effort will be made to engage local partners in these trials by soliciting interest for protocol concepts and employing the MATRIX steering committee to match local partner capacity to the proposed study. Efforts will be made to create clinical trial synergies across products which could allow for inclusion of more than one product type in early-stage clinical studies.