Status:
COMPLETED
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
AbbVie
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hepatitis C Infection
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV...
Detailed Description
The study was conducted in two steps. In Step 1, participants received four weeks of treatment with G/P for acute HCV infection and were then followed 24 weeks post treatment. Participants with HCV re...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Acute HCV infection (or reinfection) within 24 weeks prior to entry
- Detectable HCV RNA at the screening visit
- Exclusion Criteria
- Any HCV treatment during the current acute HCV infection episode
- Known preexisting cirrhosis
- Acute HIV-1 infection
- Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
- Chronic use of systemically administered immunosuppressive agents
- History of solid organ transplantation
- History of conditions that could interfere with the absorption of the study drug
- Concurrent use of prohibited medications
- Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation
- Females who are pregnant or breastfeeding
- Males with pregnant female partner
Exclusion
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04042740
Start Date
November 20 2019
End Date
August 22 2023
Last Update
July 11 2024
Active Locations (12)
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1
Ucsd, Avrc Crs (701)
San Diego, California, United States, 92103
2
University of California, San Francisco HIV/AIDS CRS (801)
San Francisco, California, United States, 94110
3
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States, 80045
4
Whitman-Walker Institute, Inc. CRS (31791)
Washington D.C., District of Columbia, United States, 20005