Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.
Eligibility
- Age range
- 16–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures * Willing and able to provide written informed consent for their own and their infant's study participation * At entry, 16-45 years of age (inclusive) * At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best o…
Interventions
- DrugGlecaprevir/pibrentasvir
100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg
Locations (10)
- USC LALos Angeles, California
- David Geffen School of Medicine at UCLALos Angeles, California
- University of Colorado DenverAurora, Colorado
- Univ. of Florida JacksonvilleJacksonville, Florida
- Lurie Children's Hospital of ChicagoChicago, Illinois
- Johns Hopkins University BaltimoreBaltimore, Maryland