Abrams EJ, Mofenson LM, Pozniak A, et al. - Pregnant women are excluded from clinical trials, which results in a lack of safety and pharmacokinetic data for antiretroviral drugs (ARVs) in pregnancy, creating clear risks to pregnant women living with HIV (PWLHIV), and their infants. In Geneva, Switzerland, the World Health Organization convened a Paediatric Antiretroviral Drug Optimization group meeting, December 10–12, 2018. Task was provided to the group comprising of clinicians, scientists, HIV program managers, regulators, and community representatives, to account how ARVs are analyzed in PWLHIV, define alternative strategies to study ARVs in PWLHIV, determine paths to shorten the timeline to determine safe use of new agents during pregnancy, and describe strategies to collaborate with regulators and industry to change longstanding practices. Study of most new ARVs do not involve pregnant populations until after drug licensure, primarily opportunistically among women who become pregnant while taking the ARV of interest. For acceleration of the timeline, they suggest the necessity for earlier completion of preclinical studies and a new paradigm, namely—under certain conditions—enable women who become pregnant while participating in phase 3 ARV studies the option of remaining on study and enroll pregnant women into phase 3 trials of new agents to obtain preliminary safety and dosing and efficacy data. Observations overall suggest the urgent requirement for a revision of the current approach to the study of antiretrovirals in pregnant women to increase timely access and safe use of new agents during pregnancy.