๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV (NCT07040319)

Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: USC LA โ€” Los Angeles, California

Age range: 16 Years to 45 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • USC LA โ€” Los Angeles, California
  • David Geffen School of Medicine at UCLA โ€” Los Angeles, California
  • University of Colorado Denver โ€” Aurora, Colorado
  • Univ. of Florida Jacksonville โ€” Jacksonville, Florida
  • Lurie Children's Hospital of Chicago โ€” Chicago, Illinois
  • Johns Hopkins University Baltimore โ€” Baltimore, Maryland
  • SUNY Stony Brook โ€” Stony Brook, New York
  • Bronx-Lebanon Hospital Center โ€” The Bronx, New York
  • Jacobi Medical Center โ€” The Bronx, New York
  • Baylor College of Medicine//Texas Children's Hospital โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (323) 865-1561

Email: ytr@usc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Hepatitis C clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—