Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Summary
Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.
Description
Up to 40 adult-participants with HIV viral suppression will be enrolled, in pairs with their infants, to achieve 30 evaluable adult-participants overall. The study will include women who initiated CAB LA + RPV LA outside the study, prior to study entry, either pre-conception (including on the day of conception) or post-conception.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide written informed consent for study participation for self and infant * At screening, age 18 years or older * Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry * At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up * Was diagnosed with HIV prior to the current pregnancy * Has a documented plasma HIV RNA result less than 50 copies…